February 2009 Clinical Laboratory News: News from the FDA

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February 2009: Volume 35, Number 2

  Genentech Urges Full FDA Regulation of LTDs

Genentech recently filed a Citizen Petition with the FDA imploring the agency to regulate all laboratory-developed tests (LDT). All IVD tests, whether marketed by manufacturers for other labs or developed in-house, should be held to the same regulatory and scientific standards to protect public health and ensure regulatory consistency, the petition advises. Genentech’s petition especially focuses on LDTs that make claims intended to guide specific therapies that the company says lack sufficiently validated claims. “The failure to apply clear and consistent standards and regulatory oversight to all laboratory-developed tests could threaten the public health and serve as a disincentive for the development of diagnostic test kits through FDA’s review pathway, thereby potentially undermining the move toward more personalized approaches to healthcare treatment and delivery,” the petition warns.

Genentech praised FDA’s IVDMIA guidance that lays out the agency’s intent to regulate tests that use proprietary algorithms to score multi-analyte tests. FDA has 180 days to respond to the petition, either approving it, denying it, or with an explanation of why the agency is unable to reach a decision.

FDA Education Program Wins Award 

The FDA’s monthly video series, “FDA Patient Safety News,” has been awarded the Cheers Award from the Institute for Safe Medical Practices for its efforts to improve the safe use of medical products and prevent medical errors. The Cheers Award honors organizations that have demonstrated a superior standard of excellence in the prevention of medication errors and adverse drug events. Although primarily intended for a professional audience, some of the videos in “FDA Patient Safety News” include information relevant to patients and consumers. The videos are available online

FDA Clears Anemia Test and Diagnostic Index

The FDA has cleared Beckman Coulter’s Access Soluble Transferrin Receptor (sTfR) Assay and sTfR/log ferritin index (sTfR Index) for use in diagnosing anemia. The assay is particularly useful in distinguishing between anemia caused by iron deficiency and anemia that results from chronic disease and inflammation altering ferritin, transferrin, and iron levels in a patient. The automated assay produces a recommended cutoff that can be used by a physician to understand the nature of a patient’s anemia, thereby helping determine the best course of treatment.

ActiveHealth Management to Push FDA Safety Alerts 

ActiveHealth Management, a provider of health management services, including disease management, clinical decision support, and personal health records, will now distribute safety alerts from the FDA through its personal health records software. Although users of the software currently receive updates about FDA recalls, gaps in care, potential medical errors, and opportunities to improve healthcare, this will be the first time FDA safety alerts about potential warning signs will be disseminated through the software. FDA recently has been taking a more active role in trying to reach consumers through software applications. The agency also teamed up with WebMD to broadcast consumer safety information to all registered users and website visitors.

FDA Approves Nucleic Acid Test for HIV 

The FDA has approved the cobas TaqScreen MPX Test, the first nucleic acid test that screens for the presence of two divergent types of HIV in donated blood plasma and tissue. The new test, manufactured by Roche Molecular Systems, Inc., detects nucleic acids from HIV-2 and HIV-1 Group O, which are predominantly found in Africa, as well as nucleic acids from HIV, HIV-1 Group M, and hepatitis B and C viruses. Rather than being used as a diagnostic tool, the test is designed to increase the safety of blood supplies by identifying infections earlier than traditional testing methods.

FDA Blocks Biopure Trial 

FDA has decided to block the U.S. Naval Medical Research Center from launching clinical trials of Biopure’s Hemopure, a novel blood substitute designed to be used when traditional blood transfusions are unavailable. The agency put the clinical hold on the trial for several reasons, citing concerns that patient bleeding could be exacerbated during trials and high mortality rates in previous trials with other blood products. FDA regulators also raised concerns about the information brochure prepared for researchers who would conduct the trial.

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