BioGX continuously monitors the evolution of SARS-CoV-2 variants to ensure our market leading SARS-CoV-2 real-time PCR tests will continue to detect emerging variants. Specifically, variants that belong to clades NB.1.8.1, LP.8.1, XEC, XFG, XFC, JN.1 and LF.7.9.
BioGX has performed in-silico analysis of complete high coverage Omicron genomes of the following sublineages in the Global Initiative on Sharing Avian Influenza Data (GISAID) EpiCoV™ database as of 18 July 2025 (Table 1).
Sequence analysis of the variant genomes was compared against the SARS-CoV-2 reference genome to identify any mutations within the regions of the nucleocapsid (N-gene) targeted by BioGX products.
Based on in-silico analysis conducted on 18 July 2025, the nucleotide mutations present in NB.1.8.1, LP.8.1, XEC, XFG, XFC, JN.1 and LF.7.9 clades will not affect the detection capability of the BioGX portfolio of SARS-CoV-2 real-time PCR tests targeting the N-gene and all variants analyzed will be detected.
BioGX continues to monitor emerging SARS-CoV-2 lineage variants and any mutations with the potential to impact performance.
Table 1. Summary of SARS-CoV-2 variant (omicron sublineage) complete high coverage sequences utilized for in-silico analysis.
Omicron Sublineages Analyzed by BioGX
Omicron Sublineage
Nextstrain clade
Emergence Location (Date)
No. Sequences Present and Analyzed (as of 18 July 2025)
BioGX continuously monitors the evolution of SARS-CoV-2 variants to ensure our market-leading SARS-CoV-2 RT-PCR tests will continue to detect emerging variants.
BioGX has completed in silico analysis of over 977 complete high coverage Omicron genomes of sublineages belonging to the NB.1.8.1 clade present in the Global Initiative on Sharing Avian Influenza Data (GISAID) EpiCoV™ database as of 02 June 2025.
Sequence analysis of the variant genomes was compared against the SARS-CoV-2 reference genome to identify any mutations within the regions of the nucleocapsid (N-gene) targeted by BioGX products.
Based on in-silico analysis 02 June 2025, the nucleotide mutations present in NB.1.8.1 clade will not affect the detection capability of the BioGX portfolio of SARS-CoV-2 products, and all variants analyzed will be detected.
BioGX continues to monitor emerging SARS-CoV-2 lineage variants and any mutations with the potential to impact performance.
The world of diagnostic testing has been revolutionized by the advent of molecular techniques. Among these, the polymerase chain reaction (PCR) has emerged as the most powerful and reliable method. PCR testing has not only transformed the way we diagnose diseases but also set a benchmark for precision and speed in the field of molecular diagnostics. Let’s explore the brilliance of PCR, its numerous applications, and how it continues to shape the modern diagnostic landscape.
Overview of PCR – How It Works and Why It’s Crucial in Molecular Testing At its core, PCR is a molecular technique designed to amplify and detect specific DNA sequences. Think of it as a molecular photocopier that takes a tiny fragment of genetic material and replicates it exponentially, allowing scientists and clinicians to detect even the smallest traces of pathogens or genetic abnormalities.
Here’s how PCR works PCR operates through a series of thermal cycles that include:
1. Denaturation – The DNA sample is heated to around 94-98°C, causing the double-stranded DNA to separate into two single strands.
2. Annealing – The temperature is lowered to 50-65°C, allowing short DNA primers to bind to the target sequences.
3. Extension – A heat-stable DNA polymerase (such as Taq polymerase) extends the primers by adding nucleotides, creating new DNA strands.
4. Repetition – This cycle is repeated multiple times, exponentially amplifying the DNA for detection and analysis.
Why PCR is Crucial in Molecular Testing PCR’s strength lies in its precision, sensitivity, and adaptability. It can detect the presence of infectious agents, genetic mutations, and other biomarkers with unparalleled accuracy. In a world where early and accurate diagnosis can mean the difference between life and death, PCR stands as the gold standard.
Common Applications of PCRPCR’s versatility has made it a cornerstone in various fields of diagnostics:
1. Infectious Disease Diagnostics PCR has become the backbone of infectious disease testing. Unlike traditional culture methods, which can take days, PCR delivers results in a matter of hours. It is extensively used to diagnose diseases such as:
COVID-19 – PCR was the gold standard for detecting SARS-CoV-2 due to its high sensitivity and specificity.
Influenza – PCR testing helps differentiate between strains of flu viruses for appropriate treatment.
Tuberculosis (TB) – PCR is used to detect Mycobacterium tuberculosis directly from sputum samples, improving diagnosis speed.
Sexually Transmitted Infections (STIs) – PCR is employed in the detection of chlamydia, gonorrhea, and human papillomavirus (HPV).
2. Genetic Testing Genetic disorders and inherited conditions can be identified through PCR by detecting specific genetic mutations. From prenatal genetic screening to cancer genomics, PCR continues to illuminate the underlying causes of various conditions.
Newborn Screening – Identifies genetic disorders like cystic fibrosis and sickle cell anemia early in life.
Cancer Genomics – Detects mutations in genes associated with cancers, aiding in personalized treatment.
Carrier Screening – Determines whether a person carries a gene for inherited diseases such as Tay-Sachs or Huntington’s disease.
3. Forensic Science and Paternity Testing Outside the clinical realm, PCR has made its mark in forensic science, where it helps identify suspects and analyze crime scene evidence. It is also an essential tool in research laboratories for cloning, gene expression studies, and more.
4. Environmental and Food Safety Testing PCR is also used to detect contaminants, pathogens, or genetically modified organisms (GMOs) in food products and environmental samples, ensuring safety and compliance with regulations.
Benefits of PCR – High Sensitivity, Specificity, and Rapid Turnaround Times The benefits of PCR are as remarkable as its capabilities. Here’s why it is often referred to as the gold standard:
1. High Sensitivity and Specificity PCR can detect even minute quantities of genetic material, making it highly reliable for diagnosing diseases at early stages. Unlike serological tests that rely on the presence of antibodies (which take time to develop), PCR identifies the pathogen’s genetic material directly, leading to a more accurate diagnosis.
2. Targeted Accuracy/strong> By targeting unique DNA sequences, PCR ensures accurate identification of the pathogen or mutation in question, minimizing false positives.
3. Rapid Turnaround Times
Traditional diagnostic techniques often require days or weeks to produce results. PCR, on the other hand, can provide answers within hours, enabling timely interventions and treatment.
Pandemic Response – During COVID-19, PCR testing played a crucial role in controlling virus spread through quick and accurate identification of infected individuals.
Hospital Settings – PCR aids in the rapid diagnosis of life-threatening infections such as sepsis, enabling prompt treatment.
4. Versatility PCR can be adapted for various applications, including:
Detecting RNA viruses using reverse transcription PCR (RT-PCR).
Quantifying DNA using real-time PCR (qPCR).
Identifying multiple pathogens simultaneously with multiplex PCR.
5. Automation and Scalability With advances in PCR technology, automation has significantly increased testing efficiency. High-throughput PCR systems enable mass testing, making them indispensable in clinical laboratories and public health initiatives.
BioGX’s Role – How BioGX Solutions Fit into the Modern PCR Testing Landscape In the evolving world of molecular diagnostics, companies like BioGX have taken PCR to new heights by offering innovative solutions that streamline and enhance molecular testing processes. BioGX has emerged as a leading innovator in PCR-based molecular diagnostics, providing cutting-edge solutions tailored for modern healthcare needs. The company specializes in developing real-time PCR reagents that streamline molecular testing workflows across diverse sectors.
1. Simplifying PCR Testing with Ready-to-Use Reagents BioGX offers pre-mixed, lyophilized PCR reagents that eliminate the need for complex reagent preparation. These user-friendly solutions:
Reduce human error.
Minimize contamination risks.
Enhance consistency and reproducibility in test results.
2. Wide Range of PCR Reagents BioGX provides PCR-based solutions for detecting infectious pathogens, genetic mutations, and food safety hazards. Their reagents support:
COVID-19 and respiratory virus panels.
Sexually transmitted infection (STI) testing.
Urinary tract infection testing.
Antimicrobial testing.
3. Compatibility with Open PCR Platforms BioGX’s PCR reagents are designed to be compatible with various PCR instruments, ensuring flexibility and ease of integration into existing laboratory workflows.
4. Point-of-Care and Decentralized Testing BioGX is at the forefront of making PCR testing accessible outside of centralized labs. Their innovative PCR solutions enable:
Rapid testing at hospitals, clinics, and mobile labs.
Faster patient diagnosis and treatment decisions.
5. Commitment to Quality and Regulatory Compliance BioGX adheres to strict quality standards, ensuring that their PCR assays meet ISO13485 and other global regulatory requirements. This commitment to quality makes their solutions reliable for molecular diagnostics worldwide.
PCR has revolutionized molecular diagnostics, establishing itself as the gold standard for rapid and accurate disease detection. Its unmatched sensitivity, specificity, and versatility make it indispensable across medical, forensic, and environmental testing fields. With companies like BioGX pushing the boundaries of innovation, PCR technology continues to evolve, making molecular testing more efficient, accessible, and impactful in global healthcare.
As the demand for precise and rapid diagnostics grows, PCR remains the cornerstone of molecular testing, helping save lives through early and accurate disease detection. Whether in hospitals, research labs, or point-of-care settings, PCR’s impact on healthcare is undeniable.
Disclaimer: Information in the blog is provided to educate and propagate general awareness and is not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of the information presented in the blog.
https://www.biogx.com/wp-content/uploads/2025/03/PCR_Standards.png500500Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2025-03-28 11:30:122025-03-28 15:04:19Molecular Testing with PCR: The Gold Standard for Rapid & Accurate Diagnosis
Urinary tract infections (UTIs) are one of the most common infections, affecting millions worldwide every year. Timely and accurate diagnosis is essential to prevent complications and ensure effective treatment. BioGX, a leader in molecular diagnostic solutions, offers multiplex qPCR assays designed to simplify and improve the detection of UTI pathogens. This comprehensive guide explores how UTIs are diagnosed and how BioGX’s innovative multiplex technology is changing the game for healthcare providers.
What is Urinary Tract Infection (UTI)? A urinary tract infection occurs when bacteria enter and multiply within the urinary system, which includes the kidneys, bladder, ureters, and urethra. While UTIs can affect any part of the urinary tract, most infections are typically found in the bladder and urethra. Common symptoms include:
Pain or burning during urination
Frequent urge to urinate
Cloudy or strong-smelling urine
Pelvic pain in women
If left untreated, a UTI can spread to the kidneys, potentially causing severe complications. Rapid and accurate diagnosis is critical to prevent such outcomes.
Traditional UTI Diagnostic Methods UTI diagnosis has traditionally involved several methods, which include:
1. Urine Culture Testing: Urine culture is the gold standard for diagnosing UTIs. A urine sample is incubated in a lab to detect bacterial growth, which typically takes 24–48 hours. Although accurate, this method requires a waiting period, which can delay treatmen
2. Urine Dipstick Test: A urine dipstick test provides quick results by detecting the presence of white blood cells, nitrites, and proteins in the urine, which may indicate an infection. However, dipstick tests are less accurate than urine cultures and may produce false positives or false negatives.
3. Microscopic Urine Analysis: Microscopic analysis involves examining a urine sample under a microscope to identify bacteria, white blood cells, and other indicators of infection. While faster than culture tests, it lacks the specificity needed for accurate diagnosis. While these traditional methods are useful, they often come with limitations like wait times, sensitivity issues, and the need for specialized lab facilities. This is where BioGX’s multiplex PCR technology provides a more efficient solution.
Introducing BioGX’s Multiplex Technology for UTI detection BioGX has developed a comprehensive multiplex PCR panels that allows clinical laboratories to detect multiple targets (such as specific bacteria or resistance genes) simultaneously, ensuring faster and more accurate results. This technology is particularly effective for diagnosing UTIs, as it enables the detection of various bacterial strains associated with urinary tract infections. How BioGX’s Multiplex Technology Works BioGX’s multiplex PCR technology is based on molecular diagnostics that target bacterial DNA. By leveraging real-time PCR (polymerase chain reaction), it can rapidly amplify and detect multiple bacterial strains within a single sample. Here’s a breakdown of how the process works:
1. Sample Collection and Preparation: A urine sample is collected from the patient, similar to traditional methods. The sample is then prepared for testing, with DNA extracted from any bacteria present in the sample. This step is crucial as it ensures that only bacterial DNA is targeted, minimizing the chances of contamination.
2. Multiplex Real-Time PCR Amplification:
Once the DNA is isolated, the real-time PCR process begins. PCR works by amplifying specific DNA sequences associated with common UTI pathogens, such as Escherichia coli, Klebsiella pneumoniae, and Staphylococcus saprophyticus. BioGX’s technology allows for simultaneous amplification of multiple bacterial DNA sequences, reducing testing time.
3. Detection of Pathogens and Resistance Genes
BioGX’s multiplex technology also detects antimicrobial resistance genes, which are markers of bacterial resistance to specific antibiotics. This feature is vital for clinicians, as it enables them to select the most effective antibiotic treatment based on the resistance profile of the bacteria.
4. Real-Time Results and Analysis
As the DNA is amplified, the system detects specific fluorescence signals, each corresponding to a different pathogen or resistance gene. These signals allow healthcare providers to identify the bacterial strains present and their resistance status in real-time, providing results in a matter of hours rather than days.
Advantages of BioGX’s Multiplex Technology in UTI Detection BioGX’s multiplex technology offers several key advantages over traditional diagnostic methods, making it a highly effective solution for UTI detection.
1. Speed and Efficiency
Unlike urine culture, which requires at least 24–48 hours for results, BioGX’s multiplex technology can deliver diagnostic insights within a few hours. This speed allows healthcare providers to make timely treatment decisions, improving patient outcomes.
2. Comprehensive Pathogen Detection
Traditional UTI tests often target a limited number of bacteria, potentially missing less common pathogens. BioGX’s multiplex technology, however, is designed to identify multiple bacterial species simultaneously. This comprehensive detection reduces the risk of missed infections, especially in complex or recurrent UTI cases.
3. Antimicrobial Resistance Profiling
One of the standout features of BioGX’s technology is its ability to identify antibiotic resistance genes. By determining which antibiotics a bacterial strain is resistant to, healthcare providers can avoid prescribing ineffective treatments, which helps reduce the spread of antimicrobial resistance.
4. Minimal Sample Requirement
With BioGX’s multiplex technology, only a small urine sample is required, making it an ideal option for settings where sample collection may be challenging. This minimal sample requirement also enhances patient comfort and streamlines the testing process.
Applications of BioGX’s Multiplex Technology in Clinical Settings
BioGX’s multiplex technology is particularly useful in various clinical scenarios, providing healthcare professionals with the flexibility they need to diagnose and treat UTIs effectively.
1. Emergency Room Settings: UTIs are a common reason for emergency room visits, especially among elderly patients. The rapid diagnostic capabilities of BioGX’s multiplex technology enable ER staff to diagnose infections and administer treatment in a single visit, improving patient care and reducing wait times.
2. Outpatient Clinics:
For outpatient clinics and urgent care centers, BioGX’s solution provides a fast and accurate method to diagnose UTIs without sending samples to a central lab. This quick turnaround time ensures that patients receive the appropriate treatment immediately.
3. Long-Term Care Facilities:
UTIs are a prevalent issue in nursing homes and long-term care facilities, where delays in diagnosis can lead to severe health complications. BioGX’s multiplex technology provides these facilities with a practical solution for on-site testing, allowing caregivers to detect and treat infections promptly.
How BioGX’s Multiplex Technology Supports Antibiotic Stewardship
Antibiotic stewardship is the responsible use of antibiotics to minimize resistance. BioGX’s technology supports this initiative by:
Reducing the overuse of broad-spectrum antibiotics
Providing rapid results, which minimizes unnecessary antibiotic prescriptions
By helping healthcare providers prescribe effective, targeted antibiotics, BioGX’s multiplex technology contributes significantly to global antibiotic stewardship efforts.
The Future of UTI Pathogen Detection with BioGX’s Multiplex Technology
BioGX is continuously refining its multiplex technology to meet the evolving needs of healthcare providers. Future developments may include expanded pathogen panels, enhanced resistance gene detection, and even faster testing processes. As molecular diagnostics advance, BioGX aims to stay at the forefront of innovation, empowering healthcare providers with the tools they need to combat UTIs and other infections effectively.
Conclusion: BioGX’s Multiplex PCR Technology – A Game Changer in UTI Pathogen Detection
BioGX’s multiplex technology offers a powerful solution for detecting pathogens with speed, accuracy, and precision. Its ability to detect multiple pathogens and resistance genes within a single assay streamlines and simplifies the laboratory workflows. For laboratories validating and adopting BioGX’s innovative multiplex technology means enabling faster treatment decisions, improved patient outcomes, and a stronger commitment to antibiotic stewardship. In the face of growing antibiotic resistance and rising UTI cases, BioGX’s technology adoption by clinical laboratories is helping shape a healthier future for all.
Disclaimer: Information in the blog is provided to educate and propagate general awareness and not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of information presented in the blog.
https://www.biogx.com/wp-content/uploads/2025/01/Uti_blogs_imgs.png400501Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2025-01-06 01:42:292025-03-28 11:49:32A Comprehensive Guide to UTI Diagnosis: Employing BioGX’s Multiplex PCR Technology for fast and accurate Testing
The global health community has once again turned its attention to Mpox (formerly known as Monkeypox) as reports of new outbreaks have emerged in various regions. The recent resurgence of Mpox is a stark reminder that zoonotic diseases, which jump from animals to humans, remain a significant challenge to global public health. BioGX, as a leader in molecular diagnostics, is committed to providing the tools and knowledge necessary to combat these emerging threats. This blog explores the challenges posed by the resurgence of Mpox, its broader implications, and the strategies we must employ moving forward.
The Challenges of Mpox Resurgence
1. Emerging Variants and Transmission Patterns: One of the primary challenges in addressing the resurgence of Mpox is the emergence of new variants that may have altered transmission dynamics. While Mpox was previously considered a relatively rare disease with limited human-to-human transmission, recent outbreaks have shown a concerning increase in cases, particularly in densely populated urban areas. This shift suggests changes in the virus’s behavior, possibly due to mutations that enhance its transmissibility or ability to evade the immune system.
2. Limited Awareness and Diagnostic Infrastructure: Despite the global response to the COVID-19 pandemic, which heightened awareness of infectious diseases, Mpox remains underrecognized in many regions. Limited awareness among healthcare providers and the general public can lead to delayed diagnosis and treatment, exacerbating the spread of the disease. Moreover, many regions lack the diagnostic infrastructure required for rapid and accurate detection of Mpox, hindering timely interventions.
3. Public Health Response and Resource Allocation: The global response to emerging infectious diseases is often hampered by competing priorities and limited resources. As the world continues to grapple with the long-term impacts of COVID-19, public health systems may be stretched thin, making it challenging to allocate adequate resources to combat the resurgence of Mpox. Ensuring a swift and coordinated response is crucial to preventing the disease from gaining a foothold in vulnerable populations.
Broader Implications of the Resurgence
1. Impact on Global Health Security:
The resurgence of Mpox serves as a stark reminder of the interconnectedness of global health. Zoonotic diseases like Mpox do not respect borders, and their spread can have far-reaching consequences for global health security. The ongoing outbreaks underscore the need for a robust and coordinated international response to emerging infectious diseases, with a focus on early detection, rapid response, and cross-border collaboration.
2. The Role of Diagnostics in Containing Outbreaks: Accurate and timely diagnostics are at the heart of any effective outbreak response. As a leading manufacturer of molecular diagnostics, BioGX plays a crucial role in providing the tools necessary to detect Mpox at its earliest stages. Our Monkeypox PCR Assay, designed for precise and reliable detection, is an essential component of the global effort to contain the spread of the virus. By enabling early identification of cases, our assays empower healthcare providers to take swift action, reducing the risk of widespread transmission.
3. Lessons Learned and the Path Forward:
The resurgence of Mpox offers valuable lessons for the global health community. It highlights the importance of continuous surveillance, investment in diagnostic infrastructure, and the need for public health preparedness. As we navigate this resurgence, it is essential to apply the lessons learned from past outbreaks, including the COVID-19 pandemic, to strengthen our response strategies.
The Path Forward: BioGX’s Commitment to Global Health
At BioGX, we are committed to supporting global health initiatives by providing innovative diagnostic solutions that address the challenges of emerging infectious diseases. Our Monkeypox PCR Assay is a testament to our dedication to improving public health outcomes through reliable and accessible diagnostics. As the situation continues to evolve, BioGX will remain at the forefront, collaborating with healthcare providers, researchers, and public health authorities to ensure that we are equipped to meet the challenges of Mpox head-on.
Key Takeaways for Healthcare Providers:
Stay Informed: Keep up to date with the latest information on Mpox transmission, symptoms, and treatment options.
Utilize Reliable Diagnostics: Leverage advanced diagnostic tools like the BioGX Monkeypox PCR Assay for early detection and confirmation of cases.
Collaborate and Communicate: Work closely with local and international health authorities to share information, resources, and best practices for managing Mpox outbreaks.
Conclusion:
The recent resurgence of Mpox is a call to action for the global health community. By understanding the challenges, recognizing the implications, and taking decisive steps forward, we can mitigate the impact of this zoonotic disease. At BioGX, we are proud to contribute to this effort, providing the diagnostic solutions necessary to safeguard public health and prevent the spread of Mpox. Together, we can navigate this resurgence and build a more resilient global health system.
Learn more about BioGX Xfree™ Monkeypox Direct PCR Assay.
Disclaimer: Information in the blog is provided to educate and propagate general awareness and not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of information presented in the blog.
https://www.biogx.com/wp-content/uploads/2024/09/monkey-pox-virus_biogx.jpg400615Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2024-09-13 08:41:112025-02-20 15:54:33Understanding the Recent Resurgence of Mpox: Challenges, Implications, and the Path Forward
BioGX continuously monitors the evolution of SARS-CoV-2 variants to ensure our market leading SARS-CoV-2 RT-PCR tests will continue to detect emerging variants.
BioGX has completed in silico analysis of over 290,000 complete high coverage Omicron genomes of sublineages belonging to the JN.1, EG.5, BA.2.86, XBB.1.5, XBB.1.16, HV.1, HK.3, JD.1.1, and JG.3 clades present in the Global Initiative on Sharing Avian Influenza Data (GISAID) EpiCoV™ database as of 31 December, 2023.
Sequence analysis of the variant genomes was compared against the SARS-CoV-2 reference genome to identify any mutations within the regions of the nucleocapsid (N-gene), membrane (M-gene), and the coding region of the ORF1a gene (RdRp) targeted by BioGX products.
Based on in-silico analysis on 07th August 2024 and empirical testing, the nucleotide mutations present in JN.1, EG.5, XBB.1.5, XBB.1.16, HV.1, HK.3, JD.1.1, JG.3, BA.2.86 and the BA.2.86 sublineages KP.3.1.1, KP.3, LB.1, KP.2.3 and KP.2 will not affect the detection capability of the BioGX portfolio of SARS-CoV-2 products and all variants analyzed will be detected.
BioGX continues to monitor emerging SARS-CoV-2 lineage variants and any mutations with the potential to impact performance.
Omicron Sublineages Analyzed by BioGX
Omicron sublineage
Nextstrain clade
Emergence Location (Date)
No. Sequences Present and Analyzed
(as of 31DEC2023)
JN.1
23I
Luxembourg / Iceland (AUG 2023)
15,548
EG.5
23D
Denmark
(JUL 2023)
1795
BA.2.86
21L
Denmark
(JUL 2023)
416
XBB.1.5
23A
USA (OCT 2022)
172,673
XBB.1.16
23B
USA (JAN 2023)
33,318
HV.1
23F
China (JAN 2023)
30,422
HK.3
23H
USA (OCT 2022)
22,572
JD.1.1
23A
USA (JUL 2023)
7,601
JG.3
23F
France (JUL2023)
8,370
https://www.biogx.com/wp-content/uploads/2024/08/august_2024_blog.jpg401495Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2024-08-09 06:53:142024-08-09 06:58:36August 2024 Update: BioGX in silico analysis of SARS-CoV-2 variants of interest and emerging variants
BioGX continuously monitors the evolution of SARS-CoV-2 variants to ensure our market leading SARS-CoV-2 RT-PCR tests will continue to detect emerging variants.
BioGX has completed in silico analysis of over 290,000 complete high coverage Omicron genomes of sublineages belonging to the JN.1, EG.5, BA.2.86, XBB.1.5, XBB.1.16, HV.1, HK.3, JD.1.1, and JG.3 clades present in the Global Initiative on Sharing Avian Influenza Data (GISAID) EpiCoV™ database as of 31 December, 2023 (Table 1). Sequence analysis of the variant genomes was compared against the SARS-CoV-2 reference genome to identify any mutations within the regions of the nucleocapsid (N-gene), membrane (M-gene), and the coding region of the ORF1a gene (RdRp) targeted by BioGX products.
Based on in silico analysis and empirical testing, the nucleotide mutations present in the JN.1, EG.5, BA.2.86, XBB.1.5, XBB.1.16, HV.1, HK.3, JD.1.1, and JG.3 clades at the time of this analysis will not affect the detection capability of the BioGX portfolio of SARS-CoV-2 products and all variants analyzed will be detected.
BioGX continues to monitor emerging SARS-CoV-2 lineage variants and any mutations with the potential to impact performance.
Table 1. Number of sequences analyzed for each Omicron sublineage available from GISAID as of 31 December 2023.
Omicron Sublineages Analyzed by BioGX
Omicron sublineage
Nextstrain clade
Emergence Location (Date)
No. Sequences Present and Analyzed
(as of 31DEC2023)
JN.1
23I
Luxembourg / Iceland (AUG 2023)
15,548
EG.5
23D
Denmark
(JUL 2023)
1795
BA.2.86
21L
Denmark
(JUL 2023)
416
XBB.1.5
23A
USA (OCT 2022)
172,673
XBB.1.16
23B
USA (JAN 2023)
33,318
HV.1
23F
China (JAN 2023)
30,422
HK.3
23H
USA (OCT 2022)
22,572
JD.1.1
23A
USA (JUL 2023)
7,601
JG.3
23F
France (JUL2023)
8,370
https://www.biogx.com/wp-content/uploads/2023/09/img_covid19_scaled1.jpg788940Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2024-05-25 09:47:492024-09-13 05:53:40December 2023 Update: BioGX in silico analysis of SARS-CoV-2 variants of interest and emerging variants
Urinary tract infections (UTIs) are among the most common bacterial infections, affecting millions of individuals worldwide each year. Prompt and accurate diagnosis is essential for guiding appropriate treatment and preventing complications. In recent years, PCR (polymerase chain reaction) reagents have emerged as valuable tools in the diagnosis of UTIs, offering advantages in sensitivity, specificity, and speed compared to traditional microbiology methods. In this article, we’ll explore how PCR reagents are revolutionizing UTI testing and improving patient care.
1. Understanding PCR Reagents in UTI Testing:
PCR reagents are essential components used to amplify and detect specific DNA sequences in clinical samples, such as urine.
– In UTI testing, PCR reagents target genetic markers unique to common uropathogens, such as Escherichia coli, Klebsiella pneumoniae, and Enterococcus faecalis.
– By amplifying and detecting genetic markers specific to these pathogens, PCR assays can rapidly and accurately identify their presence in urine samples, even at low cell counts which are hard to grow and detect by traditional culture methods.
2. Advantages of PCR Reagents in UTI Diagnosis:
Sensitivity: PCR assays using high-fidelity DNA polymerases can detect bacterial DNA with exceptional sensitivity, enabling the diagnosis of UTIs even in cases with low bacterial loads. Specificity: PCR assays can distinguish between different bacterial species and strains, providing clinicians with valuable information for targeted antibiotic therapy. Speed: PCR assays offer rapid turnaround times, with results typically available within a few hours, allowing for prompt initiation of appropriate treatment. Automation: PCR assays can be automated, allowing for high-throughput testing in clinical laboratories, reducing manual labor and increasing efficiency.
3. Applications of PCR Reagents in UTI Testing:
Detection of Uropathogens: PCR assays targeting specific bacterial genes, such as those encoding virulence factors or antibiotic resistance determinants, can identify uropathogens and provide additional information for treatment decisions. Antimicrobial Susceptibility Testing:Antimicrobial Susceptibility Testing: PCR-based methods can detect genetic markers associated with antimicrobial resistance, guiding the selection of appropriate antibiotics and helping to combat the rise of antibiotic resistance in UTIs. Syndromic Panels:Multiplex PCR assays can simultaneously detect multiple uropathogens and differentiate between bacterial and viral causes of UTIs, offering comprehensive diagnostic information in a single test.
4. Challenges and Considerations:
Standardization: Ensuring the accuracy and reliability of PCR assays requires standardization of protocols, quality control measures, and validation studies.
Cost:While PCR assays may offer advantages in sensitivity and speed, they may be more costly than traditional culture-based methods, necessitating careful consideration of cost-effectiveness.
The Challenge of UTI Diagnosis
Traditional methods of UTI diagnosis, such as urine culture and microscopy, have limitations in terms of sensitivity, specificity, and turnaround time. These methods often require prolonged incubation periods and may miss low-level bacterial infections, leading to delayed treatment and potential complications. Moreover, distinguishing between symptomatic infection and asymptomatic bacteriuria can be challenging, particularly in certain patient populations.
In contrast, PCR technology offers a rapid and highly sensitive alternative to traditional UTI diagnostic methods. By targeting specific bacterial DNA sequences present in urine samples, PCR can detect the presence of UTI-causing pathogens with unparalleled accuracy. PCR reagents, which contain all the necessary components for PCR amplification and detection, play a crucial role in facilitating this process.
PCR Reagents: A Cornerstone of Molecular UTI Testing
BioGX custom-manufactured PCR reagents offer a comprehensive solution for the rapid and accurate detection of bacterial pathogens present in urine samples. Packaged in a single tube format, BioGX’s PCR reagents* streamline the testing process, minimize hands-on time and simplify workflow for laboratories. By combining all necessary components for PCR amplification and detection into a single lyophilized mastermix, BioGX ensures laboratories can achieve consistent and reliable performance, during their validation studies and routine testing.
Advantages of BioGX’s PCR Reagents for UTI Testing:
1. High Sensitivity:
BioGX’s PCR reagents* are optimized to detect low levels of bacterial DNA, even in cases of low bacterial load, ensuring reliable detection of UTI pathogens from urine samples.
2. Specificity: With carefully designed primer sets targeting conserved regions of bacterial genomes, BioGX’s PCR reagents* offer exceptional specificity, minimizing the risk of false-positive results and ensuring accurate detection.
3. Rapid Turnaround Time: By leveraging the speed and efficiency of PCR technology, BioGX’s PCR reagents* provide results within hours, enabling timely initiation of targeted antibiotic therapy and improving patient outcomes.
4. User-Friendly FormatPackaged in a single lyophilized tube format, BioGX’s PCR reagents* are easy to use, requiring minimal hands-on manipulation and reducing the risk of contamination, thereby enhancing laboratory efficiency and productivity.
Conclusion:
PCR reagents have transformed the landscape of UTI testing, offering unparalleled sensitivity, specificity, and speed compared to traditional methods. By harnessing the power of PCR technology, clinicians can diagnose UTIs with greater precision, guide targeted antibiotic therapy, and improve patient outcomes. As PCR assays continue to evolve and become more accessible, they hold tremendous promise for enhancing the diagnosis and management of UTIs, ultimately benefiting patients and healthcare systems alike.
*Custom manufactured as per customer specified requirements
Disclaimer: Information in the blog is provided to educate and propagate general awareness and not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of information presented in the blog.
https://www.biogx.com/wp-content/uploads/2024/05/uti_blog2_img.jpg449556Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2024-05-23 03:54:382024-05-24 14:00:10Enhancing UTI Detection with PCR Reagents
In the realm of infectious diseases, timely and accurate detection is crucial for effective management and control. Candida auris, an emerging multidrug-resistant fungus, presents a formidable challenge to healthcare systems worldwide. Scientists and healthcare professionals strive to combat this elusive pathogen where and the choice of detection methods is paramount. In this blog post, we delve into some testing methods available for Candida auris detection, focusing particularly on Polymerase Chain Reaction (PCR) and comparing it with other approaches.
Understanding Candida auris Detection
Detecting Candida auris poses unique challenges due to its ability to mimic other Candida species and its resistance to multiple antifungal agents. Traditional culture-based methods often yield inconclusive results or fail to identify C. auris accurately. Therefore, molecular diagnostic techniques have gained prominence for their ability to offer rapid and specific detection of this elusive pathogen.
PCR: The Gold Standard in Molecular Detection
PCR has revolutionized the field of molecular diagnostics, offering unparalleled sensitivity and specificity in pathogen detection. In the case of Candida auris, PCR assays target specific genetic markers unique to the fungus, enabling rapid and accurate identification. By amplifying and detecting signature DNA sequences characteristic of C. auris, PCR provides a highly sensitive and specific diagnostic tool, crucial for timely intervention and infection control measures.
Advantages of PCR for Candida auris Detection:
1. High Sensitivity: PCR can detect low levels of C. auris DNA, even in samples with low fungal burden.
2. Rapid Turnaround Time: PCR assays offer results within 2 -4 hours, allowing for prompt initiation of targeted antifungal therapy.
3. Specificity: PCR assays can distinguish C. auris from other Candida species with high specificity, reducing the likelihood of false-positive results.
4. Automation: Automated PCR platforms streamline the testing process, minimizing hands-on time and enhancing workflow efficiency in clinical laboratories.
Other Testing Methods for Candida auris Detection While PCR represents a cornerstone in the molecular detection of Candida auris, several alternative approaches exist, each with its own advantages and limitations:
1. Culture-Based Methods: Traditional culture-based techniques remain essential for confirming C. auris infections and determining antifungal susceptibility. However, they are time-consuming and may lack sensitivity, particularly in cases of low fungal burden as the primary testing solution.
2. Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS): MALDI-TOF MS enables rapid identification of microorganisms based on their protein profiles. While effective for identifying Candida species, including C. auris, it may require specialized equipment and expertise.
Simplifying Detection and Diagnosis
BioGX’s Candida auris reagents and PCR mix represent a game-changer for healthcare professionals combating this elusive pathogen. By streamlining the process in a single lyophilized tube, BioGX eliminates the need for complex workflows and minimizes the risk of contamination. CustomizedThis ready-to-use format not only saves time but also enhances reliability, ensuring prompt and accurate identification of C. auris infections.
Conclusion: Navigating the Landscape of Candida auris Detection
In the battle against Candida auris, the choice of detection method can significantly impact clinical patient outcomes and infection control efforts. PCR stands out as a gold standard for its exceptional sensitivity, specificity, and rapid turnaround time.
However, a multifaceted approach that incorporates culture-based methods, AST, and complementary techniques like MALDI-TOF MS can provide a comprehensive understanding of C. auris infections and guide tailored treatment strategies.
Disclaimer: Information in the blog is provided to educate and propagate general awareness and not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of information presented in the blog.
https://www.biogx.com/wp-content/uploads/2024/04/candida_blog_img.jpg400495Zeeshan Khanhttps://biogx.com/wp-content/uploads/2021/07/BioGX-New-Logo-final.pngZeeshan Khan2024-04-22 04:50:332024-04-23 06:06:41Candida auris Detection: Unraveling the Pros and Cons of PCR and Other Testing Methods
When diagnosing infectious diseases, precision and efficiency are critical. Pneumocystis pneumonia (PCP), caused by the fungus Pneumocystis jirovecii, poses a significant threat to immunocompromised individuals, including those living with HIV/AIDS, organ transplant recipients, and patients undergoing chemotherapy. Rapid and accurate detection of this opportunistic pathogen is crucial for timely intervention and patient management.
Unraveling the Mystery of Pneumocystis
Pneumocystis jirovecii has long puzzled researchers and clinicians due to its atypical characteristics and elusive detection nature. Traditional diagnostic methods, such as culture and immunoassays, have been inadequate. Culturing Pneumocystis is challenging and time-consuming and immunoassays may lack sensitivity and specificity; both leading to false-negative results.
In contrast, polymerase chain reaction (PCR) testing is a superior alternative, with the ability to detect ultra-low levels of pneumocystis DNA, providing improved sensitivity and specificity.
The Power of Multiplex Real-Time PCR
PCR has emerged as the gold standard for detecting infectious agents, including viruses, bacteria, and fungi. This molecular technique amplifies specific DNA sequences, enabling the detection of pathogens even at low concentrations. BioGX’s Sample-Ready™ Open System PCR Reagents offers a comprehensive solution for Pneumocystis detection.
Provided in a convenient lyophilized format, its multiplexing real-time PCR capability enables simultaneous detection of Pneumocystis jirovecii DNA (msg gene1) and Drosophila DNA (Internal Amplification Control/Sample Processing Control). This innovative approach enhances testing efficiency and the internal QC ensures accurate results.
Advantages Over Conventional Methods
Polymerase Chain Reaction (PCR) is often considered the preferred method for detecting Pneumocystis jirovecii, the organism responsible for Pneumocystis pneumonia (PCP) due to:
1. Sensitivity: PCR amplifies DNA sequences specific to Pneumocystis jirovecii to detect small amounts of the organism’s DNA.
2. Specificity: Assay designed to target unique DNA sequences of Pneumocystis jirovecii, minimizing the risk of false-positive results.
3. Rapid results: PCR assays typically have shorter result generation times than culture-based methods, providing more timely results.
4. Flexibility: PCR testing can be performed on numerous biological specimens including blood, saliva, urine and sputum.
Immunoassays detect antibodies or antigens produced in response to Pneumocystis infection, but they may lack sensitivity, especially in immunocompromised patients.
Culture-based methods involve growing the organism in culture media, but Pneumocystis can be difficult to cultivate, contributing to lower sensitivity.
Conclusion
In the battle against Pneumocystis pneumonia, accurate and timely information is critical. Multiplex real-time PCR testing offers a comprehensive solution that combines sensitivity, specificity, and efficiency for healthcare professionals to confidently identify Pneumocystis jirovecii DNA.
Disclaimer: Information in the blog is provided to educate and propagate general awareness and not intended to make any recommendations for diagnosis or treatment of a disease. The reader is encouraged to independently verify the accuracy of information presented in the blog.
Robert Martinez, Ph.D, VP, Business Development & Scientific Affairs
Dr. Martinez joined BioGX in 2015. Dr. Martinez is responsible for Business Development and Scientific Affairs, expanding our portfolio of IVD products, managing the global technical support efforts of all molecular diagnostic products, and manages a team of scientists responsible for product and technology innovation in conjunction with existing corporate partnerships. Dr. Martinez has over 20 years of experience in molecular biology. Prior to joining BioGX, Dr. Martinez held research positions focusing on cancer cell biology at Albany Medical College, microbial community dynamics at The Georgia Institute of Technology and microbial physiology at The University of Alabama. Dr. Martinez holds a BA in Biology from Boston University and a Ph.D. in Microbiology from The Georgia Institute of Technology.
Hardy Green, Controller
Mr. Green joined BioGX as a Controller in 2020. He has 30+ years of leadership experience in accounting across diverse industries, including healthcare, water utility management, waste management, mineral extraction, and cash handling. At BioGX, Mr. Green is responsible for managing finance and purchasing departments. He has a BS degree in Accounting from The University of Alabama, and he is a Certified Public Accountant (inactive).
Shazi Iqbal, Ph.D, Venture Partner
Dr. Shazi Iqbal is a Co-Founder of BioGX and served as its CEO from 2011 to June 2024. Now, as a Venture Partner, he leads M&A and strategic investment opportunities to enable innovation partnerships. Dr. Iqbal has over 25+ years of experience in building healthcare startups into profitable growth companies. He holds a Ph.D. in Biology (Neuroscience), two M.S. degrees in Biochemistry & Biotechnology, and several patents and publications.
Staphylococcus epidermidis group (S. hominis ,S. simulans, S.warneri, S. epidermidis, S. haemolyticus)
Staphylococcus haemolyticus
Staphylococcus lugdunensis
Staphylococcus saprophyticus
Streptococcus agalactiae
Streptococcus pyogenes
Treponema pallidum
Ureaplasma parvum
Ureaplasma urealyticum
HSV-1
HSV-2
Fungi
Candida albicans
Candida auris
Candida glabrata
Candida krusei
Candida parapsilosis
Candida spp. (C.albicans, C. auris, C. dubliniensis, C. glabrata, C. krusei, C.lusitaniae, C. parapsilosis, C. tropicalis)
Candida tropicalis
Protozoan
Trichomonas vaginalis
Antimicrobial Resistance
GES
KPC
mcr-1
mecA
mecC
NDM
OXA-48
van B
vanA
vanC1/C2/C3
VIM
SAMPLE-TO-ANSWER IN 3 EASY STEPS!
Shahin Iqbal, Ph.D, President and COO
Dr. Shahin Iqbal is the President and Chief Operating Officer at BioGX. He has over 25 years of experience in clinical molecular diagnostics. Before joining BioGX, Dr. Iqbal led the Abbott Diagnostics Global Service & Support specifically for informatics, core lab automation, immunoassay and clinical chemistry systems. He was also responsible for design and development of FISH automation systems at Abbott Molecular. He is the recipient of the President awards and multiple service & innovation awards at Abbott. Dr. Iqbal holds multiple patents on optical sensors, automation systems development, RFID applications and robotics for system dispensing. Prior to joining Abbott, Dr. Iqbal was Head of operations, quality & regulatory, systems development and manufacturing of IHC systems at BioGenex in California. Dr. Iqbal has an MBA and Ph.D as well as a Masters in Electrical Engineering degree from the University of Texas in San Antonio.
George Blackstone, VP, Research & Development
Mr. Blackstone joined BioGX in 2007. He has served at BioGX in various senior R&D and quality management roles prior to his current position as VP of Research & Development. Mr. Blackstone has designed and directed the development of over 100 multiplex real time PCR products in the fields of food safety, water quality, pharma QC, and clinical diagnostics. Mr. Blackstone previously served for eight years at the US Food and Drug Administration and as a Commissioned Research Officer in the US Public Health Service Commissioned Corps where he achieved the rank of Lieutenant Commander. George Blackstone received his Master of Science degree from Louisiana State University.
Christopher Hughes, VP, Operations & QRA
Mr. Hughes joined BioGX in 2015. Prior to joining BioGX, Mr. Hughes led efforts for a diverse range of companies with the development and implementation of certified quality management systems ranging from data storage devices with SONY Corporation, security & detention devices with Norment Security Group, textile manufacturing with Twitchell Corporation, combat vehicle manufacturing with General Dynamics, and therapeutic medical devices with Steris Corporation. Christopher has a BSE from Auburn University and an MBA from Troy State University.
Please read this
If you are contacting us because you have received a phone call offering genetic testing services, with the caller requesting personal health information and personal identification numbers (such as Medicare Card numbers), please know that we are NOT responsible for such calls.
We, BioGX, Inc., (registered trademark “BioGX”) with offices in Birmingham, AL, Dallas, TX, and Amsterdam, The Netherlands, are a diagnostic test manufacturer and not a testing laboratory, and we are not in any way affiliated with such callers. We do not know who is making these calls.
UNDER NO CIRCUMSTANCES BIOGX WOULD EVER CONTACT INDIVIDUALS TO OFFER GENETIC TESTING SERVICES OR REQUEST PERSONAL INFORMATION OF ANY KIND.
This Fact Sheet informs you of the significant known and potential risks and benefits of the use of the BioGX Xfree™ COVID-19 Direct RT-PCR.
The BioGX Xfree™ COVID-19 Direct RT-PCR is validated for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
Michael Vickery, PhD, EVP, Chief Scientific Officer
Dr. Vickery founded BioGX in 2007 and served as President and CEO until 2011. Prior to founding BioGX, Dr. Vickery worked in sales and as a technical consultant at Cepheid. Prior to Cepheid, Dr. Vickery worked at the FDA as a University of Maryland JIFSAN postdoctoral fellow at the University of Maryland, and later served as the Lead for Molecular Methods Development at the U.S. FDA Gulf Coast Seafood Laboratory. He holds multiple patents in biotechnology, has authored or co-authored many publications, and has extensive experience in gene expression analysis, and in the design and development of rapid multiplex molecular tests for microbial and viral detection. Dr. Vickery holds a B.S. degree in Physics and both M.S. and Ph.D. degrees in Biology (molecular biology and molecular genetics focus – both prokaryotic and eukaryotic). Prior to entering graduate school, Dr. Vickery worked as an executive in the lowbed trailer industry for almost 10 years, pioneering the sale of American made heavy equipment transport trailers into China (ROC) and Japan during his tenure in the industry, and resupplying the oilfields of Kuwait with specialized trailers after the Gulf War.
