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Hologic’s Panther Fusion Flu AdV/hMPV/RV Assay Wins FDA Nod


Hologic, Inc.HOLX announced the receipt of 510(k) clearance from the FDA for its Panther Fusion AdV/hMPV/RV assay. This is a multiplex assay that runs on the new Panther Fusion system and detects Adenovirus, human Metapneumovirus and Rhinovirus.

Per the company, the initial set of modular assays for respiratory viruses is completed with this FDA nod. The latest Panther Fusion assays offer a new-age approach to syndromic respiratory testing with the prolific ability to run one, two or all three assays from a single patient specimen. This assay complements the other two FDA-approved assays namely, the Panther Fusion Flu A/B/RSV and the Panther Fusion Paraflu variety.

The Panther Fusion module is an in-lab upgrade to the original Panther instrument. Apart from the Panther platform’s existing benefits, this new system adds flexibility of PCR (polymerase chain reaction) to the proven performance of transcription-mediated amplification (TMA), used by the Panther system.

Market Prospects

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

Hologic is consistently trying to expand its Diagnostic segment, which generated a 36.3% of total revenues in the last reported fiscal fourth quarter despite facing a year-over-year decline of 6.5%. Under this segment, Molecular Diagnostics revenues increased 14.3% (13.8% at CER). Notably, by the end of 2017, Hologic had shipped about 1,300 Panthers to Diagnostics customers worldwide.

Stock Performance Solid

Over the past month, Hologic has outperformed the broader industry. The stock has gained 4.8% against the 1% decline of the broader industry.

Recent Regulatory Approvals at a Glance

Recently, the company announced the receipt of FDA 510(k) clearance for its Quantra 2.2 Breast Density Assessment Software.

In October, Hologic announced the receipt of 510(k) clearance from the FDA for the Panther Fusion Paraflu assay. Also, the company announced the FDA approval for Panther Fusion Flu A/B/RSV assay running on the new Panther Fusion system.

The company also received an FDA approval for the commercial launch of the Aptima Herpes Simplex Virus (HSV) 1 & 2 molecular assay on the fully automated Panther system in June. Also, it received the FDA’s expanded clearance for its SculpSure product in June.

We believe this recent spree of regulatory approvals for the company’s array of products to boost the share price further.

Zacks Rank and Key Picks

Hologic carries a Zacks Rank #3 (Hold).

A few better-ranked medical stocks are PetMed Express, Inc. PETS, Align Technology, Inc. ALGN and Myriad Genetics, Inc. MYGN, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

PetMed has a long-term expected earnings growth rate of 10%. The stock has surged roughly 83.9% over a year.

Align Technology has a long-term expected earnings growth rate of 28.9%. The stock has gained 134.7% in a year.

Myriad Genetics has a long-term expected earnings growth rate of 15%. The stock has soared 94.9% in a year.

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