Hologic Acquires Molecular Diagnostic Test Developer for $795M

Hologic, a global leader in women’s health, recently signed a $795 million definitive agreement to acquire Mobidiag Oy, a commercial stage developer of innovative molecular diagnostic tests.

Mobidiag develops and markets polymerase chain reaction (PCR)-based tests for acute care conditions, including gastrointestinal and respiratory infections, antimicrobial resistance management, and healthcare-associated infection.

The company’s Amplidiag and Novodiag platforms are automated instruments that deliver rapid turnaround times ranging from 50 minutes to two hours.

“Acquiring Mobidiag will further strengthen our international and diagnostics businesses by enabling us to expand into the large, fast-growing acute care adjacency with a near-patient testing solution that offers ease of use, multiplex capability and rapid turnaround time,” Jan Verstreken, group president of international at Hologic, said in the announcement. 

“We believe that Mobidiag has developed a differentiated platform that addresses many of the historical challenges of multiplexed point-of-care molecular testing,” Versreken continued.

The Ampldiag product family consists of high-throughput molecular diagnostics with PCR amplification kits that can be used with an automated platform.

The molecular diagnostics tests include Amplidiag, Amplidiag Easy, and Amplidiag Analyzer. All of these tests are designed for mid to high-volume screening purposes.

Mobidiag’s Novodiag is also a fully automated and on-demand molecular diagnostic platform for the detection of infectious diseases and antibiotic resistance.

Both the platforms contain multiplexing, which enables multiple pathogens to be identified in a single sample. This streamlines workflows for laboratories and provides rapid results to physicians, a Hologic spokesperson explained.

One example is gastrointestinal infections, which can be caused by over 25 organisms.

Highly multiplexed assays allow clinicians to identify which organism is responsible for infection quickly, accurately, and efficiently, the company stated.

“One of our key goals is to use our strong cash flow to create a larger, faster growing company for a post-pandemic world,” said Steve MacMillan, chairman, president, and chief executive officer of Hologic.  

“Mobidiag provides an exceptional new growth platform, which will generate long-term value by enabling us to enter the acute care market, which is expected to roughly double in the next five years, with a differentiated, highly competitive solution,” MacMillan continued.

Last year, Mobidiag generated nearly $42 million of revenue. Hologic intends to invest in assay development to drive growth of the Novodiag platform.

Therefore, Hologic’s acquisition of Mobidiag is expected to be about $0.10 dilutive to the company’s non-GAAP earnings per share in fiscal year 2022 and slightly dilutive in 2023, Hologic explained.

The acquisition is expected to close early in the fourth quarter of 2021, subject to certain required regulatory approvals and other customary closing conditions.

Point-of-care for acute care conditions allows healthcare providers to make rapid treatment decisions when diagnosing a patient’s condition or monitoring treatment response.  

Simplifying the testing process ensures that clinicians focus on providing effective quality care to patients in greatest need.

At the end of January, Thermo Fisher Scientific entered into a $450 million definitive agreement to acquire San Diego-based Mesa Biotech and boost the availability of reliable molecular diagnostic tests at the point of care.

Mesa Biotech has developed and commercialized PCR-based, rapid point-of-care testing platforms that detect diseases such as COVID-19, influenza A and B, Strep A, and other respiratory diseases.

The company’s Accula Flu A/Flu B and Strep A tests have gained FDA 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waivers. The test also gained FDA emergency use authorization (EUA) for COVID-19 in-vitro diagnostic testing.

Mark Stevenson, executive vice president and chief operating officer at Thermo Fisher Scientific stated that the addition of Mesa Biotech's PCR-based test will help the company further meet the continuing demand for testing, especially during the COVID-19 pandemic.