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Hologic (HOLX) Gets FDA Clearance for Aptima HSV 1 & 2 Test
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Leading diagnostics player Hologic, Inc. (HOLX - Free Report) recently received FDA approval for the commercial launch of the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay on the fully automated Panther system. The test can now be used to detect and differentiate between HSV-1 and HSV-2 infections. Specimens collected, including the Aptima sample, can be tested with the assay.
According to the U.S. Centers for Disease Control and Prevention, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 are considered to be at increased risk for contracting and transmitting HIV-1 (human immunodeficiency virus). Pregnant women infected with HSV-2 are primarily at a risk of transmitting the virus to their babies during birth, which can cause neurological complications.
Meanwhile, for the majority of the last one month, Hologic has been trading above the Zacks categorized Medical - Instruments industry. The company till now has gained 5.1%, compared with 4.3% of the industry. Recently, the company received FDA’s expanded clearance for its SculpSure product. We believe the recent spree of regulatory approvals for its array of products will boost the share price further.
Notably, Hologic conducts various molecular assays on its Panther system, an integrated platform that fully automates molecular testing. The platform significantly saves time for labs by providing random and continuous access with rapid turnaround time. According to Hologic’s Diagnostic Solutions management, tests on the Panther system are said to have benefitted over 40 million people worldwide annually.
Thus, the HSV test on Panther system is useful for labs as it offers faster testing results and improved detection of sexually transmitted infections like herpes. Many laboratories traditionally conduct HSV testing via live culture, which is time consuming. The method also delivers results in days rather than hours. Subsequently, studies have shown that HSV molecular diagnostic tests are more sensitive than live culture samples.
As per a MarketsandMarkets report, the global molecular diagnostics market is estimated to reach a worth of $10.12 billion, at a CAGR of 9.1%. Thus, Hologic is constantly making efforts to fortify its position in this space with qualitative diagnostic offerings. Management claims that the combination of performance and automation will help labs become more efficient in meeting current demand for monitoring HSV infections.
Zacks Rank and Key Picks
Hologic currently carries a Zacks Rank #3 (Hold). A few better-ranked medical stocks are Align Technology, Inc. (ALGN - Free Report) , Inogen, Inc. (INGN - Free Report) and Accelerate Diagnostics, Inc. (AXDX - Free Report) . Notably, Align Technology and Inogen sport a Zacks Rank #1 (Strong Buy), while Accelerate Diagnostics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Align Technology has an expected long-term adjusted earnings growth of almost 24.1%. The stock has added roughly 32.3% over the last three months.
Inogen has a long-term expected earnings growth rate of 17.5%. The stock has gained around 26.2% over the last three months.
Accelerate Diagnostics has an expected long-term adjusted earnings growth of 30%. The stock has gained roughly 24.5% over the last three months.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trade>>
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Hologic (HOLX) Gets FDA Clearance for Aptima HSV 1 & 2 Test
Leading diagnostics player Hologic, Inc. (HOLX - Free Report) recently received FDA approval for the commercial launch of the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay on the fully automated Panther system. The test can now be used to detect and differentiate between HSV-1 and HSV-2 infections. Specimens collected, including the Aptima sample, can be tested with the assay.
According to the U.S. Centers for Disease Control and Prevention, infections with HSV-2 affect more than 24 million Americans. Patients with HSV-2 are considered to be at increased risk for contracting and transmitting HIV-1 (human immunodeficiency virus). Pregnant women infected with HSV-2 are primarily at a risk of transmitting the virus to their babies during birth, which can cause neurological complications.
Meanwhile, for the majority of the last one month, Hologic has been trading above the Zacks categorized Medical - Instruments industry. The company till now has gained 5.1%, compared with 4.3% of the industry. Recently, the company received FDA’s expanded clearance for its SculpSure product. We believe the recent spree of regulatory approvals for its array of products will boost the share price further.
Notably, Hologic conducts various molecular assays on its Panther system, an integrated platform that fully automates molecular testing. The platform significantly saves time for labs by providing random and continuous access with rapid turnaround time. According to Hologic’s Diagnostic Solutions management, tests on the Panther system are said to have benefitted over 40 million people worldwide annually.
Thus, the HSV test on Panther system is useful for labs as it offers faster testing results and improved detection of sexually transmitted infections like herpes. Many laboratories traditionally conduct HSV testing via live culture, which is time consuming. The method also delivers results in days rather than hours. Subsequently, studies have shown that HSV molecular diagnostic tests are more sensitive than live culture samples.
As per a MarketsandMarkets report, the global molecular diagnostics market is estimated to reach a worth of $10.12 billion, at a CAGR of 9.1%. Thus, Hologic is constantly making efforts to fortify its position in this space with qualitative diagnostic offerings. Management claims that the combination of performance and automation will help labs become more efficient in meeting current demand for monitoring HSV infections.
Zacks Rank and Key Picks
Hologic currently carries a Zacks Rank #3 (Hold). A few better-ranked medical stocks are Align Technology, Inc. (ALGN - Free Report) , Inogen, Inc. (INGN - Free Report) and Accelerate Diagnostics, Inc. (AXDX - Free Report) . Notably, Align Technology and Inogen sport a Zacks Rank #1 (Strong Buy), while Accelerate Diagnostics carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Align Technology has an expected long-term adjusted earnings growth of almost 24.1%. The stock has added roughly 32.3% over the last three months.
Inogen has a long-term expected earnings growth rate of 17.5%. The stock has gained around 26.2% over the last three months.
Accelerate Diagnostics has an expected long-term adjusted earnings growth of 30%. The stock has gained roughly 24.5% over the last three months.
Zacks' Hidden Trades
While we share many recommendations and ideas with the public, certain moves are hidden from everyone but selected members of our portfolio services. Would you like to peek behind the curtain today and view them?
Starting now, for the next month, I invite you to follow all Zacks' private buys and sells in real time from value to momentum...from stocks under $10 to ETF to option movers...from insider trades to companies that are about to report positive earnings surprises (we've called them with 80%+ accuracy). You can even look inside portfolios so exclusive that they are normally closed to new investors. Click here for Zacks' secret trade>>