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Consumers have filed complaints about the San Diego-based firm's questionable business practices and lack of response in the last year.
While it continues to seek investments, the firm is also making preparations for an initial public offering on the Nasdaq First North exchange.
PWNHealth will enable Stratify to offer its Prompt Personal Genetic Score prostate cancer genetic risk test directly to consumers with medical oversight.
During a conference call to discuss the firm's second-quarter results, CEO and President Francis deSouza also highlighted potential growth from clinical sequencing.
The organization continues to support direct access genetic testing for healthcare decision making, while remaining neutral on recreational, novelty, lifestyle, and ancestry genetic testing.
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.