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In Brief This Week: Lucira Health, Cepheid, Quest Diagnostics, and More

NEW YORK – Lucira Health this week said its customers should dispose of Copan swabs distributed from April 22 through Sept. 22 that were included in the Lucira COVID-19 All-In-One Test Kit and Lucira Check It COVID-19 Test Kit. In July, Copan had asked the US Food and Drug Administration for a recall of its FloqSwabs, saying a specific "sterility assurance level … cannot be guaranteed due to intentional fraud and data integrity issues at the contract sterilizer, Steril Milano." Lucira said that its estimated expenses related to the recall were between $75,000 and $85,000, and that it intends to pass through all related expenses to Copan. The swabs recall had no impact on its revenue recorded during the distribution period, Lucira said. The Emeryville, California-based developer of molecular diagnostic tests for infectious diseases added that it is offering a replacement swab for customers who purchased its test kits with the recalled swabs.

Florida Cancer Specialists & Research Institute this week said it has expanded its molecular testing capabilities within its pathology laboratory in Fort Myers and now will offer a broad suite of next-generation sequencing tests to patients with solid tumors and hematologic malignancies seen at its clinics throughout the state. FCS has independently validated the Illumina 500-plus solid tumor panel for use in its laboratory, and also has access to Invitae's VariantPlex Myeloid panel and FusionPlex PanHeme panel performed on the Illumina NextSeq 550Dx sequencing platform. The results from these tests will be interpreted by FCS' variant scientists using PierianDx CGW software. According to FCS, these capabilities will improve precision oncology therapy access for patients seen in the community setting and will identify clinical trial opportunities.

Cepheid announced this week that it has launched direct commercial operations in Canada, including direct service, order management, and technical support. The Danaher subsidiary’s GeneXpert instruments are already in use across Canada, and Cepheid said in a statement that the operations launch will help it strengthen its partnerships with Canadian healthcare leaders. The offices will be based in Markham, Ontario.

Quest Diagnostics and the Boston Athletic Association said this week that Quest will exclusively provide on-site COVID-19 testing for the Boston marathon. Quest will test runners, staff, and volunteers in the days before the marathon, which is scheduled to take place on Oct. 11.

Co-Diagnostics said this week that the Saragene Dengue and Chikungunya Multiplex RT-PCR test by its CoSara Diagnostics joint venture in India has received clearance from that country’s Central Drugs Standard Control Organization.

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.