The U.S. Food and Drug Administration (FDA) recently announced that it
is taking steps to increase its oversight over certain diagnostic tests
used to help diagnose and treat patients.
Under the agency’s current regulatory framework, many laboratory
developed tests (LDTs), which are designed, manufactured and intended
to be used in a single laboratory, do not undergo premarket review. Accordingly,
their accuracy and reliability may not be supported by clinical tests.
As highlighted in an
FDA blog post, the agency has traditionally exercised enforcement discretion over LDTs.
However, these tests have recently grown more complex and high risk. Moreover,
while they were previously only used in conjunction with rare illnesses,
they are now being used to detect the risk for breast cancer and Alzheimer’s
disease. LDTs also frequently compete with tests that are approved by the FDA.
Accordingly, the FDA is proposing to establish an LDT oversight framework,
which would include pre-market review for higher-risk LDTs, such as those
that have the same intended use as FDA-approved or cleared companion diagnostics
currently on the market. Under its proposed guidance, enforcement of pre-market
review for other high risk and moderate risk LDTs would be phased in over time.
“Ensuring that doctors and patients have access to safe, accurate
and reliable diagnostic tests to help guide treatment decisions is a priority
for the FDA,” said FDA Commissioner Margaret A. Hamburg, M.D. “Inaccurate
test results could cause patients to seek unnecessary treatment or delay
and sometimes forgo treatment altogether. Today’s action demonstrates
the agency’s commitment to personalized medicine, which depends
on accurate and reliable tests to get the right treatment to the right