Credo Diagnostics Biomedical Pte. Ltd

Singapore, March 2^nd, 2023 – Update on Detection of the Influenza A subtypes

Credo Diagnostics Biomedical Pte. Ltd. is committed to the post-market monitoring of the reliability of our assays. We have performed nucleotide analysis using the BLASTn method, comparing primers and probes of the assays involving Influenza A virus detection to the sequences of Influenza A H3N2, H1N1, H5N1, and H7N9 subtypes listed in GISAID, NCBI, and BV-BRC up until 31st January 2023.

Our analysis has confirmed that our assays maintain their stated level of performance.

*The Influenza A virus detection assays include:
． VitaPCR™ Influenza/SARS-CoV-2 (Flu/SC2) Assay (PCRAE0128)
． VitaPCR™ Flu/RSV Assay (PCRAE0106)
． VitaPCR™ Flu A&B Assay (PCRAE0103)

For more information, contact us at service@credodxbiomed.com.

About Credo Diagnostics Biomedical Pte. Ltd.

Credo Diagnostics develops and manufactures innovative, easy-to-use, and rapid molecular diagnostic solutions for Point-of-Care (POC) applications at affordable costs without compromising accuracy and speed in the areas of Human Health. Leveraging solid and established science, combined with efficient integration and strategic innovation, Credo Diagnostics Biomedical provides advanced medical technologies for all.

Singapore, February 9, 2023 – Detection of the latest SARS-CoV-2 Variant Strain

In response to the rise of new Covid-19 variants, Credo Diagnostics Biomedical Pte Ltd continues to ensure the effectiveness of our assays using BLASTn analysis. (with the oligonucleotide primers and probes of the assays involving SARS-CoV-2 detection) against the sequences listed in GISAID from September 1^st, 2022 to January 31^st, 2023.

We are pleased to announce that our VitaPCR™ system is capable of detecting the Omicron XBB.1.5 subvariant, and our analysis has confirmed that the performance of our SARS-CoV-2 RNA detection assays* is not impacted by the Omicron subvariant, XBB.1.5.

*The SARS-CoV-2 RNA detection assays include:
． VitaPCR™ Influenza/SARS-CoV-2 (Flu/SC2) Assay (PCRAE0128)
． VitaPCR™ SARS-CoV-2 Assay (PCRAE0114)
． VitaPCR™ SARS-CoV-2 Gen 2 Assay (PCRAE0120)

For more information, contact us at service@credodxbiomed.com.

About Credo Diagnostics Biomedical Pte. Ltd.

Credo Diagnostics develops and manufactures innovative, easy-to-use, and rapid molecular diagnostic solutions for Point-of-Care (POC) applications at affordable costs without compromising accuracy and speed in the areas of Human Health. Leveraging solid and established science, combined with efficient integration and strategic innovation, Credo Diagnostics Biomedical provides advanced medical technologies for all.

13 January 2023 - BIOSYNEX (ISIN : FR0011005933, Mnémonique :ALBIO), a major player in public health, announces the extension of its partnership with the Singaporean company Credo Diagnostics Biomedical Pte Ltd (“Credo Diagnostics”).

The collaboration between the two companies had started at the beginning of the Covid-19 health crisis in March 2020, which eventually led to an agreement to distribute VitaPCR^TM systems in France, Belgium, Switzerland and Luxembourg.

Founded in 2011, Credo Diagnostics launched the VitaPCR^TM in 2019, a revolutionary molecular biology platform capable of detecting infectious pathogens (including the SARS-CoV-2 responsible for Covid-19, influenza and RSV viruses) by Polymerase Chain Reaction (PCR) methodology in only 20 minutes.  With its ease of use, VitaPCR^TM contributes significantly to the decentralization of tests from centralized labs to private medical laboratories, general hospitals or even directly by nursing staff in clinical departments.

In more than two years of partnership, BIOSYNEX has successfully implemented the VitaPCR^TM solution in more than 300 sites in France, including private clinical laboratories, hospitals, and remote sites (airports, cruise ships, companies).

BIOSYNEX and Credo Diagnostics have recently strengthened their collaboration by signing an exclusivity agreement for an extended territory including the United Kingdom. Thanks to the acquisition of BHR in May 2022, BIOSYNEX now has a direct sales force in the United Kingdom and anticipates a significant deployment of the VitaPCR^TM systems in this country which is at the forefront of Point-of-Care diagnostic solutions.

In addition, Credo Diagnostics will be releasing a next generation rapid PCR platform, VitaSIRO solo^TM based on microfluidic technology that simplifies the entire procedure. The multiplexing capability of the new platform enables the simultaneous viral detection of influenza, SARS-CoV-2 and Respiratory Syncytial Virus (RSV) that cause bronchiolitis. This new respiratory assay was developed with the intention of meeting the diagnostic demand linked to winter respiratory epidemics due to multiple viruses and will strengthen the diagnostics portfolio of Credo Diagnostics. Furthermore, new applications are being developed on this platform and will enable BIOSYNEX to expand its solution offer to existing customers as well as future prospects.

Larry Abensur, Chaiman and CEO of BIOSYNEX: “Our collaboration with Credo Diagnostics has greatly contributed to making BIOSYNEX a key player in Covid-19 diagnostics in France. This new agreement is a major step in our partnership because it opens up important commercial development opportunities in this post pandemic period by giving us access to new applications and new territories.”

Dr. Winston Wong Jr., Chairman and CEO of Credo Diagnostics: “We are happy with the performances of BIOSYNEX not only in the areas of the distribution of our products, but the support in other areas of Clinical Performance Studies and generation of scientific reports for our VitaPCR™ platforms. I am looking forward to the introduction of our new VitaSIRO solo™ platforms to their distribution network.”