NEW YORK – Quest Diagnostics said this week that it has completed its previously announced acquisition of select laboratory assets from OhioHealth. Under the agreement, Quest will take over most of the outreach testing previously performed by OhioHealth while OhioHealth will continue to own and operate its network of hospital labs for inpatient and hospital-based outpatient care as well as anatomic pathology and oncology services.
The US Food and Drug Administration this week classified Cue Health's voluntary recall of its Cue COVID-19 test and Cue COVID-19 Test for Home and Over the Counter Use as a Class II recall. Class II recalls are issued when a product may cause a temporary or medically reversible adverse health consequence or where the probability of serious adverse health consequences is remote. Last week, the FDA revoked the Emergency Use Authorizations for both tests. In May, the agency issued a warning letter to the company after an inspection showed Cue made changes to its tests that reduced the reliability of the assays to detect SARS-CoV-2. The firm shut down operations and filed for bankruptcy later that month.
Hologic said this week that it is acquiring women's health-focused medical device firm Gynesonics in a $350 million deal. Gynesonics' flagship Sonata System is a US Food and Drug Administration-cleared and CE-marked instrument for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including fibroids that are associated with heavy menstrual bleeding.
Clinical Microbiomics (CMC) of Denmark said last week that it is acquiring the research services business unit of Microba Life Sciences, a developer of microbiome-derived diagnostics and therapeutics based in Australia. The deal will allow CMC, located in Copenhagen, to expand its microbiome research services worldwide and to boost its representation in Asia-Pacific. Under the agreement, Microba will retain revenue from existing contracts it transfers to CMC and commissions for new contracts with existing customers and new customers it refers to CMC. Furthermore, it will receive milestone-based payments over the next four years. Following the transaction, Microba research services staff in Australia, Singapore, and Korea will join CMC.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.