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Hologic (HOLX) Gets European Nod for Aptima CMV Quant Assay

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Hologic, Inc. (HOLX - Free Report) recently received CE mark for its new Aptima CMV Quant assay in Europe to quantify human cytomegalovirus (CMV). Notably, Aptima CMV Quant assay is the first in a new line of Hologic assays for transplant patients.

For investors’ note, Human CMV is a common DNA virus that belongs to the herpes family and is usually mild or asymptomatic in people with normal immune systems. However, in immunocompromised people like transplant recipients, CMV is a common cause of morbidity and mortality.

Aptima CMV Quant Assay at a Glance

The Aptima CMV Quant assay quantifies the viral load of human cytomegalovirus and is designed to help in the diagnosis and management of solid-organ transplant patients and hematopoietic stem cell transplant patients.

This in-vitro nucleic acid amplification test (NAAT) can be used with human plasma and whole blood samples and employs real-time transcription-mediated amplification (TMA) technology on the fully-automated Panther system.

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Immunocompromised patients are exposed to an array of infections, with CMV being a common complication. Thus, healthcare providers need to quantify and monitor CMV accurately.  It is crucial that CMV levels are quantitated in transplant patients along with monitoring clinical presentation and other laboratory markers as elevated viral loads generally associate to a high risk of CMV disease.

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To guide decisions about starting anti-CMV therapy as well as to monitor response to therapy, recent guidelines suggest at least weekly monitoring of CMV viral load post-transplant. Notably, quantitative nucleic acid amplification testing is the ideal method as it is both quick and sensitive.

Recent Developments

In May 2021, Hologic received FDA premarket approval (PMA) of ThinPrep Genesis processor for cytology processing and specimen transfer for downstream applications. Notably, the ThinPrep Genesis processor is the newest addition to Hologic’s suite of cytology instruments, offering simple, multipurpose and scalable solutions for laboratories of all sizes.

In April 2021, Hologic entered into a definitive agreement to acquire Mobidiag -- an innovator in near-patient, acute care diagnostic testing, for an enterprise value of nearly $795 million. Per management, the acquisition will strengthen Hologic’s international capabilities and diagnostics businesses by expanding into the fast-growing acute care adjacency.

Industry Prospects

Per a report by Grand View Research, the global molecular diagnostics market size was $36.2 billion in 2020 and is expected to reach $49.3 billion by 2028, at a CAGR of 3.9%.

Increasing demand for Point-of-Care testing, demand for self-testing diagnostics and surge in the prevalence of infectious diseases are driving the market.

Price Performance

Shares of the company have gained 18.1% in a year’s time compared with the industry’s growth of 24%.

Zacks Rank and Key Picks

Currently, the company carries a Zacks Rank #5 (Strong Sell).

A few better-ranked stocks from the broader medical space are Envista Holdings Corporation (NVST - Free Report) , Inogen, Inc (INGN - Free Report) and IDEXX Laboratories, Inc. (IDXX - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.

Envista Holdings has an estimated long-term earnings growth rate of 26%.

Inogen has an estimated long-term earnings growth rate of 33%.

IDEXX Laboratories has a projected long-term earnings growth rate of 20%.

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