Theranos had hoped to remake itself after unveiling its new miniLab platform last month at the American Association for Clinical Chemistry meeting.
Following CMS sanctions that prohibit her from owning or operating a lab, CEO Elizabeth Holmes presented the company’s new miniLab technology, which miniaturizes analytical testing equipment across different testing methods, including hematology, immunology, clinical chemistry, immunochemistry, and nucleic acid amplification.
The CEO discussed the company’s Zika nucleic acid-amplification-based assay for which the company hoped to secure FDA emergency use authorization.
The company collected finger-stick samples from subjects, including in the Dominican Republic, and shipped those to Palo Alto to run on the miniLab, Holmes said. Subsequently, the company submitted assay validation data for its Zika assay to the FDA.
But the firm has apparently withdrawn its request for emergency use authorization for its Zika assay following an FDA inspection that found irregularities in protocols for the trials conducted in the Dominican Republic.
A week earlier, the company announced it was planning to appeal the sanctions that the Centers for Medicare and Medicaid Services imposed on the company’s Newark, Calif., lab following a litany of quality control failures for the blood testing company.
CMS also yanked the company’s CLIA certificate, imposed monetary penalties, suspended the lab’s approval to be reimbursed by Medicare and Medicaid and will oversee a directed correction plan for the beleaguered company (IDDM, July 15). — Tamra Sami