Credo Diagnostics Biomedical Pte. Ltd

Singapore, November 1, 2022 – VitaPCR™ SARS-CoV-2 Gen 2 Assay receives approval for continued distribution in the United Kingdom

On 28 October 2022, Credo Diagnostics Biomedical received confirmation from the UK Health Security Agency that the VitaPCR™ SARS-CoV-2 Gen 2 Assay has been approved under the requirements set out in The Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.

VitaPCR™ SARS-CoV-2 Gen 2 Assay is a rapid molecular in-vitro diagnostic solution, using real-time reverse transcription polymerase chain reaction (rRT-PCR) amplification technology for the qualitative detection of SARS-CoV-2 in patients’ nasopharyngeal swabs.

VitaPCR™ SARS-CoV-2 Gen 2 system is easy to use and portable to deploy anywhere. This solution delivers accurate results in 20 minutes, allowing healthcare professionals to provide patients with the right course of treatment in a timely manner.

Dr. Wong Jr. Winston, Chairman and CEO of Credo Diagnostics Biomedical, said, “We are honored to receive the UK CTDA approval for our VitaPCR™ SARS-CoV-Gen 2 Assay. This significant milestone further reinforces our commitment to our mission of providing advanced medical technology for all. This accomplishment could not have been possible without the hard work and dedication of the team at Credo Diagnostics Biomedical. Together with our distribution network for VitaPCR™, we are ready for expansion into the UK market, bringing accessible diagnostics solutions to improve lives.”

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, October 20, 2022 – Update on Detection of the latest SARS-CoV-2 Variant Strain

In response to the emergence of new COVID-19 variants, and to mitigate any potential risks that these variants may have on our assay performance, we, Credo Diagnostics Biomedical Pte Ltd, have performed the BLASTn analysis (with the oligonucleotide primers and probes of the assays involving SARS-CoV-2 detection) against the sequences listed in GISAID from September 1st to October 17th, 2022.

Our analysis has confirmed that the performance of our SARS-CoV-2 RNA detection assays* is not impacted by the Omicron subvariants, including B.1.1.529 BA.1, BA.2, BA.4, and BA.5 along with the new Omicron subvariants stated below:
． XBB - a hybrid of two BA.2 variants
． BQ.1.1 and BF.7 - the BA.5 subvariants

Meanwhile, we continue to affirm that our SARS-CoV-2 RNA detection assay is still capable of detecting the following previously circulating Variants of Concern (VOCs):
． Alpha variant - known as B.1.1.7
． Beta variant - known as B.1.351
． Gamma variant - known as P.1
． Delta variant - known as B.1.617.2

*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)

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, October 3, 2022 – Detection of Influenza A H3N2 virus

In response to the emergence of variants of influenza A H3N2 viruses, and to mitigate any potential risks that these variants may have on our assay performance, we, Credo Diagnostics Biomedical, have performed the BLASTn analysis (with the oligonucleotide primers and probes of the assays involving Influenza A virus detection) against the sequences of eight circulating influenza A variants (seven variants belong to clade 3C.2a1b.2a.2 and one variant belongs to clade 3C.2a1b.1a) listed in the Danish published study.¹

According to our analysis, we hereby confirm that all our Influenza A detection assays, including VitaPCR™ Flu A&B assay, VitaPCR™ Flu/RSV assay, and VitaPCR™ Influenza/SARS-CoV-2 (Flu/SC2) assay, are capable of detecting these eight variants correctly.

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.