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BD's (BDX) First Self-Collection HPV Screening Assay Gets CE Mark

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Becton, Dickinson and Company (BDX - Free Report) , also popularly known as BD, recently announced the receipt of the CE mark for the industry’s first self-collection claim for human papillomavirus (HPV) screening. Notably, this new claim enables laboratories and facilities to process self-collected samples through a BD diluent tube utilizing the BD Onclarity HPV Assay on either the BD Viper LT or the BD COR System.

It is worth mentioning that the BD Viper LT is in use globally and the BD COR System, which launched last year, is in use across Europe.

Notably, the BD Onclarity HPV Assay detects and identifies 14 high-risk HPV types in a single analysis and offers genotyping information from specimens collected for cervical cancer screening purposes in the BD SurePath Collection Vial, Hologic PreservCyt Solution (not approved in the United States), and Cervical Brush Diluent tube (not approved in the United States).

This announcement is likely to provide a boost to BD Life Sciences segment.

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The main objective of cervical cancer screening is simple but critical – to detect pre-cancer before it develops into cancer. Self-collection allows women to have greater access to testing and also reassures regarding the reliability of HPV testing of self-collected samples being the same as the ones done before a clinician.



Moreover, amid this pandemic, at-home collection will aid in addressing this challenge of reaching women who fail to attend routine cervical cancer screening.

HPV self-sampling combined with extended genotyping aids in giving more attention to those women who are highest risk, while not overtreating those at very low risk.

Market Prospects

Per a report by ReportLinker, the global HPV testing market is anticipated to witness a CAGR of over 12% during 2019-2025. Rising prevalence of HPV infections, emergence of point-of-care diagnostics/rapid HPV tests and growing demand for HPV Co-testing are likely to drive this market’s growth. Hence, the announcement is well-timed.

Recent Developments

In April, BD received 510(k) clearance from the FDA for the Pristine Long-Term Hemodialysis Catheter, which is a new hemodialysis catheter with a unique side-hole free symmetric Y-Tip distal lumen design. Notably, the Pristine Catheter is going to be available in the United States in May 2021.

In March, the company received emergency use authorization (EUA) from the FDA for a new, rapid antigen test, which can simultaneously identify SARS-CoV-2, influenza A and influenza B in a single test. Interestingly, the new test takes around 15 minutes to run on the BD Veritor Plus System and helps to distinguish between SARS-CoV-2, influenza A and influenza B by offering definitive positive or negative individual display readouts for all three.

Price Performance

Shares of the company have lost 8.4% in the past year against the industry’s growth of 28.8%.

Zacks Rank & Key Picks

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

Some better-ranked stocks from the broader medical space are HCA Healthcare, Inc. (HCA - Free Report) , DaVita Inc. (DVA - Free Report) and Amedisys, Inc. (AMED - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

HCA Healthcare’s long-term earnings growth rate is expected at 12.3%.

DaVita’s long-term earnings growth rate is estimated at 14.4%.

Amedisys’ long-term earnings growth rate is estimated at 12%.

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