American Association for Clinical Chemistry
Better health through laboratory medicine
June 2009 Clinical Laboratory News: News From the FDA

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June 2009: Volume 35, Number 6

FDA Clears Rapid Test for Avian Flu

The FDA recently cleared a new, more rapid test for the detection of influenza A/H5N1, a subtype of the avian influenza A virus that can infect humans. The AVantage A/H5N1 Flu Test, manufactured by Arbor Vita Corporation, detects a specific protein, NS1, in throat or nasal swabs in < 40 minutes. According to CDC, of the avian influenza viruses that infect humans, the H5N1 subtype causes the largest number of serious disease and death in indentified cases. In clinical studies, the test correctly identified the absence of infection in more than 700 specimens and correctly detected the presence of influenza A/H5N1 in 24 cultured specimens from infected patients.

Phadia Announces Allergy Test Clearance

Phadia received clearance from FDA to for its new ImmunoCAP Rapid test, a disposable POCT that uses a small sample of blood to diagnose allergic diseases, such as asthma and rhinitis, in roughly 20 minutes. The device provides a first look at the IgE profile for patients based on the 10 most common inhaled allergens in the U.S. The European version of ImmunoCAP Rapid has been available in select countries for about 2 years. Phadia plans to market the single-use device to medical facilities by the end of the year.

C. difficile Assay Cleared

 Prodesse announced that it has received 510(k) clearance to market its ProGastro Cd Assay. The assay detects toxigenic strains of Clostridium difficile, a healthcare-associated infection that affects more than 500,000 patients in the U.S. annually. Prodesse said that in clinical studies its molecular assay detected 43% more positives than the current gold standard for testing, the cell cytotoxin assay. The ProGastro Cd Assay uses real-time PCR technology to produce results in as little as 3 hours. The ProGastro Cd Assay follows Becton Dickinson’s molecular diagnostic assay for C. difficile that received FDA clearance earlier this year.

News Update
UW-Madison Ends Medical Technologist Training Program

Despite the growing shortage of medical technologists, the University of Wisconsin-Madison School of Medicine and Public Health has announced that it will end its clinical laboratory science training program, citing cuts required by Wisconsin Governor Jim Doyle’s proposed budget. The program, which opened its doors in 1925, currently has about 80 students who will be allowed to finish their 4-year undergraduate studies, but the school will no longer enroll new students, according to Robert Golden, MD, the medical school dean.

Governor Doyle’s office told the medical school to cut its budget by 10% in order to help close a state budget gap of about $5 billion. The decision by the medical school to end the program will trim approximately $560,000 a year from the medical school’s budget of about $502 million. According to the school, the lab technologist program was selected because other schools in the University of Wisconsin system offer the same four-year program.

Sharon Ehrmeyer, PhD, MT(ASCP), CLS/MT program director and professor of pathology and laboratory medicine at UW-Madison, sent a letter to current students in the program expressing her concern. “Closure is not in the best interest of Wisconsin citizens’ healthcare needs,” Dr. Ehrmeyer stated in her letter. “Closing the CLS/MT Program will eliminate any possibility of filling available, high-paying, critically-needed, healthcare jobs every year and will jeopardize the quality of patient care.”