Becton, Dickinson and Company BDX, popularly known as BD, recently announced the receipt of the CE Mark for the BD MAX Respiratory Viral Panel (“RVP”), which is the new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus (“RSV”) from the company. The BD MAX RVP assay is an RT- PCR (polymerase chain reaction) assay that helps in detection and differentiation of the mRNA of SARS-CoV-2, flu A, flu B and RSV in approximately two hours using user-friendly and automated workflow of the BD MAX System.
It is worth mentioning that the BD MAX System is a molecular diagnostic platform and is currently in use at various laboratories worldwide.
The BD MAX RVP is currently available in countries that recognize the CE mark. BD plans to apply for the FDA’s Emergency Use Authorization in the upcoming weeks.
The latest regulatory clearance is expected to significantly strengthen BD’s foothold in the global Integrated Diagnostic Solutions business, which is a part of the broader Life Sciences arm.
Significance of the Approval
The BD MAX RVP uses a single swab sample to detect whether the patient has COVID-19, flu or RSV. This eliminates the need for multiple tests or doctor visits, thereby enabling clinicians to accelerate the implementation of the appropriate treatment plan. The co-testing approach also aids in increasing testing capacity during the busy flu season and speeding up the time to diagnosis.
Per management, a combined testing panel is crucial to enable clinicians to quickly and efficiently diagnose, differentiate and treat patients to help manage the spread of the infections. This is all the more important as the patient symptoms and clinical presentation can be nearly identical for the triple threats of SARS-Cov-2, influenza and RSV, according to management.
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 regulatory approval is expected to significantly strengthen BD’s business worldwide.
Notable Developments in Life Sciences Arm
Last month, BD announced a partnership with CerTest Biotec. The tie up is aimed at developing a molecular diagnostic test for the monkeypox virus.
The same month, BD announced its plans to unveil a new cell sorting technology — BD FACSDiscover S8 Cell Sorter — at the recently concluded International Society for Advancement of Cytometry CYTO 2022 conference.
In May, BD announced the U.S. launch of its new, fully automated, high-throughput infectious disease molecular diagnostics platform, BD COR MX instrument. The instrument, which has received the FDA’s 510(k) clearance, is a new analytic instrument option for the BD COR System.
The BD stock has lost 0.8% over the past year compared with the industry’s 11.8% fall and the S&P 500's 13.6% decline.
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Zacks Rank & Key Picks
Currently, BD carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are AMN Healthcare Services, Inc. AMN, Omnicell, Inc. OMCL and Masimo Corporation MASI.
AMN Healthcare, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 1.1%. AMN’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 15.6%.
You can see the complete list of today’s Zacks #1 Rank stocks here.
AMN Healthcare has gained 13.1% against the industry’s 45.3% fall in the past year.
Omnicell, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 20%. OMCL’s earnings surpassed estimates in three of the trailing four quarters and missed the same in the other, the average beat being 13.4%.
Omnicell has lost 24.1% compared with the industry’s 55.2% fall over the past year.
Masimo, carrying a Zacks Rank #2 at present, has an earnings yield of 3.5% against the industry’s negative yield. MASI’s earnings surpassed estimates in the trailing four quarters, the average beat being 4.4%.
Masimo has lost 48.2% compared with the industry’s 26.3% fall over the past year.
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