Two FDA Inspection Reports Show Theranos’ Blood-Collection ‘Nanotainer’ Was an Uncleared Class II Medical Device

FDA details findings from visits by five federal inspectors at California clinical lab company over 10 days in late August and early September; heavily redacted reports outline 14 compliance deficiencies

Two reports released Tuesday by the Food and Drug Administration (FDA) brought more bad news to Theranos, of Palo Alto, California. The clinical laboratory company has been the subject of much unwanted press coverage since October 15. In the FDA inspection reports, Theranos is required to explain or correct each of 14 “inspectional observations.”

Pathologists, clinical laboratory scientists, and in vitro company executives who take the time to read both FDA reports about the federal agency’s inspection of Theranos will find insights into how FDA assessors view the lab company’s compliance with FDA regulations and requirements. There were 14 issues described in the two FDA reports.

FDA Said Theranos Nanotainer Blood-Collection Container Is Class II Medical Device (more…)

Clinical Pathology Laboratories Still Waiting for Molecular Test Payments, Speakers Report at First Day of Executive War College

For more than a year Medicare contractors have been developing payment rates for the 114 molecular tests and without setting rates, they cannot make payments.

New Orleans, Louisiana, April 30, 2013—Getting paid for molecular test claims submitted under the new molecular CPT codes was a subject of high interest on the opening day of the Executive War College. Most clinical laboratories and pathology groups performing molecular tests nationwide report that they have not been paid for invoices submitted to Medicare contractors since January 1, 2013.

Several sessions were devoted to this important topic. Medicare contractors nationwide have not paid many of the molecular diagnostic test claims submitted since January 1 according to speakers and attendees at the first day of The Dark Report’s 18th Annual Executive War College in New Orleans. (more…)