Palo Alto, Calif.-based Theranos has faced an onslaught of media and federal attention since Thursday, following a page-one investigative report in the Wall Street Journal debunking the startup's claims it could perform more than 240 tests with a finger prick-worth of blood.
Here is an update of the Theranos aftermath.
1. Theranos is now only using its exclusive Edison technology to collect and test tiny "nanotainers" of blood for just one test, a person familiar with the manner told The Wall Street Journal in a report published Friday.
2. This move strips Theranos of the innovative idea it was founded on, which is based around the 31-year-old CEO and Founder Elizabeth Holmes' fear of needles.
3. WSJ reported Friday morning FDA inspectors made an unannounced appearance at Theranos headquarters and declared the nanotainers an unapproved medical device. The tiny vials must be approved by the FDA to use them again, according to the report. The company will also have to resubmit data for many of its proprietary blood tests because the data provided could not sufficiently prove accuracy, according to the report.
4. CMS is also auditing Theranos, though a CMS spokesperson declined to comment, according to the report.
5. Ms. Holmes confirmed in an interview on CNBC's "Mad Money" Thursday the company is "not even using our nanotainers except for FDA-cleared assays," which according to WSJ's Thursday report, is just one test. The company has submitted more than 100 test to the FDA for approval, but the WSJ reported the FDA has approved just one, for herpes.
6. Ms. Holmes said she was shocked by Thursday's hard-hitting WSJ report since the company had provided the newspaper with more than 1,000 pages of facts that directly refute claims made in the story. "This is what happens when you work to change things, and first they think you're crazy, then they fight you and then all of a sudden you change the world," she said on "Mad Money."
7. Thursday's report made claims the company inaccurately represented the use of its Edison technology, changed the website during the reporting of the article and gamed its CMS proficiency testing.
8. The report is based on interviews with four former employees, government employees, nurses and physicians familiar with the technology, as well as the company's outside lawyer and general counsel. Ms. Holmes declined interview requests for more than five months.
9. Theranos called the article factually and scientifically inaccurate, as well as the sources unreliable. It said the newspaper even declined a demonstration of its technology.
10. WSJ backed the article, and a spokeswoman issued a statement that it "fully stands by Thursday's article about Theranos, which was richly sourced and thoroughly researched." The spokeswoman also said it has tried since April to visit Theranos offices to see the technology.
More articles on leadership and management:
Week in review: 8 biggest healthcare stories this week
6 latest layoffs in healthcare
Datu Health closes headquarters, eliminating 42 jobs: 3 things to know