Early in June, exactly 96 customers of 23andMe, Inc., were notified that they had received the wrong genetic test results. It was particularly bad timing, since the company had just been sent a letter from the FDA asserting its authority to regulate genetic testing. Bloggers reported that, on its web site and accessible only to customers with a PIN, 23andMe explained that its contract testing laboratory had committed human error. A single 96-well plate with samples had been incorrectly placed. Bloggers also reported that the mistake happened at Laboratory Corporation of America, which does genetic testing on contract for 23andMe.
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Among some of the 96 individuals who got the wrong genetic test results, there was considerable consternation. In fact, it was the customers who discovered the mistakes and brought them to the attention of officials at 23andMe. One mother who posted on the web described her distress that the results, as reported by 23andMe, showed her daughter as a match for the family, but that her son was not a match for either herself or her husband. Critics pointed out that, prior to this problem, 23andMe appeared not to have put even basic error-checking procedures in place. These events are a reminder to the clinical laboratory testing profession that the media is increasingly swift to pick up and report errors associated with laboratory testing.
RED CROSS FINED $16 MILLION BY FDA FOR BLOOD ISSUES
Last week, the Food and Drug Administration levied a $16 million fine on the American Red Cross. Most of the issues focused on violations in the screening of donated blood for the years 2008 and 2009. A fine of $10 million was assessed for mismanagement of blood products, including red blood cells, plasma, and platelets. The balance of the fine—$6 million—was for faulty manufacturing processes. About 43% of the blood supply in the United States is supplied by the American Red Cross.
GEN-PROBE INVESTS $50 MIL IN PACBIO
Gen-Probe, Inc., made a $50 million strategic investment in Pacific Biosciences, Inc., of Menlo Park, California. Pacific Biosciences is developing technology to perform whole human genome sequencing. The two companies will collaborate to develop new clinical diagnostic systems. This transaction shows how established molecular IVD companies are exploring ways to use rapid gene sequencing technologies.
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