The effectiveness of "liquid biopsy" is not sufficiently substantiated
The FDA is concerned about the safety of screening tests for early detection of cancer
The US Food and Drug Administration (FDA) has sent a notification letter to Pathway Genomics, writes Drug Discovery & Development (FDA Sends Warning to Startup Selling Suspicious Cancer Test). The department stressed that they want to ask a few questions to the head of the company, Jim Plante, regarding the data used in the promotion of screening tests.
Earlier, Pathway Genomics introduced a new test for early detection of oncological diseases on the market. According to the manufacturer, the screening test uses liquid biopsy technology to detect tumor DNA particles in the blood of a healthy patient who has a high risk of developing cancer.
The FDA letter notes that the scientific articles used by Pathway Genomics to promote its product talk about the possibility of detecting tumor DNA particles in the blood of already diagnosed cancer patients. According to the FDA, it is unclear how such materials can confirm the possibility of detecting tumor particles in undiagnosed patients.
In addition, the experts of the regulatory authority had questions about the company's advertising materials, since there is no record of the registration of the test, which is a mandatory requirement for the sale of medical products. The department emphasizes that these tests may pose a danger to patients due to a lack of scientific information about them.
Currently, Pathway Genomics provides an opportunity to pass a test for early detection of cancer for $ 299-699.
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30.09.2015