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AMP bolsters position on consumer genomic testing

July 2019—The Association for Molecular Pathology revised its position for all consumer genomic testing. Based on a recent assessment of the current market landscape and privacy best practices, the latest position statement features an expanded list of conditions that must be met before the AMP can support a clinically meaningful test. The AMP remains neutral to all recreational, novelty, and ancestry testing that may create educational opportunities for the public.

The expanded set of conditions is as follows:

• All health-related claims must have well-established clinical validity.
• The consumer genomic testing provider must comply with the CLIA statute and regulations. Test validation and interpretation should be performed by board-certified molecular laboratory professionals.
• Information regarding the analytical and clinical validity of the tests should be present in all marketing materials and included in each report of results.
• The consumer genomic test report should be in lay language and describe the limitations of the test, an interpretation of the finding(s), and significance for the consumer’s health status, as well as implications for family members.
• Test providers should adhere to the Future of Privacy Forum’s “Privacy Best Practices for Consumer Genetic Testing Services.”
• Consumer genomic testing providers should refer consumers to appropriate genetic counselors and recommend that they discuss actionable test results with their physicians.

In 2007, the AMP issued a direct-to-consumer testing statement that concluded that health-care–related genetic testing should be available only through appropriately qualified health professionals who order tests from CLIA-certified laboratories. That statement was revised in 2015 to support clinically meaningful direct access genetic testing, as long as certain conditions are met. The 2019 statement, issued in June, contains updates and expansions to the conditions that must be met before the AMP can support such testing.

The full position statement is at www.amp.org/2019GenomicTestStatement.

FDA clears tests for chlamydia and gonorrhea from extragenital specimens

The Food and Drug Administration cleared for marketing two tests that can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae through diagnostic testing of extragenital specimens.

The Aptima Combo 2 Assay and the Xpert CT/NG are the first devices cleared for extragenital diagnostic testing of these infections via the throat and rectum. These tests were previously cleared only for testing urine, vaginal, and endocervical samples.

In its evaluation of the devices, the FDA reviewed clinical data collected through a cross-sectional study coordinated by the Antibacterial Resistance Leadership Group, which is funded and supported by the National Institute of Allergy and Infectious Diseases. The study was collaborative and multisite and consisted of more than 2,500 patients.

The FDA granted clearance of the Aptima Combo 2 Assay to Hologic. It granted clearance of the Xpert CT/NG to Cepheid.

In other Hologic news, the FDA granted clearance for the company’s Aptima bacterial vaginosis and Aptima Candida vaginitis and Trichomonas vaginalis assays.

Qiagen launches FDA-approved CDx for PIK3CA biomarkers

Qiagen launched its Therascreen PIK3CA RGQ PCR Kit after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with Piqray (alpelisib), a newly approved Novartis therapy.

The Therascreen PIK3CA Kit is the first companion diagnostic assay to obtain premarket approval from the Food and Drug Administration for use in any cancer indication for detection of activating mutations in the PIK3CA gene. It is also the first FDA-approved assay for guiding treatment decisions in breast cancer using plasma specimens as a liquid biopsy. The assay detects 11 PIK3CA mutations.