Laboratory-developed tests played a critical role during the COVID-19 pandemic. In fact, most current molecular tests have been developed as laboratory-developed tests, outside the strict regulatory framework of the U.S. Food and Drug Administration (FDA).

This doesn’t mean that the laboratory-developed test landscape is a kind of scientific wild west with no regulatory scrutiny. In fact, the process, which has been regulated since 1988 by CLIA, must follow stringent guidelines and best practices.

Under the CLIA regulations, clinical laboratories can modify FDA-approved tests, and develop their own tests, as long as they follow the requirements to validate the performance and characteristics of the LDT.1

Laboratories must establish and validate all performance specifications before initiating patient testing. In addition to accuracy, precision, specificity, and sensitivity, laboratories must also establish:

  • Reportable range
  • Reference range
  • Appropriate calibration and quality control methods
  • Procedures for maintenance and function checks
  • Specimen integrity criteria

Laboratories developing LDTs must also provide a statement indicating that the specifications were established by the organization that developed the test. And they must also provide a statement indicating that the test has not been cleared by the FDA.

Best Practices for Laboratory-Developed Tests

While there are specific regulations that laboratories must follow in creating a laboratory-developed test, there are also a set of best practices that underlie these rules that will help labs create a viable test, including:

  • Having a written procedure describing how validation studies were performed
  • Establishing criteria for acceptability and the retention of raw data, conclusions, and laboratory director approval
  • Developing and maintaining a detailed procedure manual for the test
  • Enrolling in proficiency testing or developing testing to measure accuracy and reliability
  • Retaining detailed documentation of all test activities

More fundamentally, before even embarking on the road to creating an LDT, laboratories must establish the clinical utility of the test, by answering one simple, yet critical question: How will the results of the test change the way the doctor treats the patient?

If the answer is, in fact, it will positively change or improve the way a doctor treats a patient, that’s only the first step. Ongoing peer review and published clinical studies will help to further clarify this answer and establish the test’s utility. It is also becoming a critical way for LDTs to receive reimbursement from payors.

Reimbursement has become increasingly complicated, so having a well-thought-out, realistic reimbursement strategy is critical. In today’s healthcare landscape, a test that is not reimbursed could find a tough road to acceptance by providers and patients alike, no matter how it improves patient outcomes.

Laboratory-developed tests offer labs important opportunities to improve patients’ lives and increase the bottom line.

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1. “Laboratory Developed Tests: Greater Role Leads to Increased Federal Oversight.” COLA’s Insights. November/December 2015.

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