Cepheid, BioGX to Jointly Develop Monkeypox PCR Test for GeneXpert System

Cepheid and BioGX announced on Monday a collaboration to develop a monkeypox assay on the GeneXpert system. Financial and other terms of the deal were not disclosed.

The assay will be delivered as part of Cepheid’s FleXible Cartridge program for the GeneXpert, a system that has an installed base of more than 40,000 instruments in 180 countries, the firms noted in a statement.

“Our FleXible Cartridge program gives Cepheid the ability to work with external partners to develop accurate tests quickly when the need arises,” said David Persing, Cepheid’s executive VP and CSO, in a statement.  Read Full Article

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May 2022 Update: BioGX in silico analysis of SARS-CoV-2 Variants of Concern

BioGX continuously monitors the evolution of COVID-19 variants to ensure our market leading SARS-CoV-2 RT-PCR tests will continue to detect emerging variants without impacting performance.


BioGX has completed in-silico analysis of over 2.5 million SARS-CoV-2 genome sequences available as of May 31, 2022. Sequence analysis compared the available Omicron genomes against the SARS-CoV-2 nucleocapsid (N-gene) and envelope (E-gene) , targeted by BioGX products. In-silico analysis and empirical testing of the Omicron variant confirmed the gene mutations will not affect the performance of the BioGX portfolio of SARS-CoV-2 products.


BioGX portfolio of SARS-CoV-2 products

  1. BioGX Xfree™ COVID-19 Direct RT-PCR – FDA EUA
  2. BD BioGX SARS-CoV-2 Reagents for BD MAX™ System
  3. BioGX SARS-CoV-2 HMP – N1, N2 & RNase P Multiplex
  4. BioGX COVID-19, Flu A, Flu B, RSV RT-PCR for BD MAX™
  5. BioGX SARS-CoV-2 N1, N2, E-gene (RUO)
  6. BioGX SARS-CoV-2 N1, Flu A, Flu B, RSV A/B (RUO)


U.S. CDC and WHO Variants of Concern*  % Clades detected by targets
WHO designation Pango lineage GISAID


Nextstrain clade Spike Protein 

(a.a. changes)

Region Initially Documented (Date) No. Sequences Analyzed 


N1 N2 E
Alpha B.1.1.7


GRY 20I (V1) 69del, 70del, 144del, (E484K**),(S494P**),N501Y, A570D, D614G, P681H, T716I, S982A, D1118H, (K1191N**) United Kingdom (SEP 2020) 430,915


Beta B.1.351



GH/501Y.V2 20H (V2) L18F, D80A, D215G, 241del, 242del, 243del, K417N, E484K, N501Y, D614G, A701V South Africa (MAY 2020) 26,248


Gamma P.1


GR/501Y.V3 20J (V3) 681H,L18F, T20N, P26S, D138Y, R190S, K417T, E484K, N501Y, D614G, H655Y, T1027I Brazil

(NOV 2020)



Delta B.1.617.2


G/478K.V1 21A, 21I, 21J 417N, T19R, (V70F**), T95I, G142D, E156-, F157-, R158G, (A222V**), (W258L**), (K417N**), L452R, T478K, D614G, P681R, D950N India

(OCT 2020)



Omicron B.1.529


GR/484A 21K, 21L, 21M +R346K Multiple Countries

(NOV 2021)





*Variants of concern being monitored by US CDC and WHO

**Present in a subset of sequences

BA.1, BA.2, BA.3, BA.4, BA.5, and XE are sub-lineages of Omicron variant

Bosch Receives CE-IVD Mark for STI Test, developed in partnership with BioGX

Bosch Healthcare Solutions has received CE-label for the new Vivalytic MG, MH, UP/UU, developed in partnership with BioGX.

The multiplexed real-time PCR-based assay can detect four sexually transmitted infections involving Mycoplasma genitaliumMycoplasma hominisUreaplasma parvum, and Ureaplasma urealyticum.

The assay has a turnaround time of about an hour, and the company said it is positioning it for adoption at the point of care, such as in doctor’s offices and clinics. Conventional approaches rely on culturing methods and can take up to days or even months to produce a result in the case of M. hominis.

Waiblingen, Germany-based Bosch, a subsidiary of the Bosch Group, has worked with Birmingham, Alabama-based BioGX to develop the test. The partners announced an agreement in 2020, under which BioGX would develop, produce, and supply reagents for Bosch’s Vivalytic cartridges. BioGX also agreed to provide custom reagent manufacturing services for Vivalytic open system users at that time.

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