Google-backed genetic testing firm stops manufacturing at-home DNA test kit
London – A Google-backed genetic testing firm, 23andMe has reportedly stopped marketing its at-home DNA testing kit following warnings from the Food and Drug Administration (FDA).
The DNA test kit had been priced at 99 dollars and the firm has halted television, radio and online advertising for the analysis product after the FDA filed a warning letter last month.
According to the BBC, the FDA ordered the firm to ‘immediately discontinue’ its Saliva Collection Kit and Personal Genome Service (PGS) because it had failed to provide adequate information to support the claims made in the company’s marketing.
The spit test is supposed to provide details about a person’s health risks based on gene variants they carry.
23andMe’s co-founder Anne Wojcicki responding to the FDA letter said that the company has worked extensively with their lab partner to make sure that the results returned are accurate.
However, Wojcicki acknowledged that the FDA needed to be convinced of the quality of the data as well.
The report said that the FDA was particularly concerned about the potential health consequences of false positive or false negative assessments by the PGS for genetic risk related to breast cancer and to adverse drug responses.