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BD (BDX) Gets EUA, CE Mark for New Molecular Diagnostic Test

Becton, Dickinson and Company BDX, also popularly known as BD, recently announced the receipt of Emergency Use Authorization (EUA) from the FDA for a new combination molecular diagnostic test to detect both SARS-CoV-2 and Influenza A+B in a single test that can generate results in two to three hours. The new test has also attained CE mark approval.

The BD SARS-CoV-2/Flu for BD MAX System kits can now be ordered in the United States and Europe. Notably, the test is the newest addition to the company's comprehensive COVID-19 diagnostics response.

This recent FDA authorization is likely to boost BD’s Lifesciences segment.

More About BD’s New Molecular Diagnostic Test

It is worth mentioning here that the BD MAX System is a molecular diagnostic platform already utilized by thousands of laboratories globally, wherein each unit has the capability of analyzing hundreds of samples daily.

Notably, the BD SARS-CoV-2/Flu assay, run on the BD MAX System, helps to differentiate between SARS-CoV-2 and Influenza A+B and delivers a positive or negative result for each virus using a single specimen.

Healthcare professionals will benefit from new diagnostic solutions for COVID-19 and Flu in the form of timely diagnosis. Further, these solutions might contribute to rapid and clinically-appropriate patient management and treatment. The latest test has the ability to address SARS-CoV-2 variants, including those from the U.K. and South Africa, thereby helping health care practitioners detect and contain these new strains.

Notable Developments

In January 2021, BD announced a new clinical study, which demonstrates the company’s antigen test being more selective than polymerase chain reaction (PCR) molecular tests when it comes to detecting people who are contagious and can spread the COVID-19 virus. Additionally, the low cost and scalability of antigen-based testing is an important tool to curb COVID-19 community transmission.

In October 2020, BD along with CerTest Biotec 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. The new CerTest kit will offer rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and Respiratory Syncytial Virus A and B.

Industry Prospects

Per a report by MarketsandMarkets, the global molecular diagnostics market size is projected to reach $11.54 billion by 2023 from $7.71 billion in 2018, at a CAGR of 8.4%. Factors like technological advancements in molecular diagnostics and the rising prevalence of infectious diseases are likely to drive the market.

Price Performance

Over the past three months, shares of the company have gained 5.7% compared with the industry’s growth of 11%.

Zacks Rank and Key Picks

Currently, BD carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the broader medical space are Abbott Laboratories ABT, Myomo, Inc. MYO and Apyx Medical Corporation APYX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Abbott Laboratories has a projected long-term earnings growth rate of 14%.

Myomo has a projected long-term earnings growth rate of 22%.

Apyx Medical has an estimated long-term earnings growth rate of 27%.

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