American Association for Clinical Chemistry
Improving healthcare through laboratory medicine
November 2011 Clinical Laboratory News: News from the FDA

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Test to Evaluate Likelihood of Ovarian Cancer Cleared

Fujirebio Diagnostics has received FDA clearance to market its HE4 Test in an algorithm called ROMA, which involves the company’s HE4 EIA and Abbott’s ARCHITECT CA 125 II test. The algorithm is designed to determine whether a pre-or postmenopausal woman who presents with an ovarian adnexal mass is at high or low likelihood of finding malignancy on surgery. Researchers have shown that HE4 is elevated in epithelial ovarian cancers (EOC), the most common type of ovarian cancer. The newly cleared test combines physician assessment with the independently validated ROMA algorithm to help identify those patients at high likelihood of malignancy who should have their surgery performed by a gynecologic oncologist.

Prognostic Test for Prostate Cancer Gets Green Light

Iris International has received FDA clearance to market its Nadia ProsVue prognostic cancer test for prostate cancer. The test combines immunoassay with real-time PCR methodologies to determine the rate of change of total prostate-specific antigen in serum over time. According to the company, the test is not intended for the diagnosis or monitoring of prostate cancer.

EraGen’s Kit Cleared for HSV-1 and HSV-2 Detection

EraGen Biosciences, a Luminex Company, has received FDA clearance to use the NucliSENS easyMAG extraction system with the MultiCode -RTx HSV 1&2 Kit. With this clearance, labs can now use either Roche’s MagNa Pure system or the easyMag extraction system with the kit. The MultiCode-RTx HSV 1&2 Test provides PCR-based qualitative testing and is designed to detect HSV-1 or HSV-2 in vaginal lesion swab specimens from symptomatic female patients to help diagnosis genital herpes.

Test to Diagnose Cryptococcal Meningitis Cleared

FDA has cleared a new diagnostic test to help AIDS patients suffering from cryptococcosis, a fungal meningitis. The CrAg Lateral Flow Assay works by detecting the cryptoccocal antigen. The test was developed through a collaboration between Tom Kozel, professor of microbiology of the University of Nevada School of Medicine, and Sean Bauman, president and CEO of IMMY (Immuno-Mycologics) of Oklahoma.

Influenza A/B Tests Get Nod

FDA has cleared two molecular diagnostic flu tests for use on Idaho Technology’s Joint Biological Agent Identification and Diagnostics System. The Influenza A/B detection kit identifies influenza A and B. Both kits detect viral nucleic acids isolated and purified from nasopharyngeal swabs and washes from patients with respiratory infection symptoms.