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BD's (BDX) Latest Monkeypox PCR Assay Commercially Available

Becton, Dickinson and Company BDX, popularly known as BD, and CerTest Biotec recently announced that their newly developed molecular polymerase chain reaction (PCR) assay for monkeypox virus — CerTest VIASURE Monkeypox molecular research use only (RUO) assay — is now commercially available worldwide, including the United States. The PCR assay is for RUO applications by laboratories.

Both players leveraged the BD MAX System open architecture reagent suite to develop the molecular RUO PCR assay. Also, BD is working toward submitting a clinical test for monkeypox virus for emergency used authorization as early as possible, based on the FDA’s guidance issued on Sep 7.

The latest launch is expected to solidify BD’s foothold in the global Molecular Diagnostics business, thereby boosting its overall Life Sciences segment.

Significance of the Launch

Per BD’s management, the latest molecular RUO PCR assay is expected to aid in better understanding and tracking the monkeypox outbreak. The company’s installed base of BD MAX System experienced a solid surge courtesy of the COVID-19 pandemic, which will likely provide more access to the unique, open-architecture system that enables rapid response to emerging health threats like monkeypox.

CerTest Biotec’s management feels that the new test will likely boost capacity for monkeypox research and surveillance of the global health emergency. Thus, the value of the BD MAX open systems architecture and its ability to speed up research and development continues to play a vital role.

Industry Prospects

Per a report by MarketsandMarkets, the global molecular diagnostics market is anticipated to reach $30.2 billion by 2027 from $23.2 billion in 2022 at a CAGR of 5.4%. Factors like the emergence of new viruses, technological advancements in molecular diagnostics and the growing awareness of early disease diagnosis are likely to drive the market.

Given the market potential, the latest launch is expected to significantly strengthen BD’s business worldwide.

Notable Developments in Life Sciences Arm

Last month, BD launched BD Research Cloud, a cloud-based software solution designed to streamline the flow cytometry workflow to enable higher quality experiments with faster time to insight for scientists working across a range of disciplines, including immunology and oncology, among others.

In August, BD announced a worldwide commercial collaboration agreement with Accelerate Diagnostics, Inc. Per the agreement terms, BD will offer Accelerate Diagnostics’ rapid testing solution for antibiotic resistance and susceptibility, offering results in a few hours.

The same month, BD entered into a collaboration with Laboratory Corporation of America Holdings or LabCorp. The tie-up was aimed at creating a framework to develop, manufacture, market and commercialize flow cytometry-based companion diagnostics intended to match patients’ best available treatments for cancer and other diseases.

Comparison With Peers

Last month, BD’s peer Thermo Fisher Scientific Inc. TMO certified the Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System to meet new In Vitro Medical Devices Regulation requirements.

The same month, Thermo Fisher opened a new biomanufacturing facility in Chelmsford, MA. TMO’s latest facility is expected to help meet the growing demand for the biologic materials needed to produce vaccines and breakthrough therapies for cancer and other diseases.

Another peer of BD, Bio-Rad Laboratories, Inc. BIO, reached an agreement in August to acquire all of the outstanding shares of Curiosity Diagnostics, Sp. Z. o. o. from Warsaw, Poland-based Scope Fluidics, S.A.

In July, Bio-Rad announced its second-quarter 2022 results, registering an uptick in quarterly sales at a constant exchange rate (CER) on a year-over-year basis. BIO also registered an improvement in its second-quarter 2022 revenues, excluding COVID-related sales, at CER.

Another renowned name in the PCR space and BD’s peer, Qiagen N.V. QGEN, announced new additions to its comprehensive NeuMoDx assay menu for organ transplant-associated viruses last month. The new assays for the identification and quantification of the Epstein-Barr virus and the human herpesvirus 6 have received CE-IVD certification for the European Union and other countries that accept this marking.

In August, Qiagen announced the launch of the QIAstat-Dx Viral Vesicular Panel RUO, the first syndromic test to differentiate between monkeypox and five other pathogens which cause similar symptoms. The new panel, currently for RUO, comes in cartridge form to run on QGEN’s QIAstat-Dx automated syndromic testing devices.


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