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Hologic (HOLX) Gets CE Mark for Fusion Molecular Assays
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Hologic, Inc. (HOLX - Free Report) announced the receipt of the CE mark approval for two new molecular assays, Panther Fusion EBV Quant and Panther Fusion BKV Quant. The latest assay approvals expand the company’s transplant pathogen monitoring menu on the Panther Fusion system.
The recent development is likely to expand Hologic’s leading diagnostic molecular scalable solutions offering.
More on the Molecular Assays
The two new molecular assays monitor transplant patients for Epstein-Barr virus (EBV) and BK virus (BKV). Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay quantify the viral load of the respective viruses developed to aid in the diagnosis and management of solid organ transplant patients and hematopoietic stem cell transplant patients.
The assays are in vitro nucleic acid amplification tests (NAAT) that run on the fully automated Panther Fusion system, using real-time Polymerase Chain Reaction technology.
Image Source: Zacks Investment Research
The EBV is validated for use with whole blood and plasma samples, and the BKV assay is validated for use with human plasma and urine samples. Plasma, whole blood and urine specimens are crucial biomarkers when using quantitative NAATs for diagnosis and management of transplant patients to guide treatment decisions and monitor response to therapy.
Benefits of the New Assays
It is worth mentioning that immunocompromised patients are exposed to a range of infections. As both EBV and BKV are extremely common and mainly asymptomatic, it is significant that healthcare providers can quantitate and monitor their presence.
Per Hologic’s management, these assays, along with its Aptima CMV Quant assay launched in Europe in 2021, offer the company’s laboratory partners the tools they need to accurately evaluate transplant patient samples rapidly and confidently.
Industry Prospects
Per a report by Grand View Research, the global molecular diagnostics market size was valued at $36.2 billion in 2020 and is expected to see a CAGR of 3.9%. Rising demand for Point-of-Care testing, demand for self-testing diagnostics and the surge in infectious diseases are the major factors driving the market.
Recent Developments
In May 2022, Hologic announced the receipt of the FDA approval for its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had a solid organ or stem cell transplants. The test is the first to be introduced in the United States by Hologic for post-transplant pathogen detection and monitoring on Hologic’s fully automated Panther system.
In January 2022, Hologic announced the addition of the Aptima SARS-CoV-2 assay to its Global Access Initiative (GAI), a program designed to expand access to critical diagnostic testing in resource-limited countries. Per management, the expansion of the GAI to include Aptima SARS-CoV-2 assay empowers countries to respond to the pandemic and control new waves of COVID-19.
Price Performance
Shares of the company have gained 20.9% in a year against the industry's fall of 17.8%.
Zacks Rank and Key Picks
Hologic currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are UnitedHealth Group Incorporated (UNH - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Alkermes plc (ALKS - Free Report) .
UnitedHealth, with a Zacks Rank #2 (Buy), reported first-quarter 2022 earnings per share (EPS) of $5.49, which beat the Zacks Consensus Estimate by 1.7%. Revenues of $80.1 billion outpaced the consensus mark by 14.2%.
UnitedHealth has an estimated long-term growth rate of 14.8%. UNH’s earnings surpassed estimates in the trailing four quarters, the average surprise being 3.7%.
Medpace reported first-quarter 2022 adjusted EPS of $1.69, which surpassed the Zacks Consensus Estimate by 34.1%. Revenues of $330.9 million outpaced the Zacks Consensus Estimate by 1.1%. It currently has a Zacks Rank #2.
Medpace has a historical growth rate of 27.3%. MEDP’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%.
Alkermes reported first-quarter 2022 adjusted EPS of 12 cents, which surpassed the Zacks Consensus Estimate of a penny. Revenues of $278.6 million outpaced the Zacks Consensus Estimate by 6.2%. It currently sports a Zacks Rank #2.
Alkermes has an estimated long-term growth rate of 25.1%. ALKS’ earnings surpassed estimates in the trailing four quarters, the average surprise being 350.5%.
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Hologic (HOLX) Gets CE Mark for Fusion Molecular Assays
Hologic, Inc. (HOLX - Free Report) announced the receipt of the CE mark approval for two new molecular assays, Panther Fusion EBV Quant and Panther Fusion BKV Quant. The latest assay approvals expand the company’s transplant pathogen monitoring menu on the Panther Fusion system.
The recent development is likely to expand Hologic’s leading diagnostic molecular scalable solutions offering.
More on the Molecular Assays
The two new molecular assays monitor transplant patients for Epstein-Barr virus (EBV) and BK virus (BKV). Panther Fusion EBV Quant Assay and Panther Fusion BKV Quant Assay quantify the viral load of the respective viruses developed to aid in the diagnosis and management of solid organ transplant patients and hematopoietic stem cell transplant patients.
The assays are in vitro nucleic acid amplification tests (NAAT) that run on the fully automated Panther Fusion system, using real-time Polymerase Chain Reaction technology.
The EBV is validated for use with whole blood and plasma samples, and the BKV assay is validated for use with human plasma and urine samples. Plasma, whole blood and urine specimens are crucial biomarkers when using quantitative NAATs for diagnosis and management of transplant patients to guide treatment decisions and monitor response to therapy.
Benefits of the New Assays
It is worth mentioning that immunocompromised patients are exposed to a range of infections. As both EBV and BKV are extremely common and mainly asymptomatic, it is significant that healthcare providers can quantitate and monitor their presence.
Per Hologic’s management, these assays, along with its Aptima CMV Quant assay launched in Europe in 2021, offer the company’s laboratory partners the tools they need to accurately evaluate transplant patient samples rapidly and confidently.
Industry Prospects
Per a report by Grand View Research, the global molecular diagnostics market size was valued at $36.2 billion in 2020 and is expected to see a CAGR of 3.9%. Rising demand for Point-of-Care testing, demand for self-testing diagnostics and the surge in infectious diseases are the major factors driving the market.
Recent Developments
In May 2022, Hologic announced the receipt of the FDA approval for its Aptima CMV Quant assay to quantify the viral load of cytomegalovirus in patients who have had a solid organ or stem cell transplants. The test is the first to be introduced in the United States by Hologic for post-transplant pathogen detection and monitoring on Hologic’s fully automated Panther system.
In January 2022, Hologic announced the addition of the Aptima SARS-CoV-2 assay to its Global Access Initiative (GAI), a program designed to expand access to critical diagnostic testing in resource-limited countries. Per management, the expansion of the GAI to include Aptima SARS-CoV-2 assay empowers countries to respond to the pandemic and control new waves of COVID-19.
Price Performance
Shares of the company have gained 20.9% in a year against the industry's fall of 17.8%.
Zacks Rank and Key Picks
Hologic currently carries a Zacks Rank #3 (Hold).
A few better-ranked stocks in the broader medical space are UnitedHealth Group Incorporated (UNH - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Alkermes plc (ALKS - Free Report) .
UnitedHealth, with a Zacks Rank #2 (Buy), reported first-quarter 2022 earnings per share (EPS) of $5.49, which beat the Zacks Consensus Estimate by 1.7%. Revenues of $80.1 billion outpaced the consensus mark by 14.2%.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
UnitedHealth has an estimated long-term growth rate of 14.8%. UNH’s earnings surpassed estimates in the trailing four quarters, the average surprise being 3.7%.
Medpace reported first-quarter 2022 adjusted EPS of $1.69, which surpassed the Zacks Consensus Estimate by 34.1%. Revenues of $330.9 million outpaced the Zacks Consensus Estimate by 1.1%. It currently has a Zacks Rank #2.
Medpace has a historical growth rate of 27.3%. MEDP’s earnings surpassed estimates in the trailing four quarters, the average surprise being 17.1%.
Alkermes reported first-quarter 2022 adjusted EPS of 12 cents, which surpassed the Zacks Consensus Estimate of a penny. Revenues of $278.6 million outpaced the Zacks Consensus Estimate by 6.2%. It currently sports a Zacks Rank #2.
Alkermes has an estimated long-term growth rate of 25.1%. ALKS’ earnings surpassed estimates in the trailing four quarters, the average surprise being 350.5%.