August 2009 Clinical Laboratory News: Regulatory Profiles

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August 2009: Volume 35, Number 8

CDC Tackles Genetic Testing Quality

For the first time, the federal government has issued recommendations for the accurate and proper use of genetic tests, published in the CDC’s June 12 issue of Morbidity and Mortality Weekly Report. The report is a product of a collaboration among the CDC, CMS, and CLIAC and is intended to guide labs on the total testing process for genetic tests. As such, the report provides “CLIAC recommendations for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions.”

Recommendations cover the preanalytic, analytic, and postanalytic phases, as well as the lab’s responsibilities concerning authorized persons, confidentiality of patient information, personnel competency, considerations before introducing molecular genetic testing or offering new molecular genetic tests, and the quality management system approach to molecular genetic testing.

The MMWR report is available online.

No Benefit in Gene Tests for DVT Risk, AHRQ Study Finds

A new report from AHRQ found insufficient evidence that genetic testing for two gene mutations in adults with a history of blood clots, Factor V Leiden (FVL) and prothrombin G20210A, helps prevent deep-vein thrombosis (DVT) or to improve other clinical outcomes. The report also found no benefit from testing family members of patients who have at least one mutation. While the authors of the evidence report were unable to find any studies that directly looked at genetic testing and patient outcomes, they did find that, for those with a history of clots, both patients with and without the genetic tendency to clot benefit similarly from blood-thinning drugs. The report calls for randomized trials to determine whether changing providers’ practices based on genetic testing improves outcomes.

The AHRQ evidence report is available online.

Comparative Effectiveness Priorities Point to Pharmacogenomics

The $1.1 billion set aside for comparative effectiveness research (CER) under the economic stimulus package should focus on complementing personalized medicine, according to a report from the Federal Coordinating Council for Comparative Effectiveness Research, a group set up to make recommendations on how money from the stimulus bill should be spent. The American Recovery and Reinvestment Act (ARRA) provided $400 million to the Office of the Secretary of HHS, $400 million to NIH, and $300 million to AHRQ.

The council wrote that “comparative effectiveness should complement the trend in medicine to develop personalized medicine,” and that “one of the advantages of large comparative effectiveness studies is the power to investigate effects at the sub-group level that often cannot be determined in a randomized trial.” The council also emphasized that the primary investment for the initial funding should be for data infrastructure, including linking current data sources to help answer CER questions, development of distributed electronic data networks and patient registries, and partnerships with the private sector.

The report is available online.

Defendants Can Question Lab Analysts at Trial

The U.S. Supreme Court has ruled that criminal defendants have the right to confront and question at trial those who prepare forensic reports. This includes scientists working in labs who have, until now, only been required to sign documents stating, for instance, that contraband in a case is an illegal drug. Decided by a narrow majority, the decision was written by Justice Antonin Scalia, who explained that “there is no support for the proposition that witnesses who testify regarding facts other than those observed at the crime scene are exempt from confrontation. The absence of interrogation is irrelevant; a witness who volunteers his testimony is no less a witness for Sixth Amendment purposes.”

The court’s decision is available online.

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