Theranos CEO Courts Controversy at Clinical Chemistry Meeting

Elizabeth Holmes will explain Theranos's testing methodology at the American Association for Clinical Chemistry annual meeting, but some question the decision to give her a podium.

Nancy Crotti

The founder and CEO of secretive and embattled Theranos is scheduled to discuss the science behind the company's proprietary blood-testing technology at a prestigious clinical laboratory conference in Philadelphia on Monday.

Elizabeth Holmes' presentation at the American Association for Clinical Chemistry annual meeting will compare reproducibility and correlation data for various tests comparing Theranos's finger-stick blood collection and storage device with traditional blood-drawing methods, according to the conference program.Holmes will also discuss the methodology that Theranos uses for its diagnostics testing platform, and "share data to demonstrate the precision and accuracy of these chemistry, immunochemistry, hematology, and molecular assays (traditionally performed on separate instruments) using their analytical testing platform, including a novel molecular test for the Zika virus," the program says.

Theranos, which faces sanctions by CMS and is under investigation by the U.S. Department of Justice, has been very secretive about its technology and methodology. The company also faces consumer lawsuits.

Holmes' appearance is provoking controversy, according to a report by STAT, and curiosity as well.

"Would you have Al Capone come and talk about his novel accounting practices?" Geoff Baird, a clinical pathologist at the University of Washington, rhetorically asked STAT.  "Is it acceptable to allow someone to talk about science if they've used that science so horribly inappropriately?"

Others among the 20,000 or so conference attendees will likely be curious to see this latest step in Theranos's attempts to right the ship.

The Palo Alto, CA-based company recently appointed Dave Wurtz, formerly senior director for regulatory affairs, quality, and compliance at Thermo Fisher Scientific, to be vice president of regulatory affairs and quality. Attorney Daniel Guggenheim, former assistant general counsel for regulatory and compliance at healthcare giant McKesson in San Francisco, was named chief compliance officer.

Both will report to Holmes, whom CMS banned from the business for two years. Theranos noted that it has 60 days from the July 7 imposition of sanctions by CMS to appeal the agency's decisions. Those sanctions include fines and cancelling reimbursements for the Newark, CA, lab that was the center of CMS's investigation. Forbes once listed Holmes as being worth $4.5 billion during Theranos's better days. In June, it revised that estimate to zero.

After her presentation, Holmes is scheduled to answer questions submitted in real-time by audience members. 

Nancy Crotti is a contributor to Qmed.