Biden and members of industry who took part in the summit, which included Stanford Health Care CEO Amir Dan Rubin and Capital Blue Cross CEO Gary St. Hilaire, saw firsthand Theranos' laboratory as well as the proprietary systems on which it runs its finger-stick blood tests. In addition, the group toured the manufacturing facility where its proprietary systems are manufactured.
Theranos' tests are 50% or more below the Medicare reimbursement rate. The company offers tests ranging from full fertility panels ($35) to simple cholesterol tests ($2.99). It also espouses transparency in lab testing, including committing to FDA review of all of its laboratory-developed tests and publishing its prices, lab proficiency testing scores, customer satisfaction scores, guest visit times and more.
Theranos has attracted attention for both the ambition of its mission and the precociousness of its founder and CEO, Elizabeth Holmes, reports Inc. Holmes dropped out of Stanford University during her sophomore year to start the company at age 19. "By dramatically cutting the costs and inconvenience of blood work, and by making results available directly to patients, Theranos is aiming to help detect disease earlier, when treatment may be more effective," writes Inc. Editor at Large Kimberly Weisul.
FDA recently cleared Theranos' HSV-1 test as well as the finger-stick blood-test technology and underlying system on which the test is run, and approved a waiver that paves the way for putting Theranos' tests in the field at point of care, a major milestone for the company.
"It is a tremendous honor to have Vice President Biden visit Theranos and participate in a preventive health care summit," said Holmes. "I convened this roundtable as a call to action. Leaders in health must collectively come together because that's the only way that we'll change this health care paradigm from one focused on reactive care to one focused on preventive care. Nobody knows that as well as the Vice President, who has spent his entire career taking bold action to improve people's lives." Holmes added, "A new era of preventive care can transform our economy, as people undertake less costly interventions when they're still healthy instead of expensive interventions when it's too late to fundamentally change outcomes. Our discussion focused on these issues and identified concrete actions each of us can take with our organizations and through public policy to facilitate the early detection and prevention of disease."
Holmes has come under some criticism from competitors in the IVD ecosystem for not publishing peer-reviewed studies of its work, a common industry practice. When asked about this, Holmes typically answers that Theranos is submitting each of its tests for FDA approval, which she describes as the gold standard for determining efficacy and user requirements, according to Inc. Holmes has also said that she will reveal more information about the company on her timetable, not when her competitors request it.
The White House has been a staunch advocate of preventive healthcare practices, which are among the provisions of the Affordable Care Act, aka Obamacare. IVD devices play a key role in early detection of disease, and the global $55.9 billion industry is projected to reach a value of $74.6 billion by 2020, as reported earlier this year in PlasticsToday. Moderate growth is anticipated for IVDs in developed countries, with an increasing middle class in Brazil, China and India fueling greater demand.
On the materials side, plastics are estimated to have a 90% market share in point-of-care IVD devices.