In its report, the FDA highlighted false-positives and false-negatives among several potentially harmful test results. Among the LDTs covered in FDA’s report are ovarian cancer screening tests, Lyme disease and whooping cough diagnostics, and noninvasive prenatal tests to detect fetal chromosomal abnormalities. “Other LDTs provided information with no proven relevance to the disease or condition for which they are intended for use, while still others are linked to treatments based on disproven scientific concepts,” the agency noted. “In addition to patient harm, inaccurate or unreliable tests can be costly to society.”
The FDA last year said it would begin regulating LDTs through a process the agency plans to phase in over time. “FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling,” Peter Lurie, associate commissioner for Public Health Strategy and Analysis at FDA, wrote in a November 16 blog post.
Hat tip: The Wall Street Journal