FDA Releases Report Listing 20 Potentially Dangerous Lab Tests
In the ongoing battle over the regulation of laboratory developed tests (LDTs), the Food and Drug Administration on Nov. 16 issued a report detailing the potential risk of allowing some tests to go unregulated by the agency. The FDA has proposed to regulate LDTs along the lines it does medical devices, with particular scrutiny to those assays it considers more likely to harm patients. The laboratory sector has asserted that CLIA regulations would suffice for most tests, and suggested that updates to CLIA would allay most of the FDA’s concern. In its report, the agency issued 20 different case studies of LDTs that while compliant with CLIA regulations, did not require approval of the FDA. A couple of the tests have been withdrawn or not brought to market, but most are currently available commercially. According to the FDA report, they "illustrate, in the absence of compliance with FDA requirements, that these products may have caused or have caused actual harm to patients. In some cases, due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which […]
In the ongoing battle over the regulation of laboratory developed tests (LDTs), the Food and Drug Administration on Nov. 16 issued a report detailing the potential risk of allowing some tests to go unregulated by the agency.
The FDA has proposed to regulate LDTs along the lines it does medical devices, with particular scrutiny to those assays it considers more likely to harm patients. The laboratory sector has asserted that CLIA regulations would suffice for most tests, and suggested that updates to CLIA would allay most of the FDA's concern.
In its report, the agency issued 20 different case studies of LDTs that while compliant with CLIA regulations, did not require approval of the FDA. A couple of the tests have been withdrawn or not brought to market, but most are currently available commercially.
According to the FDA report, they "illustrate, in the absence of compliance with FDA requirements, that these products may have caused or have caused actual harm to patients. In some cases, due to false-positive tests, patients were told they have conditions they do not really have, causing unnecessary distress and resulting in unneeded treatment. In other cases, the LDTs were prone to false-negative results, in which patients' life-threatening diseases went undetected. As a result, patients failed to receive effective treatments."
Among the tests disputed by the FDA include assays to determine the risk for ovarian cancer; a test for whooping cough; tests to help guide treatment of patients with breast cancer, prostate cancer and melanoma; non-invasive prenatal testing; and vitamin D deficiency testing, among others.
The American Clinical Laboratory Association was immediately dismissive of the report.
"These so-called case studies are not representative of the thousands of LDTs utilized on a daily basis by providers to positively impact patient care," the ACLA said in a statement.
Laboratory Industry Report will delve more deeply into the FDA report—along with responses from laboratories— in its next issue.
Takeaway: The Food and Drug Administration is ratcheting up pressure regarding the regulation of laboratory developed tests.
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