New recommendations for strengthening oversight of laboratory-developed tests

Sep 25 2009

Three-tiered approach would categorize new LDTs by potential risk

The College of American Pathologists today announced new recommendations for strengthening oversight of laboratory-developed tests (LDTs), proposing a three-tier 'risk-based' system that would protect patients by ensuring every laboratory developed test is reported to an oversight body, and instituting a graduated system of review based on a test's potential risk to patients.

"While the preponderance of laboratory developed tests present relatively low risk to patients, the increasing use and complexity of some LDTs underscores the need for increased oversight," said Jared N Schwartz, MD, Ph.D., FCAP, president of the College of American Pathologists. "CAP's risk-based model employs a public private partnership to address oversight of these tests in an inclusive, systematic way."

CAP's proposed changes would incorporate oversight of claims of clinical validity, and would specify scientific and regulatory standards to be applied to all LDTs. Risk would be determined based on claims made, potential risk to patients, and the extent to which its results could be used in the determination of diagnosis or treatment.

The College believes optimum oversight would be achieved by applying a risk-based classification (low-, moderate-, or high-) to every LDT; strengthening CLIA accreditation standards on labs using low- and moderate-risk LDTs, and requiring FDA review of all high-risk LDTs.

"Laboratory-developed tests (LDTs) represent some of the most innovative clinical testing being offered to patients today, and have a long history of advancing patient care as safe and effective laboratory services," Schwartz said. "Strengthening their oversight ensures they will remain one of the key tools medical laboratories use to answer increasingly complex questions."

http://www.cap.org/