BD's (BDX) COVID-19 Real-Time PCR Detection Kit Gets CE Mark

Becton, Dickinson and Company BDX, also known as BD, and CerTest Biotec recently announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX System has attained CE mark approval.

Notably, CerTest Biotec is a European company specializing in the development and manufacturing of in vitro diagnostic medical devices.

This development is expected to boost BD Life Sciences segment.

More on the Detection Kit

This kit enables BD MAX System users to run a single module that tests for COVID-19 and Influenza (Flu), along with Respiratory Syncytial Virus (“RSV”) at once.

The new test kit will offer rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B, and RSV A and B.

The BD MAX System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can generate results in two-three hours and is equipped to analyze hundreds of samples over a span of 24 hours.

By utilizing its wide installed base and the efficacy of the BD MAX System, this test will significantly improve capacity for SARS-CoV-2 and Influenza testing, thereby helping clinicians to quickly diagnose patients and help curb the spread of COVID-19. In conjunction with CerTest, BD can now offer its customer base in Europe with a complete solution for COVID-19 diagnostics during the winter season.

For investors’ notice, the VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX System and VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX System are sold via BD's network and not available for sale within the United States.

Market Prospects

Per a report published on Grand View Research, the global molecular diagnostics market was valued at $9.2 billion in 2019 and is expected to reach $18.2 billion by 2027, witnessing a CAGR of 9% between 2020 and 2027. Factors like technological advancements in molecular diagnostics and the rising prevalence of infectious diseases are likely to drive the market. Hence, the latest development has been a well-timed one for BD.

Recent Development

In September, BD received CE mark for the rapid, point-of-care, SARS-CoV-2 antigen test for utilization on the BD Veritor Plus System. The new test brings in substantial improvement in turnaround time for COVID-19 diagnostics as it offers real-time results and helps to make decisions while the patient is still onsite. Notably, the company anticipates this new assay to be commercially available by October-end for countries in Europe that recognize the CE mark.

There are other players in the MedTech space that have made significant progress in the field of diagnostic testing and continue to do so.

In September, Quest Diagnostics DGX launched three-in-one single swab tests. According to the company, nearly 20 viral and bacterial infections can be identified from a single swab, thereby reducing time for diagnosis and treatment.

In August, Abbott Laboratories ABT made a path-breaking development in this space with the launch of the $5 rapid antigen test, BinaxNOW COVID-19 Ag Card. This cost-effective credit card sized pocket-friendly test uses Abbott’s lateral flow technology and provides results in as less as 15 minutes.

In August, Fluidigm Corporation FLDM received the FDA’s EUA for the Advanta Dx SARS-CoV-2 RT-PCR Assay, an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus. It is designed to be run on the Fluidigm Biomark HD microfluidics platform.

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