Elizabeth Holmes July 2015 WSJ Op Ed Supporting FDA Review of All Lab Tests

https://www.wsj.com/articles/how-to-usher-in-a-new-era-of-preventive-health-care-1438125343


How to Usher In a New Era of Preventive Health Care
People should be able to get any lab test on their own. Waiting for symptoms and a doctor’s order may be too late.

Laboratory tests drive 70% of all clinical decisions in health care. They’re used to determine whether a patient should start taking medication and, if so, which one. They help doctors decide whether a patient should undergo medical procedures or be admitted to the hospital. And they’re used to identify an individual’s risk of developing health conditions such as diabetes or heart disease.

Yet many of us get lab tests only when we’re showing symptoms, which means we may already be sick. And too many of us find out we’re sick when it’s too late to change the course of these conditions.

It’s time to move away from reactive health care. Individuals instead need to be empowered to be proactive, take control of their own health, and work with physicians to detect diseases early or before they take hold. This empowerment will usher in a new era of preventive health care. There are several steps that can help us get there:

All lab tests should undergo review by the Food and Drug Administration. Given the pivotal role of labs in medicine, consumers need to trust the quality and accuracy of the tests they get. The FDA sets the gold standard for quality assurance. Its review is data-driven, objective and uniquely rigorous.

I know this firsthand because Theranos, the company I founded, voluntarily committed to submit all of its lab tests for review starting in 2013. On July 2, the FDA cleared the first of those tests, for herpes simplex virus 1, and the associated finger-stick blood-test technology and underlying system on which our tests are run.

The review included an examination of the company’s systems, methods, chemistry, hardware and software. The FDA scrutinized everything from our collection devices to our analytics. It analyzed study data from more than 800 subjects and assessed our test and test system’s performance outside of clinical laboratories when subjected to a broad range of environmental influences.

This oversight should be the norm. It isn’t. Traditional medical-device manufacturers must submit their lab tests to FDA for review before selling their products. Laboratories that make their own tests aren't required to do so.

The FDA recently proposed requiring laboratories to submit their tests for review. The proposal should be adopted. And Congress should provide the agency with the funds to exercise this oversight.

Innovation needs to be unleashed. The improvements that technology and innovation could bring to health care are limited only by the imagination. But the technological progress that brought us the personal computer, the smartphone, the car was powered by consumer choice and free access to information in the market. That will be true in health care as well.

Our data shows that at least 40% of people today don’t get a lab test when a physician orders it for them, often because the patient can’t afford it. No one should have to forgo care because he can’t afford to get a lab test or can’t figure out how much it costs ahead of time.

Empowering individuals to engage in their own health, including through ordering their own lab tests, means the prices of these services will increasingly become transparent. Transparent pricing and consumer engagement allow markets to function, driving competition and innovation for higher-quality and lower-cost services.

This isn’t just an issue for consumers. Federal and state governments pay tens of billions for lab tests through Medicare and Medicaid. Reducing their costs through competition and innovation will pay big benefits for taxpayers. Accessible testing including at lower cost will also help shift the health-care paradigm to early detection and prevention.

Diagnostic information needs to be more accessible. Getting lab tests today typically requires a doctor’s order, determining insurance eligibility, sometimes multiple appointments, time off from work, and waiting for the results to come back.

Technological breakthroughs can go a long way toward removing some of these barriers. An example: On July 15 the FDA approved a waiver that allows Theranos to run its herpes simplex virus 1 test at its retail Wellness Centers, where samples can be analyzed on the spot instead of being shipped to a centralized facility, and results reported quickly.

Convenience also matters. the more accessible care locations become, and the longer hours they are open, the better people can take control of their own health.

Finally, public policy has an important role to play in furthering the goal of patient-centered health care. I recently worked with leaders in Arizona to pass a state law that allows individuals to order and pay for any laboratory test without having to justify a health concern or rely on insurance eligibility. The law also provides protections for physicians so they can work with patients in a preventive manner around direct-access tests. Individuals across the country should have the same freedom.

You have a fundamental right to access information about your own health. And you should be able to access that information when it matters most—when there is still time to change your life, and the lives of those you love, for the better.

The answers to our challenges in health care lie in the individual. By empowering individuals to engage in their own health, we can build a preventive care system in America—and a world in which fewer people have to say goodbye too soon.

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Ms. Holmes is the founder and CEO of Theranos, a consumer health-technology and medical-laboratory-services company.