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Hologic Expands Panther Fusion's Menu With Diagnostic Innovation

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Key Takeaways

  • Hologic gains FDA and CE approvals for its new Panther Fusion GI Bacterial and Expanded Assays.
  • Hologic's new assays use rapid molecular tech to detect common bacterial causes of gastroenteritis.
  • Panther Fusion's expanding menu strengthens Hologic's molecular diagnostics growth prospects.

Hologic (HOLX - Free Report) has highlighted the role of its Panther Fusion platform in supporting the future growth of its Diagnostics business. Fusion is an add-on module to the base Panther system, providing a broader and growing in vitro diagnostics menu and Open Access functionality to run laboratory-developed tests. Used mainly for respiratory testing, diversification of the menu has been on the cards to further reinforce the company’s presence in molecular labs. Building on this, Hologic recently announced dual regulatory nods for the Panther Fusion Gastrointestinal (“GI”) Bacterial and Expanded Bacterial Assays — the FDA’s 510(k) clearance and CE marking in the European Union in accordance with In Vitro Diagnostic Regulation (“IVDR”).

Pathogens causing severe diarrheal illness have traditionally required a combination of culture, biochemical and microscopy-based tests, which can be labor-intensive, time-consuming and less sensitive than molecular methods. In these situations, it is crucial for laboratories and clinicians worldwide to have access to tools that can provide rapid and timely informed care.

Hologic’s new GI pathogen detection tests use rapid molecular technology and cover common bacterial causes of infectious gastroenteritis, including Salmonella, Campylobacter and Shigella, and can be run together or in any combination. The assays’ customizable mini-panel format supports specific and tailored testing to individual patients’ needs, helping reduce testing, streamline lab processes, and speed up the time to diagnosis and clinical management.

This year, Panther Fusion is seeing strong traction among customers, aiding Molecular Diagnostics’ growth. With labs able to consolidate a growing menu of assays for women’s health, sexually transmitted infections, respiratory infections, viral load, transplant viruses, and now infectious gastroenteritis, it further reinforces the long-term prospects of this molecular diagnostics platform.

Updates From Hologic’s Diagnostics Peers

QIAGEN’s (QGEN - Free Report) full portfolio of QIAstat-Dx panels is now CE-IVDR certified for use in clinical syndromic testing. This includes an expanded Meningitis/Encephalitis Panel that marks a major advancement in the diagnosis of central nervous system infections. In addition, QIAGEN secured FDA clearance for the QIAstat-Dx Rise — a version of the QIAstat-Dx automated syndromic testing system that offers enhanced throughput with the easiest workflow available to global customers.

Myriad Genetics (MYGN - Free Report) has teamed up with AI technology company SOPHiA GENETICS to develop a global liquid biopsy companion diagnostic test. The partnership will combine MYGN’s advanced laboratory capabilities in the United States to support global testing for clinical trials and SOPHiA GENETICS’ broad, decentralized network of more than 800 connected institutions in more than 70 countries for global test deployment.  Further, a study demonstrated that Myriad Genetics’ molecular residual disease (MRD) test, Precise MRD, successfully delayed the initiation of systemic therapy in patients with oligometastatic clear-cell renal cell carcinoma.

HOLX Stock Performance, Valuation and Estimates

In the past six months, Hologic shares rose 14.2%, well above the industry’s 3.9% growth.  

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Hologic is trading at a forward five-year price-to-earnings of 15.07X, lower than the industry average of 28.28X. The stock carries a Value Score of B at present.

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See how analysts are projecting Hologic’s fiscal 2025 earnings.

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HOLX stock currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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