The firm said net product revenues fell 11 percent year over year in the fourth quarter.
The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.
The company attributed the lower revenue growth to lower volume growth in diagnostics, which is expected to continue for the rest of the year.
The agency informed the public that most PGx tests haven’t been reviewed by the agency, and they should refer to information in FDA approved product labels when using such tests.
The protocol could lead to greater regulatory harmonization in Europe, where every country has its own national legislation covering genetic testing.
CEO Peter Foley said that the company also intends to invest more in its consumer testing platform and will build out its data science team to improve the results it delivers to patients.
Makers of genetic health risk tests will only need one FDA review before commercializing tests, with some exceptions.
A Color Genomics collaborator reported that nearly half of first-degree relatives who were invited for reduced-cost testing in cancer-related genes opted to participate.
A number of experts have questioned the clinical validity underlying Interleukin's tests and hope Orig3n will not revive them.
The company has contracted with a urologist, who will review customers' requests for tests, and prescribe the firm's epigenetics-based male fertility analysis.