IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is to disrupt the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.
During March and April, The Wall Street Journal published a series of articles that revealed the extent of the problems Theranos had with CLIA inspections of its clinical laboratory in Newark, California. The Journal published its analysis of the CLIA inspection report and the serious deficiencies identified during lab inspections that happened last fall and earlier this year.
On April 13, the Journal published the sanction letter that the federal Centers for Medicare and Medicaid Services had sent to Theranos on March 18. CMS wrote that, “Based on a finding of immediate jeopardy and the laboratory’s failure to meet all CLIA condition level requirements,” it proposed sanctions against Theranos.
The sanctions include revocation of the lab’s CLIA certificate and cancellation of the laboratory’s approval to receive Medicare payments. With revocation of the lab’s CLIA license, the lab’s owners and medical director will be banned from “owning, operating (or directing) a laboratory for at least two years from date of the revocation.”
The next hammer blow to Theranos came just five days later. On April 18, the Journal published a story describing how Theranos was the subject of a criminal investigation by the U.S. Department of Justice, and that the Securities and Exchange Commission was looking into the activities of the lab company. Theranos acknowledged that it was aware of these federal probes.
For its part, Theranos made two significant announcements last month. On April 7, it disclosed that it had named six more members to its two-member Scientific and Medical Advisory Board. Five of the six new members are past presidents of the American Association of Clinical Chemistry (AACC).
Next, on April 18, the AACC issued a press release stating that Theranos Founder and CEO Elizabeth Holmes would present scientific data on its diagnostic technology at a plenary session of the AACC’s annual meeting in Philadelphia. The session will happen at 12-1:30 PM on Monday, August 1. That may turn out to be the best-attended session at this year’s annual meeting!
Additional details of Theranos’ woes are available at DarkDaily.com.