Two leading cancer research advocacy groups are calling on Congress to pass a key diagnostics reform bill, arguing that laboratory-developed tests (LDTs) used to determine treatment for cancer patients are not regulated closely enough and lead to unreliable test results that can impede access to safe and effective treatment.
Lisa Lacasse, president of the American Cancer Society Cancer Action Network and Jeff Allen, president and CEO of Friends of Cancer Research, wrote in an op-ed published in STAT Wednesday (Nov. 30) that FDA currently only regulates tests that are used in multiple labs or health care facilities, but it leaves out LDTs. The solution, they say, is passing the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bill that would create a risk-based regulatory framework for LDTs and would also establish a user fee program for in-vitro clinical tests.
VALID is sponsored by Rep. Diana DeGette (D-CO) in the House and Richard Burr (R-NC) in the Senate. Members of the Senate health committee included VALID in their user fee package that cleared the committee in June, but the measures — and many other FDA reforms — were ultimately left out of the user fee bill that Congress passed at the end of September. Supporters of the bill have since lobbied for its inclusion in Congress’ expected year-end bill.
“The bill is good for industry, laboratories, providers and, most importantly, patients,” the cancer advocacy groups wrote. “An individual’s best chance to fight cancer should never be affected by something as easily preventable as a faulty diagnostic test. Congress has the opportunity today to do what is right for patients.”
Lacasse and Allen emphasize that a growing number of targeted cancer treatments rely on biomarker tests to determine a patient’s prognosis and which drugs are best for the patient’s disease.
“With the advent of targeted therapies, the accuracy of a diagnostic test is critical,” they wrote. “Yet oversight of such tests has not kept pace with innovation.”
As an example of the consequences of a lack of LDT oversight, Lacasse and Allen point to the high-profile case of Theranos, a startup spearheaded by Elizabeth Holmes who claimed to be able to diagnose myriad health conditions with a drop of blood. Contrary to Holmes’ claims, the technology did not work, and thousands of people received faulty tests for serious conditions. Holmes was recently sentenced to more than 11 years in prison for four counts of criminal fraud.
Lacasse and Allen cite a study from the American Journal of Clinical Pathology, which showed that LDTs with the same intended use as FDA-approved tests had significant variability in their results. They say unreliable test results can impede cancer patients’ ability to access safe and effective treatments.
They wrote that the VALID Act would tighten regulations for LDTs, ensuring that patients have access to reliable tests moving forward. They also underscore that the bill would allow for “detailed flexibilities” that would ensure labs can meet individual needs of patients without delaying care.
VALID could still get passed by December in a year-end package, but a source close to the negotiations told Inside Health Policy in September that LDT regulation could be too divisive to get done this year.
FDA commissioner Robert Califf said late last month that the agency would consider pursuing federal rulemaking for LDT reform in the absence of legislation. However, a lawyer told IHP that FDA doesn’t have the authority to accomplish such a drastic overhaul without going through Congress. — Lia DeGroot (email@example.com)