Hot startup Theranos dials back lab tests at FDA's behest; firm has stopped collecting tiny vials of blood drawn from finger pricks for all but one of its tests - @WSJbreakingnews
Walgreens won't open new Theranos blood-testing centers until startup resolves questions, official says - @WSJbreakingnews
FDA inspectors: Theranos blood vials are an 'uncleared medical device' - @WSJbreakingnews
US health regulators investigating complaints about laboratory and research practices at Theranos, sources tell @WSJ
Federal government says blood-testing company Theranos' Newark, Calif., facility poses 'immediate jeopardy to patient safety' - Verge
During Federal health inspection of Theranos lab, authorities uncovered 5 major infractions that violate conditions of participation in Medicare program; company has 10 days to submit plan to correct deficiencies - WSJ
Theranos is an American privately-held health-technology and medical-laboratory-services company based in Palo Alto, California. Theranos has claimed to have developed a blood-testing device named Edison that uses a few drops of blood obtained via a finger-stick rather than vials of blood obtained via traditional venipuncture, utilizing microfluidics technology. Its founders have raised over $400 million from investors, valuing the company at $9 billion, without their testing device ever being subject to peer-reviewed study.
On October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, revealed that Theranos's flagship Edison testing device might provide very inaccurate results. Theranos attacked the Wall Street Journal, but did not refute any of the allegations. On 28 October 2015, the Food and Drug Administration also revealed major shortcomings in the company's practices and ordered Theranos to stop using its Edison device, which it had neither tested for accuracy nor approved, contrary to the company's previous claims. Theranos was ordered to limit its use of Edison to one of the 200 tests it offers. The Arizona Department of Health Services has found issues in the company's other laboratory.
On December 2, The Washington Post revealed the exploration of a partnership with the US military had led to issues being found with the Edison device and a request that the FDA investigate. This request was denied by United States Marine Corps General James Mattis after Holmes's intervention. Mattis later joined the Board of Directors of Theranos.
Theranos has also claimed to have partnerships with GlaxoSmithKline and Pfizer, which both GlaxoSmithKline and Pfizer have denied. The company also claimed successful venture capital firm Draper Fisher Jurveston had invested in them, but company principal Steve Jurvetson clarified that it had provided the company's first $500,000 seed investment and nothing more.
After the revelations of October 2015, Theranos's partner Walgreens suspended their plans to rollout Theranos's testing services in their stores, and it was revealed that Safeway had already cancelled a $350 million agreement to use Theranos's testing technology amid doubts about its accuracy. The Cleveland Clinic hospital, recently announced as a Theranos partner, distanced itself from Theranos's technology and denied they had verified its accuracy. Customers have reported writing to Theranos querying inaccurate results, receiving no response.
On October 27, 2015, Theranos claimed to have data verifying the accuracy of its Edison testing device and announced it would publish it. As of January 7, 2016, it has not done so.
Walgreens won't open new Theranos blood-testing centers until startup resolves questions, official says - @WSJbreakingnews
FDA inspectors: Theranos blood vials are an 'uncleared medical device' - @WSJbreakingnews
US health regulators investigating complaints about laboratory and research practices at Theranos, sources tell @WSJ
Federal government says blood-testing company Theranos' Newark, Calif., facility poses 'immediate jeopardy to patient safety' - Verge
During Federal health inspection of Theranos lab, authorities uncovered 5 major infractions that violate conditions of participation in Medicare program; company has 10 days to submit plan to correct deficiencies - WSJ
Theranos is an American privately-held health-technology and medical-laboratory-services company based in Palo Alto, California. Theranos has claimed to have developed a blood-testing device named Edison that uses a few drops of blood obtained via a finger-stick rather than vials of blood obtained via traditional venipuncture, utilizing microfluidics technology. Its founders have raised over $400 million from investors, valuing the company at $9 billion, without their testing device ever being subject to peer-reviewed study.
On October 16, 2015, The Wall Street Journal, quoting many unnamed current and former employees, revealed that Theranos's flagship Edison testing device might provide very inaccurate results. Theranos attacked the Wall Street Journal, but did not refute any of the allegations. On 28 October 2015, the Food and Drug Administration also revealed major shortcomings in the company's practices and ordered Theranos to stop using its Edison device, which it had neither tested for accuracy nor approved, contrary to the company's previous claims. Theranos was ordered to limit its use of Edison to one of the 200 tests it offers. The Arizona Department of Health Services has found issues in the company's other laboratory.
On December 2, The Washington Post revealed the exploration of a partnership with the US military had led to issues being found with the Edison device and a request that the FDA investigate. This request was denied by United States Marine Corps General James Mattis after Holmes's intervention. Mattis later joined the Board of Directors of Theranos.
Theranos has also claimed to have partnerships with GlaxoSmithKline and Pfizer, which both GlaxoSmithKline and Pfizer have denied. The company also claimed successful venture capital firm Draper Fisher Jurveston had invested in them, but company principal Steve Jurvetson clarified that it had provided the company's first $500,000 seed investment and nothing more.
After the revelations of October 2015, Theranos's partner Walgreens suspended their plans to rollout Theranos's testing services in their stores, and it was revealed that Safeway had already cancelled a $350 million agreement to use Theranos's testing technology amid doubts about its accuracy. The Cleveland Clinic hospital, recently announced as a Theranos partner, distanced itself from Theranos's technology and denied they had verified its accuracy. Customers have reported writing to Theranos querying inaccurate results, receiving no response.
On October 27, 2015, Theranos claimed to have data verifying the accuracy of its Edison testing device and announced it would publish it. As of January 7, 2016, it has not done so.