FDA Fires Its First Shot at Laboratory Developed Tests

How can a simple blood test magically become “an unapproved medical device”? Action Alert!
Last week, the FDA sent a letter to Pathway Genomics stating that the company’s non-invasive cancer screening test is a medical device being marketed without FDA approval. The FDA also contended that the “device” lacked sufficient clinical support.
The FDA claims that the cancer test meets the definition of a medical device because the company ships blood collection tubes—medical devices—for use with the test. As a medical device, the test is supposedly subject to FDA scrutiny.
Pathway Genomics responded in a statement that the test in question is a laboratory developed test, not a medical device, and therefore falls under the jurisdiction of the Centers for Medicare and Medicaid Services (CMS), not the FDA.
As we reported last year, laboratory-developed tests (LDTs) are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, and companion diagnostics. LDTs are vital tools for personalized medicine because labs can even create custom diagnostic tests.
The controversy started last year when the FDA released a draft guidance proposing to treat LDTs as medical devices, requiring pre-market approval in some cases. This led some members of Congress to accuse the FDA of overstepping its authority.
For example, Rep. Michael C. Burgess (R-TX), the House Energy and Commerce Health Subcommittee’s vice chair, said in a statement that the FDA’s regulation of LDTs in this guidance “is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.” In subsequent exchanges with the FDA, Rep. Burgess also pointed out that LDTs are overseen by CMS and do not require additional oversight by the FDA.
This is, unfortunately, a common FDA maneuver—issuing guidance documents to accomplish what they can’t get away with if they go through the normal rulemaking process.
This first letter to Pathway Genomics could be the FDA testing the waters, seeing how far they can get in illegally regulating LDTs.
If the FDA gets away with this, it could have huge implications for consumer access to these tests. LDTs are the future of medicine. People are already able to test for and spot cancers long before they manifest themselves using current methods. These tests are improving at a rapid rate. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.
LDTs are not only the future of general medicine—they are also the future of individualized medicine, which is an exciting and important development in its own right. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—this information could not be gathered and analyzed otherwise.
Consider also our earlier coverage of Theranos, the exciting new blood testing company. Its technology will allow you to walk into your Walgreens, with or without a prescription, and get blood test results the same day with astounding accuracy rates and at very low cost. Developments like this empower consumers to take a more active approach in monitoring their own health.
LDTs are different from other diagnostic tests in that LDTs don’t require any sort of standardized premarket controls, whereas other diagnostic tests need to demonstrate safety and effectiveness to the FDA using analytical studies; some must be taken through the full FDA approval process at astronomical expense. If the FDA succeeds in broadening its regulatory authority to include LDTs, innovation in this field is sure to be crushed, medicine will be held back, millions of Americans will die unnecessarily, and medical costs will rise.
Action Alert! Send a message to the FDA emphasizing that they lack regulatory authority to regulate LDTs. If they want to change that, they must follow a formal rulemaking procedure so the public will have a voice in the matter, instead of skirting the law by issuing a guidance. Please send your message immediately.