Lab News
Study revises thinking on genes and breast cancer risk
January 22, 2021 -- Women who have mutations associated with breast cancer are not necessarily at higher risk as previously thought, according to a large review of epidemiology studies published January 20 in the New England Journal of Medicine.
CMS rejects Epi proColon payments, sets standards for cancer blood tests
January 21, 2021 -- The U.S. Centers for Medicare and Medicaid Services (CMS) on January 19 issued a national coverage determination rejecting coverage of the Epi proColon blood test for colon cancer screening. In the process, the agency also set standards for colon cancer blood tests going forward.  Discuss
Qiagen plans FDA resubmission of coronavirus rapid antigen test
January 21, 2021 -- Qiagen is planning a first-quarter resubmission of its QIAreach rapid antigen test to the U.S. Food and Drug Administration (FDA). In separate news, the company said that its molecular diagnostics are effective for detection of the various known strains of the coronavirus.
Illumina claims another win in BGI patent dispute, this time in U.K.
January 21, 2021 -- Illumina claimed another success in its patent infringement litigation against BGI over its sequencing-by-synthesis technology, with a favorable judgment in the U.K.
FDA commissioner Hahn leaves agency
January 20, 2021 -- Dr. Stephen Hahn, the commissioner of the U.S. Food and Drug Administration (FDA), has left the agency. He is being replaced on an interim basis by longtime FDA regulator Dr. Janet Woodcock.  Discuss
HHS outsources review of some lab-developed COVID-19 tests
January 20, 2021 -- The U.S. Department of Health and Human Services (HHS) has decided to outsource some review of lab-developed tests (LDTs) for COVID-19 to private companies. HHS has issued one of the first contracts for external review of LDTs to NDA Partners of Rochelle, VA.
Hamilton, Rhinostics to improve COVID-19 test processing
January 20, 2021 -- Hamilton Storage and Rhinostics have partnered to improve the processing of COVID-19 test samples.
Thermo Fisher to acquire Mesa Biotech for $450M
January 20, 2021 -- Thermo Fisher Scientific plans to acquire point-of-care molecular diagnostics provider Mesa Biotech for $450 million in cash.
Hexapod personal protective booths cut testing costs for COVID-19
January 19, 2021 -- As the COVID-19 pandemic continues to evolve, hospitals and labs have had to get creative, overcome hurdles, and adapt their practices to perform safer COVID-19 testing. One solution is the Hexapod, which is a personal protective booth that allows healthcare providers to undertake swab testing without physically contacting patients.  Discuss
Ortho files for IPO to sell 70M shares
January 19, 2021 -- Ortho Clinical Diagnostics has filed for an initial public offering (IPO) that aims to sell 70 million shares at a price between $20 and $23 per share. The company's shares will be traded on the Nasdaq stock exchange under the symbol "OCDX."
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