Morning Briefing
Summaries of health policy coverage from major news organizations
Theranos In 'Pause Period' As It Looks For FDA Approval
Theranos Inc. founder and Chief Executive Elizabeth Holmes said Wednesday that the Silicon Valley laboratory company is in a 鈥減ause period鈥 as it seeks to get its proprietary technology approved by the U.S. Food and Drug Administration. 鈥淲e have to move, as a company, from the lab framework and quality systems to the FDA framework and quality systems,鈥 Ms. Holmes said, speaking at the WSJD Live global technology conference in Laguna Beach, Calif. (Carreyrou, 10/21)
Assurant Inc. fell the most among large U.S. insurers in New York trading after saying that its health insurance unit posted a third-quarter pretax loss of at least $215 million. Assurant declined 3 percent to $79.72 at 12:41 p.m., the biggest drop in the 21-company Standard and Poor鈥檚 500 Insurance Index. The health loss was driven by higher-than-expected claims on individual medical policies and could be as high as $230 million, the New York-based company said in a filing after markets closed Tuesday. (Chiglinsky and Boyden, 10/21)
Hospital operator Community Health Systems Inc. reported preliminary third-quarter results well below analysts鈥 projections and cut its outlook for the year, citing a decline in admissions and a deterioration in payer mix. Typically, commercial payers, Medicare and Medicaid, which all combined account for a larger share of the company鈥檚 revenue in the latest period, negotiate for lower rate increases. (Armental, 10/21)
It鈥檚 the world鈥檚 largest maker of multiple sclerosis drugs and the most highly valued company in Massachusetts. But size and status couldn鈥檛 shield Biogen Inc. from stumbling in the notoriously risky biotechnology business. On Wednesday, Biogen said that it will cut about 880 jobs, including 400 in its home state, and end several research programs in a restructuring driven by slower sales growth and a multiple sclerosis drug trial that fell short of expectations. (Weisman, 10/21)
And a mammogram machine maker deals with doctors using their machines less while a consumer DNA service relaunches --
Doctors are questioning the gospel of the annual mammogram to detect cancer -- a potential blow to the biggest maker of mammography equipment. Hologic Inc. shares slumped 2.8 percent Tuesday after the American Cancer Society published new guidelines calling for women to wait until age 45 instead of 40 to start annual mammograms, then slow the pace at 55 to screenings every other year. (Cortex, 10/21)
Consumer genetics testing company 23andMe said on Wednesday it was relaunching its personal DNA testing service with a limited menu of tests that have won the approval of the U.S. Food and Drug Administration. The announcement is a major step for the company, which in 2013 was ordered by the FDA to stop selling its Personal Genome Service because the regulatory agency had not approved the tests, which the company was offering directly to consumers. The Personal Genome Service, launched in 2007, analyzed a broad menu of genetic links to disease, including a predisposition to breast and ovarian cancer, certain heart conditions and Alzheimer's. (10/21)
