publication date: Sep. 12, 2014


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By Will Craft

The American Association for Cancer Research urged FDA to regulate high-risk laboratory-developed tests, a category of assays that has escaped scrutiny because of loopholes in the regulatory process.

Normally, FDA requires that diagnostic tests developed by manufacturers adhere to three measures: analytic validity, clinical validity, and clinical utility. However, laboratories can get around this requirement by using laboratory-developed tests, or LDTs.

LDTs are designed and manufactured for use in a single laboratory, but can go to market without obtaining FDA approval as long as the laboratory meets other requirements—called the Clinical Laboratory Improvement Amendments, which are unrelated to the manufacturing and testing of the LDTs.

The loophole persists because FDA chooses not to actively regulate LDTs, the AACR said in an article published Sept. 9 in Clinical Cancer Research.

“The FDA chose not to exercise its regulatory authority in the past largely because LDTs were typically well-established diagnostic test procedures (e.g., urine analysis, microbiology cultures, blood analysis). However, some LDTs being developed today run the risk of being ineffective and exposing patients to inappropriate clinical decision-making if they are not subject to the same scrutiny given to FDA-approved tests,” wrote authors Charles Sawyers and Laura van ‘t Veer.

Sawyers is chair of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center and a former president of AACR. Van’t Veer is leader of the Breast Oncology Program and associate director of applied genomics at UCSF Helen Diller Family Comprehensive Cancer Center.

The paper stresses the need for regulation of LDTs, but recognizes the … Continue reading 40-34 AACR Urges FDA to Regulate High Risk Lab-Developed Tests

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