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BD's (BDX) New FDA Approval to Improve Cervical Cancer Testing
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Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, recently received the FDA’s approval for the BD Onclarity HPV (human papillomavirus) Assay to be used with the ThinPrep Pap Test. The two most common Pap vials currently used by laboratories in the United States are the BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial.
The ThinPrep Pap Test with the BD Onclarity HPV Assay can be used on the BD COR or BD Viper LT instrument platforms without the need to change current cytology equipment.
The BD Onclarity HPV Assay has received the FDA’s approval for use in vaccinated women. As the previously vaccinated sub-population ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18. This is expected to increase the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.
The BD Onclarity HPV Assay detects and identifies 14 high-risk HPV types in a single analysis.
The latest regulatory approval is expected to solidify BD’s foothold in the global Molecular Diagnostics business, thereby boosting its overall Life Sciences segment.
Significance of the Approval
The inclusion of the ThinPrep Pap Test is expected to improve access to the benefits of the BD HPV assay, which is the only FDA-approved assay that tests for an extended set of HPV types individually and particularly for HPV31 (a specific type of HPV that poses a high risk for causing cervical cancer). Individual identification of HPV31 will likely help better determine risk for cervical pre-cancer, which may lead healthcare providers to different clinical decision-making, unlike when assessing risk when multiple genotypes are reported collectively.
Per management, as most tests report multiple HPV types in a single pooled result, it may mask the true risk of developing cervical cancer. Hence, management believes that being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer. Per estimates, HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity HPV Assay is the only FDA-approved assay that screens for it individually.
Industry Prospects
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 clearance is expected to significantly strengthen BD’s business worldwide.
Recent Developments in the Life Sciences Arm
This month, BD received the FDA’s Emergency Use Authorization for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus — BD Respiratory Viral Panel assay for BD MAX System. The test, for use on the BD MAX Molecular Diagnostic System, is expected to aid in combatting illness in the current and future respiratory virus seasons.
Also, this month, BD announced a new instrument for single-cell multiomics analysis that will enable scientists to run high-throughput studies without compromising sample integrity. This is expected to potentially accelerate time to discovery across a wide range of disciplines, including immunology, genetic disease research and cancer and chronic disease research.
Again, in February, BD reported its first-quarter fiscal 2023 results, wherein it registered an improvement in the overall base revenues. BD Life Sciences segment saw the Integrated Diagnostic Solutions unit’s strong growth in the base business (driven by strong demand for BD’s respiratory testing portfolio, which was partly aided by the timing of dealer orders, strong BD Kiestra lab automation installations and leveraging its higher BD MAX installed base for molecular In Vitro Diagnostic assay growth) and strength in the Biosciences unit.
Price Performance
Shares of BD have lost 12.3% in the past year compared with the industry’s 8.3% decline and the S&P 500's 10.9% fall.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, BD carries a Zacks Rank #2 (Buy).
A few other top-ranked stocks in the broader medical space are Hologic, Inc. (HOLX - Free Report) , McKesson Corporation (MCK - Free Report) and Avanos Medical, Inc. (AVNS - Free Report) .
Hologic, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%.
Hologic has gained 12.6% against the industry’s 15.2% decline in the past year.
McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.4%. MCK’s earnings surpassed estimates in two of the trailing four quarters and missed the same in the other two, the average beat being 3.4%.
McKesson has gained 30.6% against the industry’s 8.3% decline over the past year.
Avanos, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1.8% for 2023. AVNS’ earnings surpassed estimates in all the trailing four quarters, the average beat being 11%.
Avanos has lost 19% compared with the industry’s 15.2% decline over the past year.
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BD's (BDX) New FDA Approval to Improve Cervical Cancer Testing
Becton, Dickinson and Company (BDX - Free Report) , popularly known as BD, recently received the FDA’s approval for the BD Onclarity HPV (human papillomavirus) Assay to be used with the ThinPrep Pap Test. The two most common Pap vials currently used by laboratories in the United States are the BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial.
The ThinPrep Pap Test with the BD Onclarity HPV Assay can be used on the BD COR or BD Viper LT instrument platforms without the need to change current cytology equipment.
The BD Onclarity HPV Assay has received the FDA’s approval for use in vaccinated women. As the previously vaccinated sub-population ages, the screening population will progressively include women with reduced prevalence of HPV 16 and 18. This is expected to increase the value of extended genotype reporting in a mixed population of vaccinated and unvaccinated women.
The BD Onclarity HPV Assay detects and identifies 14 high-risk HPV types in a single analysis.
The latest regulatory approval is expected to solidify BD’s foothold in the global Molecular Diagnostics business, thereby boosting its overall Life Sciences segment.
Significance of the Approval
The inclusion of the ThinPrep Pap Test is expected to improve access to the benefits of the BD HPV assay, which is the only FDA-approved assay that tests for an extended set of HPV types individually and particularly for HPV31 (a specific type of HPV that poses a high risk for causing cervical cancer). Individual identification of HPV31 will likely help better determine risk for cervical pre-cancer, which may lead healthcare providers to different clinical decision-making, unlike when assessing risk when multiple genotypes are reported collectively.
Per management, as most tests report multiple HPV types in a single pooled result, it may mask the true risk of developing cervical cancer. Hence, management believes that being able to identify high-risk HPV31 individually is critical to the detection and prevention of cervical cancer. Per estimates, HPV31 poses the second-highest risk for cervical pre-cancer, and the BD Onclarity HPV Assay is the only FDA-approved assay that screens for it individually.
Industry Prospects
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 clearance is expected to significantly strengthen BD’s business worldwide.
Recent Developments in the Life Sciences Arm
This month, BD received the FDA’s Emergency Use Authorization for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus — BD Respiratory Viral Panel assay for BD MAX System. The test, for use on the BD MAX Molecular Diagnostic System, is expected to aid in combatting illness in the current and future respiratory virus seasons.
Also, this month, BD announced a new instrument for single-cell multiomics analysis that will enable scientists to run high-throughput studies without compromising sample integrity. This is expected to potentially accelerate time to discovery across a wide range of disciplines, including immunology, genetic disease research and cancer and chronic disease research.
Again, in February, BD reported its first-quarter fiscal 2023 results, wherein it registered an improvement in the overall base revenues. BD Life Sciences segment saw the Integrated Diagnostic Solutions unit’s strong growth in the base business (driven by strong demand for BD’s respiratory testing portfolio, which was partly aided by the timing of dealer orders, strong BD Kiestra lab automation installations and leveraging its higher BD MAX installed base for molecular In Vitro Diagnostic assay growth) and strength in the Biosciences unit.
Price Performance
Shares of BD have lost 12.3% in the past year compared with the industry’s 8.3% decline and the S&P 500's 10.9% fall.
Image Source: Zacks Investment Research
Zacks Rank & Other Key Picks
Currently, BD carries a Zacks Rank #2 (Buy).
A few other top-ranked stocks in the broader medical space are Hologic, Inc. (HOLX - Free Report) , McKesson Corporation (MCK - Free Report) and Avanos Medical, Inc. (AVNS - Free Report) .
Hologic, sporting a Zacks Rank #1 (Strong Buy) at present, has an estimated long-term growth rate of 15.2%. HOLX’s earnings surpassed the Zacks Consensus Estimate in all the trailing four quarters, the average beat being 30.6%.
You can see the complete list of today’s Zacks #1 Rank stocks here.
Hologic has gained 12.6% against the industry’s 15.2% decline in the past year.
McKesson, carrying a Zacks Rank #2 (Buy) at present, has an estimated long-term growth rate of 10.4%. MCK’s earnings surpassed estimates in two of the trailing four quarters and missed the same in the other two, the average beat being 3.4%.
McKesson has gained 30.6% against the industry’s 8.3% decline over the past year.
Avanos, carrying a Zacks Rank #2 at present, has an estimated growth rate of 1.8% for 2023. AVNS’ earnings surpassed estimates in all the trailing four quarters, the average beat being 11%.
Avanos has lost 19% compared with the industry’s 15.2% decline over the past year.