Rep. Slaughter, Doctors, Scientists, Patient Advocates, and Academics Hold Roundtable Discussion on FDA Oversight of Laboratory Developed Tests

WASHINGTON – November 18, 2014 — Today, the American Cancer Society Cancer Action Network, the American Heart Association, and the Ovarian Cancer National Alliance, in cooperation with Rep. Louise M. Slaughter (D-NY), held a roundtable discussion on the Food and Drug Administration’s (FDA) draft regulatory framework for Laboratory Developed Tests (LDTs). The panel of doctors, scientists, and academics discussed their support for increased FDA oversight over LDTs to provide more accurate, effective care to patients.

LDTs are a subset of in vitro diagnostic tests that have neither gone through FDA’s pre-market clearance or review to ensure safety and effectiveness, nor are they subject to FDA’s post-market oversight.  As LDTs are being used more frequently to guide medical treatment, especially to diagnose and guide the treatment of potentially life-threatening conditions, the FDA has proposed a risk-based approach to the oversight of LDTs that can support new advances in technology and promote patient care by supporting timely access to safe, effective, and innovative technologies. FDA’s draft guidance, released on October 3rd, is currently open for public comment by interested stakeholders.

In June 2013, Rep. Slaughter lobbied the Office of Management and Budget and the Federal Drug Administration for stronger federal oversight to ensure that LDTs are safe and reliable as doctors and patients make crucial health care decisions based on their results.

“Laboratory developed tests are revolutionizing patient care, but in order for them to be effective, we must make sure that the tests are valid and safe,” Congresswoman Slaughter said. “I am glad that support has been building for FDA oversight of LDTs, and I am thankful for my friends at the American Cancer Society, the American Heart Association, and the Ovarian Cancer National Alliance for their support of making medical care safer for all Americans.”

“Early LDTs were relatively simple, low-risk tests like blood counts, but over the years we have seen a tremendous growth in the sophistication of tests and their importance in patient decision making,” said Christopher Hansen, President of the American Cancer Society Cancer Action Network. “It’s more critical than ever that patients and doctors have confidence that these tests are both safe and work as advertised.”

The American Cancer Society Cancer Action Network, the nonprofit, nonpartisan advocacy affiliate of the American Cancer Society, is the nation’s leading cancer advocacy organization that works to make cancer issues a national priority.

“Our growing understanding of genetics’ role in disease has helped to flood the market with many new tests designed to assess the risk for cardiovascular disease,” said American Heart Association President Elliott Antman, M.D. “Yet high-risk tests remain on the market with no regulation and patients are using them to assess their potential for disease, possibly causing their doctors to take action based on inaccurate or misleading results.  FDA’s recently proposed draft oversight framework  will ultimately ensure that diagnostic and genetic tests will yield the safe, effective and reliable results that patients and their doctors can trust.”

The American Heart Association is the nation’s oldest and largest voluntary organization devoted to fighting cardiovascular diseases and stroke. They fund innovative research, advocate for stronger public health policies, and provide tools and information to save and improve lives.

“Unfortunately, our community has experienced first-hand the danger of a bad test being offered to patients without oversight,” said Laura Koontz, Ph.D, Director of Policy of the Ovarian Cancer National Alliance. “We applaud the steps FDA is now taking to verify lab developed tests, ensure their safety and effectiveness, and keep bad tests, like OvaSure, from harming patients.”

The Ovarian Cancer National Alliance connects survivors of ovarian cancer, women at risk, caregivers, and health providers with information and resources. They ensure that ovarian cancer is a priority for lawmakers and agencies in DC and throughout the country.

Involved in the discussion were:

Congresswoman Louise M. Slaughter (D-NY)
Len Lichtenfeld, M.D., Deputy Chief Medical Officer for the American Cancer Society, Moderator
Elizabeth Mansfield, Ph.D, Deputy Office Director for Personalized Medicine, Office of In Vitro Diagnostics, Food and Drug Administration
Judith Yost, M.A., M.T. (ASCP), Director, Division of Laboratory Services, Center for Medicare and Medicaid Services
Richard Schilsky, M.D., Chief Medical Officer, American Society of Clinical Oncology
Laura Koontz, Ph.D, Director of Policy, Ovarian Cancer National Alliance
For More Info, Contact
Alissa Crispino or Steven WeissEmail: [email protected] or [email protected]
Phone: 202-661-5772 or 202-661-5711

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