NEW YORK — Hologic said this week that it has completed its previously announced acquisition of the women's health-focused medical device firm Gynesonics in a deal worth about $350 million. Marlborough, Massachusetts-based Hologic said that the deal will expand access to Gynesonics' US Food and Drug Administration-cleared and CE-marked Sonata System as well as expand Hologic's menu of minimally invasive solutions for heavy periods and fibroids. The system is used for diagnostic intrauterine imaging and transcervical treatment of certain symptomatic uterine fibroids, including fibroids that are associated with heavy menstrual bleeding.
Adaptive Biotechnologies said this week that the new Medicare Clinical Laboratory Fee Schedule (CLFS) rate for its next-generation sequencing-based ClonoSeq test for minimal residual diseases (MRD) is now in effect. The CLFS rate for ClonoSeq was set at $2,007, consistent with the final gap-fill rate recommendation for the test, the company said.
Managed by the Centers for Medicare and Medicaid Services (CMS), ClonoSeq's CLFS rate, which was finalized after a year of evaluation, may become a benchmark for other payors in the US for establishing their rate schedules for ClonoSeq, according to Adaptive.
Laboratory Corporation of America this week said its board has declared a cash dividend of $.72 per share, payable on March 12 to shareholders of record at the close of business on Feb. 27.
Indica Labs this week announced that Danaher subsidiary Leica Biosystems has agreed to make a significant strategic investment in the company. Under the agreement, the two firms plan to launch a diagnostic digital pathology platform that pairs Leica's Aperio scanner portfolio with a customized version of Indica Labs' HALO AP image management software for use by clinical customers. The platform will be exclusively available from Leica Biosystems and will provide a full suite of digital pathology workflow functionalities and will support onsite and remote primary diagnosis, the firms noted.
Leica also expects to integrate Indica Labs into Leica's companion diagnostics development program to develop artificial intelligence-based companion diagnostic tests.
OraSure announced this week that it has obtained an expanded indication for its OraQuick HIV Self-Test. The US Food and Drug Administration approved the firm's supplement to its premarket approval application for a labeling change reducing the approved age to individuals 14 years and older. Previously the test was approved for use in those 17 years of age and older. OraSure said the change now enables adolescents to access HIV testing.
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.