Originally Published IVD Technology
September 2003
INDUSTRY NEWS
Notable
FDA cleared the first test that will be used as an aid for clinical laboratory diagnosis of West Nile Virus (WNV) infection. The WNV IgM capture ELISA by
PanBio Ltd. (Windsor, Australia) reduces the time required to obtain test results. The current WNV test takes two days to process and up to two weeks before results are received. PanBio’s test takes only hours and results are available on the same day.
Although IgM antibodies can be detected within the first few days of onset of illness, detection of antibody is not always specific in patients with acute viral infections. Test results should be confirmed with an additional test.
In obtaining its FDA clearance, PanBio pursued a de novo 510(k) route. FDA will use this method of rapid review and approval in the future when significant and appropriate literature exists for a pathogen that is the likely cause of an emerging disease.
DiaDexus Inc. (San Francisco) received FDA marketing clearance for its PLAC test. The test may be used as an aid, along with clinical evaluation and other tools, for predicting risk for coronary heart disease (CHD), the leading killer of both men and women in the United States.
The test measures the level of an enzyme, lipoprotein-associated phospholipase A2 (Lp_PLA2), in blood. This enzyme has been identified as an independent risk factor for coronary events, and can thus alert physicians to elevated risk when few other indicators, including elevated LDL-cholesterol levels or C-reactive protein levels, are present.
Christine Ballantyne, MD, director of the Center for Cardiovascular Disease Prevention at
Baylor College of Medicine and the Methodist DeBakey Heart Center (Houston) notes, “Somewhere between one-third and one-half of heart attacks occur in people considered to have normal LDL cholesterol. This test enables us to better determine who is at risk for CHD before an event occurs, allowing both the individual and his or her physician to take proactive and preventative measures.”
Quest Diagnostics (Teterboro, NJ) has entered into a partnership with Stop and Shop Supermarket Co. (Quincy, MA) to market diagnostic testing services directly to the public. The northeastern U.S. supermarket chain will sell Quest’s lab service cards at 60 of its in-store pharmacies in Connecticut.
Quest’s lab services will allow consumers to bypass physician input entirely. Consumers will register their cards by telephone or through the Internet, and then provide a specimen at one of Quest’s 71 patient service centers in Connecticut. The testing will be performed in Quest’s regional laboratory, and results will be received by mail or over the Internet.
QuesTest services include a menu of 24 individual diagnostics and multitest panels including general wellness, chronic disease risk, infectious diseases, allergies, pregnancy, and drugs of abuse testing. Consumers receive materials encouraging them to obtain help from a physician in interpreting test results.
The Medicines and Healthcare Products Regulatory Agency (MHRA; London) sent a letter to the chief executives of Strategic Health Authorities and chief executives of Acute NHS Trusts within the Department of Health (UK) clarifying the role of the IVD Directive in regulating home-brew tests. The letter stated that only those tests that are manufactured and used in the healthcare institution “or on near by premises” in which patients are providing samples are exempt from the requirements of the IVD Directive.
Tests for which samples are provided from within the same institution, but on a different premises; for which samples have been provided by a legal entity that is separate from the manufacturer; or for which the manufacturing institution transfers the test for use to another legal entity will all be subject to regulation under the IVD Directive.
In a brief letter to the manufacturer, FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD; Rockville, MD) called into question
Roche Diagnostics’ (Basel, Switzerland) conclusion that its AmpliChip CYP450 is properly marketed as an analyte specific reagent (ASR). Most ASRs are categorized as class I devices, and are therefore exempt from premarket review. However, most devices that do not fall under the class I classification are subject to FDA scrutiny.
In the letter, OIVD director Steven Gutman notes that, while the ASR rule classifies an ASR as a reagent used for the “identification or quantification of an individual substance or ligand,” Roche’s press release describes a “multi-signal device composed of probes for 33 different mutations.” Gutman further states that the product release indicates that the company intends the chip to be used with a “specific configuration of proprietary accessories [and] consequently, the AmpliChip microarray appears to be an assembled device that is part of a specific test system.” The OIVD director stressed the importance of properly classifying the AmpliChip-based test, noting “manufacturers of class II and class III medical devices [must] obtain FDA marketing clearance or approval . . . before they can offer [their products] for sale.”
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