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BD Gets CE Mark for Point-of-Care Coronavirus Antigen Test

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Becton, Dickinson and Company (BDX - Free Report) — also popularly known as BD — recently received CE mark for its 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.

For investors’ note, the BD Veritor Plus System for rapid detection of SARS-CoV-2 assay, although CE marked, has not been cleared or approved by the FDA. The test has been authorized by the FDA under an Emergency Use Authorization for utilization by authorized laboratories, only to detect proteins from SARS-CoV-2 and not for any other viruses or pathogens.

This development is likely to boost BD’s Life Sciences segment, while enhancing the COVID-19 diagnostic testing portfolio.

More on the News

The BD Veritor Plus System is a little bigger than a mobile phone and provides an easy-to-use workflow, which makes it an ideal solution for point-of-care settings. Additionally, it provides traceability and reporting capabilities to customers via the optional BD Synapsys informatics solution.

The new test, which delivers results in 15 minutes, utilizes the BD Veritor Plus System that has already been in use throughout Europe to test for conditions such as Group A Strep, influenza A+B and Respiratory Syncytial Virus.



The European Centre for Disease Prevention and Control released guidance that all patients with acute respiratory symptoms should be tested for both SARS-CoV-2 and influenza A+B in parallel during the flu season. By using the same platform, the BD Veritor Plus System can test for both infections.

The addition of this portable, point-of-care test can help healthcare providers and patients to combat against additional waves of COVID-19. It is important to mention here that BD is leveraging the global manufacturing network and scale to produce 8 million SARS-CoV-2 antigen tests per month by October and anticipates providing 12 million tests per month by March 2021.

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.

Notable Development

In July, the company formed a strategic, public-private partnership with the Biomedical Advanced Research and Development Authority, which is part of the U.S. Health and Human Services Office of the Assistant Secretary for Preparedness and Response. The primary objective of this collaboration is to create new manufacturing lines for injection devices that will offer priority access to the U.S. government for hundreds of millions of syringes and needles to address the current and future pandemic vaccination efforts.

Price Performance

Over the past year, shares of this Zacks Rank #3 (Hold) company have lost 6.8% against the industry’s 11% rally.

Stocks to Consider

Some better-ranked stocks from the broader medical space include Biolase, Inc. (BIOL - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and NextGen Healthcare, Inc. , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Biolase has a projected long-term earnings growth rate of 15%.

Thermo Fisher has an estimated long-term earnings growth rate of 15%.

NextGen has a projected long-term earnings growth rate of 8%.

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