publication date: Nov. 20, 2015

FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health 

 

Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.

The case studies included LDTs such as the Target Now cancer biomarker test, developed by Caris Life Sciences Inc.; the Oncotype DX HER2 RT-PCR breast cancer test; and the Duke University Chemotherapy Assessment genetic tumor assay.

The report also examined tests used to screen women for ovarian cancer, to identify breast cancer patients that have HER2 receptors, HPV genetic exams, a leukemia therapy companion diagnostic, and a genetic mutation test to guide melanoma treatment—as well as tests for whooping cough, Lyme disease, prenatal tests, and others.

“The costs of this lack of oversight are staggering,” said Peter Lurie, associate commissioner for public health strategy and analysis, in an FDA blog post about the report and why the agency should oversee LDTs.

“We were able to derive an estimate of the public health cost for five of the 20 cited tests,” Lurie wrote Nov. 16. “For the CARE Clinical Autism Biomarkers Test alone (one of those cited in the report), FDA economists estimated a total public health cost of $66.1 million.”

FDA issued a draft … Continue reading 41-43 FDA Lists Potentially Avoidable Harms in 20 LDT Case Studies, Including Tests from Duke, Caris and Genomic Health

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