The ASCO statement corroborates the need for regulation of laboratory-developed tests, which are increasingly being used to guide personalized treatment in oncology as well as other therapeutic areas.
ASCO supports the FDA's Framework Guidance that proposes a risk-based approach to regulation of laboratory-developed tests (LDTs), particularly genomic tests that, increasingly, are being used to guide therapy selection for patients with cancer. Failure of such tests to perform as intended can lead to patients receiving an inappropriate and potentially harmful treatment or, alternatively, not receiving a treatment that has the potential to benefit them.
Prevailing regulations that apply to LDTs offered for clinical use, namely CLIA, do not assess the safety and effectiveness of LDTs offered by laboratories. Rather, they determine that the laboratory follows generally accepted standards for good laboratory practices. Under CLIA, laboratories are required to demonstrate the analytical validity of the tests they offer, that is, that the test accurately and reproducibly measures what it claims to measure. However, CLIA does not evaluate the clinical validity of a test, ie, the test’s ability to detect the clinical condition for which the test is intended. Nor does CLIA evaluate the clinical utility of the test, ie, whether or not patient outcomes are improved by using the test.
Press release from ASCO: http://bit.ly/1og3UPg