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Hologic (HOLX) COVID Test With Saliva Sample Gets CE Mark

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Hologic, Inc.’s (HOLX - Free Report) Aptima SARS-CoV-2 molecular diagnostic test recently got CE marking for its use with saliva sample. This assay, which runs on fully automated Panther system, detects the genetic material of the pathogen causing COVID-19.

Most of the COVID-19 diagnostic assays use nasal or throat swabs to detect the virus. However, these are difficult to collect compared to getting saliva specimen. The latest development accordingly should generate significant market demand and further the company’s global footprint in diagnostic testing.

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According to Hologic, saliva collection is noninvasive and painless. The availability of this alternative specimen type should facilitate screening at schools, workplaces and other settings.

To add to this, certain European health authorities have deduced that the established assay performance with saliva combined with its simple procedure of sample collection makes saliva suitable for programs that use repeated screenings.

 

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The Aptima SARS-CoV-2 assay for use with nasopharyngeal and nasal swabs as well as additional specimen types have already received CE Mark.

While vaccination drives are resulting in significant decline in new COVID-19 cases, Hologic management believes that testing will continue to play an important role, particularly in screening programs needed to reopen society.

Looking at the growing demand for tests, Hologic has expanded manufacturing capability to produce Aptima tests significantly. Since spring 2020, the company has shipped more than 100 million Aptima COVID-19 tests globally. Further, around 2,600 Panther systems have been installed in clinical diagnostic laboratories globally.

Hologic's Recent Molecular Diagnostics Drive

Hologic’s management is impressed with continued growth in the core molecular diagnostics business, which accounted for 87.9% of total Diagnostics revenues in the second quarter of fiscal 2021. Global revenues for molecular diagnostics increased 378.4% at constant exchange rate or CER. This was driven by strong global demand for the two SARS-CoV-2 assays (primarily the Aptima SARS-CoV-2 assay and to a lesser extent, the Panther Fusion SARS-CoV-2 assay) that run on the fully-automated Panther and Panther Fusion systems.

The company acquired Mobidiag Oy (a privately-held commercial-stage Finnish-French developer of innovative molecular diagnostic tests and instrumentation) in June. This is expected to strengthen Hologic’s international and diagnostics businesses by enabling it to expand into the large and fast-growing acute care adjacency.

Hologic, in March, acquired a privately-held European developer and manufacturer of molecular diagnostic assays and epigenetics products — Diagenode. This buyout is expected to enable Hologic to offer a broader and more differentiated test menu.

In February, Hologic entered into a multi-year strategic collaboration with Google Cloud that will integrate Google Cloud’s machine learning technologies with Hologic’s Genius Digital Diagnostics System to transform screening and enhance the treatment of cervical cancer worldwide.

Price Performance

Shares of the company have gained 12.1% in a year’s time compared with the industry’s 16.1% rise.

Zacks Rank and Key Picks

Currently, Hologic carries a Zacks Rank #3 (Hold).

A few better-ranked stocks from the broader medical space include Apollo Medical Holdings, Inc. (AMEH - Free Report) , Envista Holdings Corporation (NVST - Free Report) and Teleflex Incorporated (TFX - Free Report) .

Apollo Medical, which carries a Zacks Rank #1 (Strong Buy), has a long-term earnings growth rate of 20%. You can see the complete list of today’s Zacks #1 Rank stocks here.

Envista Holdings, which carries a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 26.4%.

Teleflex, carrying a Zacks Rank #2, has a long-term earnings growth rate of 11%.