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Hologic (HOLX) Gets FDA Nod for Multiplexed Respiratory Test

Hologic, Inc. HOLX recently announced the receipt of the FDA 501(k) approval for its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The multiplexed respiratory test is available in the United States with new RespDirect collection kit.

Hologic has sent more than 200 million SARS-CoV-2 laboratory diagnostic tests around the world since the COVID epidemic started. Following the July 2022 news of the CE certification for the same test in Europe, the FDA's approval of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay strengthens Hologic's position as one of the biggest molecular diagnostic firms in the world.

The latest development will likely bolster Hologic’s Molecular Diagnostics business.

More on Panther Fusion Assay

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay is done using the fully-automated, high-throughput Panther Fusion system, which can process more than 1,000 tests in a 24-hour period and gives preliminary results in about three hours.

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This system's adaptability, combined with Hologic's respiratory virus menu, provides a variety of testing possibilities from a single sample and enables laboratories and healthcare practitioners to tailor patient testing depending on medical history and regional prevalence.

Zacks Investment Research
Zacks Investment Research

Image Source: Zacks Investment Research

This assay is a molecular diagnostic test that distinguishes between the four most common respiratory viruses, including the respiratory syncytial virus (RSV), influenza A, influenza B and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Benefits of the Panther Fusion Assay

The Panther Fusion SARS-CoV-2/Flu A/B/RSV assay debuts with the new RespDirectTM collection kit, which enables laboratories to directly load samples for processing on the Panther Fusion system without any uncapping or specimen transfer steps, saving time and lowering the risk of error, repetitive stress injuries and virus exposure.

A number of respiratory infections, including COVID, the flu and RSV, circulated concurrently throughout communities this past winter and frequently displayed identical symptoms, making diagnostics challenging. Per Hologic’s management, the Panther Fusion assay will be a vital tool in assisting doctors in figuring out, which respiratory virus or coinfection patients are carrying that will help them decide on the best course of therapy.

Industry Prospects

Per Grand View Research, the global respiratory disease testing/diagnostics market size was valued at $5.0 billion in 2016 and is expected to witness a CAGR of 3.3% by 2025. The rising rate of pollutants in the air and the release of hazardous gases causing lung diseases including COPD and other respiratory diseases around the world is driving the market.

Progress Within Molecular Diagnostics Business

In Diagnostics, Molecular Diagnostics continues to register strong growth during fiscal second quarter. The growth was driven by BVCVTV vaginitis panel and aided by the core STI menu, including Clemidiagonrhia, HPV and Trich. The company witnessed strong contributions from Biotheranostics and respiratory menu on the Panther Fusion during the quarter.

The company’s expanded global installed base of Panthers, over 3,250 strong represents the catalyst for the division's sustained growth. The superior workflow of the Panther combined with a broad menu of nearly 20 FDA-approved assays across the Panther and Panther Fusion systems, creates tremendous value for customers and differentiates us from competitors.

Price Performance

In the past year, Hologic’s shares inched up 3.4% compared with the industry’s fall of 2.4%.

Zacks Rank & Other Key Picks

Hologic currently carries a Zacks Rank #2 (Buy).

A few other top-ranked stocks in the broader medical space are Addus Homecare Corporation ADUS, Merit Medical Systems, Inc. MMSI and Davita Inc DVA.

The Zacks Consensus Estimate for Addus Homecare’s 2023 earnings indicates a 10.9% year-over-year growth. The Zacks Consensus Estimate for ADUS’s 2023 earnings has moved 0.5% north in the past 30 days.

Addus Homecare has a long-term estimated growth rate of 11.8%. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Merit Medical reported a first-quarter 2023 adjusted EPS of 64 cents, beating the Zacks Consensus Estimate by 16.4%. Revenues of $297.6 million surpassed the Zacks Consensus Estimate by 5.9%. It currently carries a Zacks Rank #2.

Merit Medical has a long-term estimated growth rate of 11%. MMSI’s earnings surpassed estimates in all the trailing four quarters, the average surprise being 20.2%.

DaVita, carrying a Zacks Rank #2 at present, has a long-term estimated growth rate of 14.6%. DVA’s earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise being 17.3%.

DaVita has lost 1.9% compared with the industry’s 18% decline in the past year.

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DaVita Inc. (DVA) : Free Stock Analysis Report

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