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tripleevenfall quotes a report from The Wall Street Journal: Theranos Inc. said it will shut down its blood-testing facilities and shrink its workforce by more than 40% (Warning: may be paywalled; alternate source). The company said it had 790 full-time employees as of August 1. The moves mark a dramatic retreat by the Palo Alto, Calif., company and founder Elizabeth Holmes from their core strategy of offering a long menu of low-price blood tests directly to consumers. Those ambitions already were endangered by crippling regulatory sanctions that followed revelations by The Wall Street Journal of shortcomings in Theranos's technology and operations. Theranos later voided all results from its proprietary device for 2014 and 2015, though the company said it wasn't aware of any patient harm resulting form its tests. Ms. Holmes said in a statement: "We will return our undivided attention to our miniLab platform. Our ultimate goal is to commercialize miniaturized, automated laboratories capable of small-volume sample testing, with an emphasis on vulnerable patient populations, including oncology, pediatrics, and intensive care."

An anonymous reader quotes a report from TechCrunch: This past week, the U.S. Food and Drug Administration mandated testing for the Zika virus at all U.S. blood centers. That juices demand for Zika-testing technology, but one company that isn't welcome to provide it yet is Theranos. The beleaguered blood analysis startup has run afoul of the FDA, yet again, The Wall Street Journal reports (Warning: may be paywalled). Specifically, regulators found that in developing and testing a new Zika-diagnostic technology, Theranos failed to use proper patient safety protocols, the type approved by an institutional review board. Such protocols are critical in ensuring the ethical treatment of patients involved in studies, and their safety. Theranos had sought the same FDA authorization, but voluntarily withdrew its request once regulators called the startup out, this time, on the safety protocols issue.

An anonymous reader quotes a report from Engadget: The Wall Street Journal reports U.S. regulators have devised to ban the owners and operators of Theranos from running a lab for two years. That includes CEO and founder Elizabeth Holmes, as confirmed by a press release issued tonight. The Centers for Medicare and Medicaid Services (CMS) revoked the lab's Clinical Laboratory Improvement Amendments (CLIA) certificate and imposed a civil money penalty for an unspecified amount. The ban does not take effect for 60 days, however Theranos says it will not do any testing at the Newark, CA lab CMS investigated, and instead will serve customers from its lab in Arizona. Elizabeth Holmes wrote: "We accept full responsibility for the issues at our laboratory in Newark, California, and have already worked to undertake comprehensive remedial actions. Those actions include shutting down and subsequently rebuilding the Newark lab from the ground up, rebuilding quality systems, adding highly experienced leadership, personnel and experts, and implementing enhanced quality and training procedures. While we are disappointed by CMS' decision, we take these matters very seriously and are committed to fully resolving all outstanding issues with CMS and to demonstrating our dedication to the highest standards of quality and compliance."

dmr001 writes: As seen previously, Palo Alto startup Theranos planned to put the power of affordable lab work directly in the hands of patients with tiny fingerprick samples taken at Walgreen's, with four hour turnaround. The company claimed their tests were "made possible by advances in the field of microfluidics." But they were cagey about methodology and didn't use FDA approved analyzers.

Now, the Wall Street Journal reports (paywalled) (among others) that all but one of Theranos' analyzers currently in use is off the shelf, and that their tiny samples may not always have been accurate. Typically cagey founder Elizabeth Holmes vigorously disputes the criticism of her $9 billion startup, but entrenched players like Quest Diagnostics and LabCorp (which do quite well charging orders of magnitude above Theranos' prices) are likely doing a happy dance.

Physicians worrying about patients bringing in their own carcinoembryonic antigen levels and Epstein Barr Virus panels to confirm their Internet diagnoses of cancer and chronic fatigue may also be breathing sighs of relief, albeit with bittersweet regret at the potential loss of the price advantage and milliliter samples.