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Hologic’s Panther Fusion Flu A/B/RSV Assay Gets FDA Approval

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Hologic, Inc. HOLX announced the receipt of 510(k) clearance from the FDA for Panther Fusion Flu A/B/RSV assay running on the new Panther Fusion system. Following its CE mark approval earlier this year, the latest FDA clearance can be treated as a major breakthrough for the company’s molecular diagnostics arm.

The Panther Fusion module is an in-lab upgrade to the original Panther instrument. This adds the flexibility of PCR (polymerase chain reaction) to the proven performance of transcription-mediated amplification (TMA), which is used by the Panther system. The Panther Fusion system has all the benefits of the Panther platform, including full sample-to-result automation, the ability to run multiple tests from a single sample, random access sample processing, continuous loading and STAT capabilities. Moreover, feature to provide higher throughput of up to 335 Panther Fusion tests in eight hours, or up to 500 Fusion and Aptima tests are also incorporated.

In the United States, the Panther Fusion is available as a full system, the testing capabilities of which can be extended by attaching the Panther Fusion module to existing Panther systems.


Apart from the Panther Fusion Flu A/B/RSV assay, two additional respiratory panels, the Panther Fusion Paraflu assay and the Panther Fusion AdV/hMPV/RV (adenovirus/human metapneumovirus/rhinovirus) assay are presently under FDA review. According to the company, these three Panther Fusion respiratory assays will offer a modular approach to testing via the ability to run one, two or all three assays from a single patient specimen. The Panther Fusion assays also use ready-to-use reagents offering up to 60-day on-board stability.

The Panther Fusion system cuts down hands-on time for laboratories as it provides random and continuous access with rapid turnaround time. The Panther Fusion system is the only instrument that combines TMA (transcription-mediated amplification), real-time TMA and real-time PCR with full sample-to-result automation.

Hologic is consistently trying to expand its Diagnostic segment. Notably, the segment generated 35.2% of the total revenue in the last reported third quarter despite facing year-over-year decline of 8.3%.

According to CISION, the molecular diagnostics market is projected to reach a worth of $10.12 billion, at a CAGR of 9.1% from 2016 to 2021. Considering the huge potential of the market, we believe the company’s latest development is quite strategic.

Over the past month, Hologichas underperformed the broader industry. The stock has lost 2.9%, as against the 1.7% gain of the broader industry.

Zacks Rank & Key Picks

Hologic currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the medical sector are Orthofix International N.V. OFIX, Luminex Corporation LMNX and IDEXX Laboratories, Inc. IDXX. Orthofix International and Luminex sport a Zacks Rank #1 (Strong Buy), while IDEXX Laboratories carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Orthofix International has a long-term expected earnings growth rate of 11.8%. The stock has rallied roughly 9.2% over the last three months.

Luminex has a long-term estimated earnings growth rate of 16.3%. The stock gained 7.4% last month.

IDEXX Laboratories has a long-term expected earnings growth rate of 19.8%. The stock has gained 37.1% in the last year.

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