FDA warns two diagnostics players for marketing unapproved tests

SureView--Courtesy of Sure Genomics

Sure Genomics' dashboard "provides fascinating insights into personal strengths, weaknesses, aptitudes, and abilities," according to the company website.

The FDA just cracked down on it and another company, Solopap International Limited, for marketing unapproved diagnostics as it seeks to protect the public from questionable molecular tests.

Sandy, UT's Sure Genomics has apparently begun accepting preorders for the SureDNA test to sequence DNA, assess disease risks and determine the likelihood of drug interactions, all based on sample of saliva.

"We have conducted a review of our files, and have been unable to identify any Food and Drug Administration (FDA) clearance number for the Sure DNA test. We request that you provide us with the FDA clearance number for the SureDNA test. If you do not believe that you are required to obtain FDA clearance for the SureDNA test, please provide us with the basis for that determination," the agency wrote in a letter to the company's founder.

Meanwhile, Henderson, NV's Solopap is marketing its self-administered Solopap Home HPV&PAP Tests to diagnose those diseases via a cervical sample. It is available for purchase on PayPal, according to the letter.

In addition to the standard statement that the review of its files turned up empty, the FDA requested a sample lab report that provides the test results to medical practitioners.

The moves come as the agency prepares to extend its oversight to laboratory-developed tests pending finalization of a draft guidance. Its premarket approval jurisdiction is currently limited to those diagnostics whose analysis is performed outside of large centralized laboratories, which are governed by the so-called CLIA rules.

To counter critics representing providers of LTDs, like the American Clinical Laboratory Association, the FDA in November released a report of 20 case studies that buttress its desire for more regulation.

- read the letter to Solopap International Limited (PDF)
- read the letter to Sure Genomics (PDF)