This is an excerpt from a 400-word article in the May 2 issue of THE DARK REPORT. The complete article is available paid members of the Dark Intelligence Group.
IT’S BEEN AN EVENTFUL COUPLE OF MONTHS for Theranos, the lab testing company that says its goal is disruptive innovation of the clinical laboratory industry. Novelists cannot write fiction as compelling as the unfolding real story about this controversial company.
With The Wall Street Journal continuing to press its investigation of Theranos’ activities, and with various federal agencies scrutinizing and proposing sanctions of the controversial company, there are plenty of new developments for clinical lab stakeholders to follow.
In a letter to Theranos executives, the Center for Medicare and Medicaid Services said it is prepared to:
- revoke the company’s CLIA certificate;
- impose a fine of $10,000 per day;
- suspend and cancel the lab’s approval to receive Medicare payments; and
- impose a two-year ban on the owner, operator, and laboratory director for owning or operating a clinical laboratory.
Pathologists and medical laboratory professionals will recognize that these are among the most severe sanctions that CMS can impose on a laboratory under the Clinical Laboratory Improvement Amendments (CLIA). Further, clinical pathologists who currently serve as medical directors of CLIA laboratories will find it useful to read the entire letter sent to the company on March 18, as it describes how CMS viewed the responses that Theranos provided following a January 25, 2016, letter from CMS describing deficiencies identified during an inspection of the company’s CLIA lab facility in Newark, California.
The next hammer blow 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, the company made two significant announcements last month involving membership of its Scientific and Medical Advisory Board. Also, the American Association of Clinical Chemistry (AACC) issued a press release stating that 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 this August.
Do you plan to attend the AACC meeting this year, and is Holmes’ speech one of your primary reasons? Please share your thoughts on the future for Holmes and Theranos in the comments below.