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Hologic's (HOLX) Cervical Cancer Screening System Gets CE Mark
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Hologic, Inc. (HOLX - Free Report) announced the receipt of the CE Mark in Europe for its new Genius Digital Diagnostics System, the first digital cytology platform that combines a new A.I. algorithm with advanced digital imaging. This combination is expected to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.
Post receipt of the approval, Hologic becomes the provider of the first CE-Marked comprehensive cervical cancer screening portfolio, which includes services ranging from sample collection to digital diagnosis. Notably, the complete system is scalable and is designed to fit the present and future needs of laboratories.
Other notable offerings from Hologic for cervical cancer screening include the first liquid-based cytology technology, the ThinPrep Pap Test, and the first FDA-approved mRNA-based human papillomavirus (“HPV”) test, the Aptima HPV Assay.
With the recent regulatory receipt, Hologic is expected to strengthen its Diagnostics business on a global scale.
Significance of the Approval
The receipt of the CE Mark enables European laboratories to utilize the Genius Digital Diagnostics to rapidly analyze all cells on a ThinPrep Pap test slide, thus narrowing down the numerous cells to a gallery view of the most diagnostically relevant images. This will provide healthcare providers with the required critical information to guide earlier detection and take better treatment decisions for the patients they serve.
Per management, the latest imaging technology can convert physical glass cytology slides into digital images with superior clarity since A.I. requires superior quality digital images.
Industry Prospects
Per a report by Maximize Market Research Pvt. Ltd., the global cervical cancer screening market was valued $7.98 billion in 2019 and is expected to reach $11.45 billion by 2027 at a CAGR of approximately 6.4%. Factors like growing prevalence of cervical cancer patients and rise in awareness about the same are expected to drive the market.
Given the market potential, the CE Mark approval is a major milestone in strengthening Hologic’s position in the global diagnostics business.
Recent Developments in Diagnostics Arm
Of late, Hologic has witnessed a series of developments in its Diagnostics business.
The company, during its earnings call in November, confirmed that the Diagnostics business had performed robustly, mainly due to the unprecedented surge in COVID-19-related testing.
Hologic, in October, announced the amendment of the FDA’s Emergency Use Authorization (“EUA”) that was initially received for its Aptima SARS-CoV-2 assay in May.
In September, Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for testing of dried blood spot samples. The same month, Hologic received the EUA for its Panther Fusion SARS-CoV-2 assay, which is another molecular diagnostic test for COVID-19.
The FDA authorized Hologic’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay in August.
Price Performance
Shares of the company have gained 52.8% in the past year compared with the industry and S&P 500’s 17.4% and 16.2% growth, respectively.
Zacks Rank & Other Key Picks
Currently, Hologic flaunts a Zacks Rank #1 (Strong Buy).
A few other top-ranked stocks from the broader medical space are ResMed Inc. (RMD - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Align Technology, Inc. (ALGN - Free Report) .
Thermo Fisher’s long-term earnings growth rate is estimated at 18%. It currently carries a Zacks Rank #2.
Align Technology’s long-term earnings growth rate is estimated at 18.3%. It currently carries a Zacks Rank #2.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Image: Bigstock
Hologic's (HOLX) Cervical Cancer Screening System Gets CE Mark
Hologic, Inc. (HOLX - Free Report) announced the receipt of the CE Mark in Europe for its new Genius Digital Diagnostics System, the first digital cytology platform that combines a new A.I. algorithm with advanced digital imaging. This combination is expected to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.
Post receipt of the approval, Hologic becomes the provider of the first CE-Marked comprehensive cervical cancer screening portfolio, which includes services ranging from sample collection to digital diagnosis. Notably, the complete system is scalable and is designed to fit the present and future needs of laboratories.
Other notable offerings from Hologic for cervical cancer screening include the first liquid-based cytology technology, the ThinPrep Pap Test, and the first FDA-approved mRNA-based human papillomavirus (“HPV”) test, the Aptima HPV Assay.
With the recent regulatory receipt, Hologic is expected to strengthen its Diagnostics business on a global scale.
Significance of the Approval
The receipt of the CE Mark enables European laboratories to utilize the Genius Digital Diagnostics to rapidly analyze all cells on a ThinPrep Pap test slide, thus narrowing down the numerous cells to a gallery view of the most diagnostically relevant images. This will provide healthcare providers with the required critical information to guide earlier detection and take better treatment decisions for the patients they serve.
Per management, the latest imaging technology can convert physical glass cytology slides into digital images with superior clarity since A.I. requires superior quality digital images.
Industry Prospects
Per a report by Maximize Market Research Pvt. Ltd., the global cervical cancer screening market was valued $7.98 billion in 2019 and is expected to reach $11.45 billion by 2027 at a CAGR of approximately 6.4%. Factors like growing prevalence of cervical cancer patients and rise in awareness about the same are expected to drive the market.
Given the market potential, the CE Mark approval is a major milestone in strengthening Hologic’s position in the global diagnostics business.
Recent Developments in Diagnostics Arm
Of late, Hologic has witnessed a series of developments in its Diagnostics business.
The company, during its earnings call in November, confirmed that the Diagnostics business had performed robustly, mainly due to the unprecedented surge in COVID-19-related testing.
Hologic, in October, announced the amendment of the FDA’s Emergency Use Authorization (“EUA”) that was initially received for its Aptima SARS-CoV-2 assay in May.
In September, Hologic announced that its CE-marked Aptima HIV-1 Quant Dx assay has been awarded World Health Organization prequalification for testing of dried blood spot samples. The same month, Hologic received the EUA for its Panther Fusion SARS-CoV-2 assay, which is another molecular diagnostic test for COVID-19.
The FDA authorized Hologic’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay in August.
Price Performance
Shares of the company have gained 52.8% in the past year compared with the industry and S&P 500’s 17.4% and 16.2% growth, respectively.
Zacks Rank & Other Key Picks
Currently, Hologic flaunts a Zacks Rank #1 (Strong Buy).
A few other top-ranked stocks from the broader medical space are ResMed Inc. (RMD - Free Report) , Thermo Fisher Scientific Inc. (TMO - Free Report) and Align Technology, Inc. (ALGN - Free Report) .
ResMed’s long-term earnings growth rate is estimated at 14.5%. The company presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Thermo Fisher’s long-term earnings growth rate is estimated at 18%. It currently carries a Zacks Rank #2.
Align Technology’s long-term earnings growth rate is estimated at 18.3%. It currently carries a Zacks Rank #2.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>