NEW YORK – 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.
Qiagen said this week that Genomics England has selected its Clinical Knowledge Base for the Generation Study, a project that aims to sequence the genomes of 100,000 newborns in England to screen for more than 200 rare, treatable diseases. Qiagen's Clinical Knowledge Base, which contains evidence for genetic variants from more than 40 databases that has been curated for clinical relevance, will be used by the study to help interpret variants and report results.
OraSure Technologies said 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.
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.
Aenitis Technologies of France said this week that it has entered into a memorandum of understanding with Bracco Imaging for a strategic partnership to develop acoustic microspheres for sorting and separating rare and complex cells in flow-based applications. The approach, an alternative to magnetic bead-based separation, will rely on Aenitis' acoustophoresis technology and Bracco's expertise in functionalized microsystems. According to Aenitis, it preserves the integrity of sensitive cell populations, enables large-scale manufacturing through continuous flow sorting, targets only desired cells, and meets high regulatory standards for clinical use.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on GenomeWeb.