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Ancestry, 23andMe, DiaSorin, Adaptive Biotechnologies, Others Receive FDA Clearances in August

NEW YORK ─ As the coronavirus pandemic continued to attract the attention of the US Food and Drug Administration in August, the agency for the second consecutive month granted only a few 510(k) clearances for in vitro diagnostic products.

The FDA granted clearance to consumer genetic testing company for over-the-counter use of its AncestryDNA Factor V Leiden Genetic Health Risk Test for hereditary thrombophilia. The qualitative genotyping test detects clinically relevant DNA variants isolated from human saliva. Specifically, its health risk report has been cleared for reporting of the Factor V Leiden variant in the F5 gene. The report describes whether a person has variants associated with a higher risk of developing harmful blood clots but does not describe a person's overall risk of developing harmful blood clots, according to the FDA. Additionally, the test is most relevant for people of European descent.

Samples are collected from people 18 years and older using the AncestryDNA Saliva Collection Kit. Lehi, Utah-based Ancestry separately received the green light for its saliva collection kit.

A second consumer genetics company, Sunnyvale, California-based 23andMe, got the green light in August for its CYP2C19 Drug Metabolism Report, which informs customers about whether their genotypes may influence their ability to respond to clopidogrel and citalopram without the need for confirmatory testing.

There were clearances, as well, for two pregnancy test companies. San Diego-based Acon Laboratories got the go-ahead for its Distinct Early Detection Pregnancy Test, a chromatographic immunoassay for self-testing and at-home use that detects human chorionic gonadotropin in urine and provides results in three minutes. The immunoassay's test strip uses monoclonal anti-hCG antibodies and goat anti-mouse polyclonal antibodies to detect hCG.  

Meantime, Hangzhou, China-based Safecare Biotech received clearance for its hCG Urine Test Strip, hCG Urine Test Cassette, and hCG Urine Test Midstream early pregnancy testing products.

HemoCue, based in Angelholm, Sweden received clearance for its HemoCue Hb 301 System to measure hemoglobin concentration in a primary care setting for infants more than 1 month old, children, adolescents, and adults. The system was also cleared to measure hemoglobin concentration in blood donation settings for adults.

Santa Clara, California-based Lin-Zhi International got the nod for its LZI Fentanyl II Enzyme Immunoassay to detect norfentanyl in human urine at the cutoff value of 5 ng/mL. The assay ─ which provides only a preliminary analytic result ─ is designed for prescription use with a variety of automated clinical chemistry analyzers.

Additionally, Instrumentation Laboratory, based in Bedford, Massachusetts got the nod for an automated immunoassay to detect von Willebrand Factor antigen in human citrated plasma on the firm's coagulation analyzers.

In other regulatory news in August, Seattle-based Adaptive Biotechnologies received an expanded clearance for its clonoSeq assay to assess minimal residual disease in patients with chronic lymphocytic leukemia, and Cypress, California-based DiaSorin Molecular received clearance in for its Simplexa Flu A/B and RSV Direct Gen II kit. The company announced the clearance on Monday.