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Hologic's New Panther Fusion System Gets Health Canada Nod

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Hologic, Inc. (HOLX - Free Report) recently announced the receipt of Health Canada approval for the new Panther Fusion system and Panther Fusion assays for respiratory virus infections.

The Panther Fusion respiratory assays include the Panther Fusion Flu A/B/RSV, Panther Fusion Paraflu and Panther Fusion AdV/hMPV/RV tests. Further, these PCR (polymerase chain reaction)-based assays offer a highly-advanced approach to syndromic testing via the ability to run one, two or all three assays from a single patient’s specimen, based on the patient’s requirements.

According to the company, these new assays, when combined with the Aptima transcription-mediated amplification (TMA) assays, enable the Panther Fusion system — as the only instrument — to combine TMA, real-time TMA and real-time PCR with full sample to result automation.

Notably, 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 to the proven performance of TMA, used by the Panther system.

Further, as a result of this new system, certain additional benefits like increased flexibility, enhanced time and cost efficiency will also be obtained by laboratories.

Per the company, regulatory approval was also obtained for three new assays for flu and respiratory infections. This extended the variety of diagnostic tests, capable of being run on the Hologic system.

Market Prospects

Per CISION, the molecular diagnostics market is projected to reach $10.12 billion at a CAGR of 9.1% from 2016 to 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 35.4% of total revenues in the last reported quarter, despite facing a year-over-year decline of 5.5%. Under this segment, Molecular Diagnostics revenues increased 6.1% (4.4% at constant exchange rate).

Stock Performance Solid

Over the past three months, Hologic has outperformed its industry. The stock has gained 6.4% against the 12.7% decline of the industry.

 

Recent Regulatory Approvals at a Glance

Recently, Hologic announced the receipt of medical device license, issued by Health Canada, to distribute Cynosure’s non-invasive body contouring product, SculpSure, for treating the back, inner and outer thighs, and submental area.

Moreover, the company announced that the FDA has granted premarket approval (PMA) for the ThinPrep Integrated Imager, which will make automated imaging of Pap tests broadly available to laboratories and cytologists in the United States in April.

The company's Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology have also received PMA approval from the U.S. FDA and are now available on the 3Dimensions breast tomosynthesis system.

Again, in January, Hologic announced that FDA has granted PMA approval for the Aptima HBV Quant Assay for quantitation of hepatitis B viral load on the fully-automated Panther system.

Its Cynosure division also announced the launch of TempSure Envi in the same month. This is an FDA-cleared advanced radiofrequency device that minimizes facial fine lines and wrinkles, tightens skin through soft tissue coagulation, and improves the appearance of cellulite.

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

Zacks Rank and Key Picks

Hologic currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the broader medical sector are Illumina, Inc (ILMN - Free Report) , Amedisys, Inc. (AMED - Free Report) and Walgreens Boots Alliance, Inc. (WBA - Free Report) . While Illumina and Amedisys sport a Zacks Rank #1 (Strong Buy), Walgreens Boots carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Illumina expects long-term earnings growth of 19.3%.

Amedisys has an expected long-term earnings growth rate of 18.6%.

Walgreens Boots has an expected long-term earnings growth rate of 10.4%.

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