March 21, 2011 “Intelligence: Late Breaking Lab News”

Regulation of genetic tests by the Food and Drug Administration (FDA) continues to move forward. Earlier this month, an FDA advisory panel conducted hearings on this subject. The Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee discussed several aspects of direct-to-consumer (DTC) genetic testing. Experts on the panel advocated that consumers should only access “clinical genetic tests” through their physicians.

ADD TO: Genetic Tests

More relevant for pathologists and clinical lab administrators were public statements made by FDA officials during this meeting that address the agency’s intent to regulate at least some genetic testing. “It’s not under question that [DTC genomics firms] will be regulated,” declared Alberto Gutierrez, Director of the Office of In Vitro Diagnostics in FDA’s Center for Devices and Radiological Health, during the meeting. “They will be.”


If there is one public laboratory company that has maintained a sustained rate of double-digit growth throughout the recession and the slow economic recovery, it is BioReference Laboratories, Inc. (BRLI), of Elmwood Park, New Jersey. On March 3, the company reported its first quarter 2011 earnings. The company increased its net revenues by 23%, from $99.3 million in Q1-10 to $121.7 million in Q1-11. Its patient count grew 20% during the same period, from 1.2 million to 1.5 million.


Earlier this month, at a meeting conducted in Addis Ababa, Ethiopia, the African Society for Laboratory Medicine (ASLM) was launched. Eight African countries sent officials from their respective ministries of health to the meeting. In a press release about the event distributed by the American Society of Clinical Pathology (ASCP), it was noted that “ASLM will serve as a professional body to guide laboratory network development and strengthen efforts in Africa; guide the process of certification of laboratory medicine training; and work… to develop and implement laboratory policies and guidelines in the African region.”

Dark Daily Update

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about…

…a single genetic test developed at the National Center for Genome Resources to screen prospective parents and that can accurately detect mutations associated with 488 different diseases.

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