NEWS

    2022
    11-01
    VitaPCR™ SARS-CoV-2 Gen 2 Assay receives approval for continued distribution in the United Kingdom

    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.

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    2022
    10-20
    Update on Detection of the latest SARS-CoV-2 Variant Strain

    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.

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    2022
    10-03
    Detection of Influenza A H3N2 virus

    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.

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    2022
    07-26
    Credo Diagnostics’ booth at AACC 2022 has officially opened.

    Singapore, July 26, 2022 – Credo Diagnostics presents at AACC, Chicago, IL, USA, on July 26 - 28, 2022.

     

    At the 2019 AACC in Anaheim, CA, Booth #4339, Credo Diagnostics launched our VitaPCR™ Instrument and our first VitaPCR™ Influenza A&B Assay.

     

    After one year, our product lines include the VitaPCR™ SARS-CoV-2 Gen 2 Assay, VitaPCR™ Influenza/SARS-CoV-2 Assay, VitaPCR™ Influenza/RSV Assay, and VitaPCR™ Strep A Assay.
     
    For AACC 2022 in Chicago, Credo Diagnostics are happy to announce our participation, and importantly, will introduce our new molecular diagnostic platform – VitaSIRO solo™, and share what we have done since the onset of COVID-19 to help countries provide VitaPCR™ machines.

     

    “Today, it is a great honour to see our solutions accepted and requested by users worldwide. We strive to provide the best solutions to our customers continually and we will never stop innovating."
     

    Come visit us at Booth #4456 to see for yourself.

     

    Credo Diagnostics, “Advanced Medical Technology For All”

     

     Booth #4456, 2022 AACC Annual Scientific Meeting & Clinical Lab Expo

     

    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.

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    2022
    07-01
    Credo Diagnostics will be present at the AACC event in Chicago, USA.

    Singapore, July 1, 2022 - Credo Diagnostics is pleased to announce our participation at the coming 2022 AACC Annual Scientific Meeting & Clinical Lab Expo event from July 26 - 28, 2022 in Chicago, IL, USA.

     

    The AACC Annual Scientific Meeting & Clinical Lab Expo is the world’s leading global professional gathering for clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of breaking science in laboratory medicine. It will showcase the cutting-edge science and technology changing the future of laboratory medicine.

     

    At the 2019 AACC in Anaheim, CA, Booth #4339, Credo Diagnostics launched the VitaPCR™ Instrument and the first VitaPCR™ Influenza A&B Assay.

     

    Today, Credo Diagnostics’ product lines include the VitaPCR™ SARS-CoV-2 Gen 2 Assay, VitaPCR™ Influenza/SARS-CoV-2 Assay, VitaPCR™ Influenza/RSV Assay, and VitaPCR™ Strep A Assay.

     

    For the coming 2022 AACC in Chicago, Credo Diagnostics are happy to announce our participation, and importantly, Credo Diagnostics will reveal the arrival of an exciting new platform and a whole series of new Assays.

     

    “Today, it is a great honour to see our solutions accepted and requested by users around the world. We strive to continually provide the best solutions to our customers, and we will never stop innovating." said Dr. Wong Jr. Winston, Chairman, and CEO of Credo Diagnostics Biomedical.

     

    Come visit Credo Diagnostics at Booth #4456 to see for yourself.

     

    Credo Diagnostics, “Advanced Medical Technology For All”

     

    About Credo Diagnostics Biomedical Pte. Ltd.

    Credo Diagnostics Biomedical 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.

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    2022
    05-31
    VitaPCR™ SARS-CoV-2 RNA detection Assay can correctly detect Omicron sub-lineages BA.4 and BA.5

    Singapore, May 31, 2022 – In response to the new Omicron variant (also known as B.1.1.529), 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 on May 25th, 2022.

     

    According to our analysis, we confirm that our SARS-CoV-2 RNA detection assay* can correctly detect the new Omicron strain, including B.1.1.529 BA.1, BA.2, BA.4, and BA.5.

     

    Meanwhile. we continue to affirm that our SARS-CoV-2 RNA detection assay is still capable of detecting the following earlier variant strains correctly

     

    Another circulating Variant of Concern (VOC):

    Delta variant: known as B.1.617.2

     

    Previously circulating Variants of Concern (VOC):

    . Alpha variant: known as B.1.1.7

    . Beta variant: known as B.1.351

    . Gamma variant: known as P.1

    Previously circulating Variants of Interest (VOI)

    Lambda variant: known as C.37

    Mu variant: known as B.1.621

    Eta variant: known as B.1.525

    Iota variant: known as B.1.526

    Kappa variant: known as B.1.617.1

    Zeta variant: known as P.2

    Epsilon variant: known as B.1.427/B.1.429

    Indian variant: known as B.1.617.3

     

     

    * The SARS-CoV-2 RNA detection assays include:

       VitaPCR™ Influenza/SARS-CoV-2 (Flu/SC2) Assay (PCRAE0128)

       VitaPCR™ SARS-CoV-2 Gen2 Assay (PCRAE0120)

       VitaPCR™ SARS-CoV-2 Assay (PCRAE0114)

     


    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 Human Health. Leveraging solid and established science, combined with efficient integration and strategic innovation, Credo Diagnostics Biomedical provides advanced medical technologies for all.

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