In 2017, Quest Diagnostics, based in Secaucus, New Jersey, developed a liquid chromatography tandem mass spec test for evaluating the Aβ42/40 ratio in CSF ( Weber et al., 2019). Blood tests would be simpler, more widely available, and more appealing to patients.Įnter Quest AD-Detect. Also, the test is not an option for some people, for example anyone on blood thinners. While physicians in Europe routinely sample CSF, doctors in the U.S. Nonetheless, CSF testing has drawbacks, requiring an invasive lumbar puncture that can cause side effects, such as headache. soon,” Sasha Bozeat at Roche told Alzforum. “The Elecsys AD CSF assays are available now in CE-marked countries, and we hope to bring them to the U.S. Other CSF assays may soon be on the market. “Any physician, primary care provider, or specialist can use this test to improve the accuracy of their diagnosis,” he wrote to Alzforum (full comment below).Īnother plus to FDA approval: It is expected to streamline the process for future fluid biomarkers, because they can be compared to an existing standard. It discriminates amyloid-positive from -negative people with an accuracy of around 90 percent, and closely agrees with amyloid PET ( Dec 2017 conference news Nov 2018 conference news).Īndrew Budson at Boston University said this first FDA approval represents an enormous step forward. The test, an immunoassay run on the fully automated Lumipulse platform, is intended for use in people 55 or older with cognitive impairment. “In the U.S., the FDA process is the only way to be confident you are using an assay that had all of its clinical claims vetted by an independent group of unbiased scientists,” Rianne Esquivel at Fujirebio told Alzforum.įujirebio’s CSF Aβ test was approved through the FDA’s De Novo pre-market review pathway, which is used for devices or assays with little risk to the patient. This is because the FDA evaluates the effectiveness of an assay in the clinical population that will use it, while certification, which only attests to the quality of the test, does not. In addition, the agency’s approval carries weight in Europe and elsewhere around the world, Zetterberg said. Researchers expect FDA approval to boost confidence in the tests, smoothing the path to widespread clinical usage and reimbursement. “CSF tests for AD have been in that gray zone,” Suzanne Schindler at Washington University in St. So why is FDA approval even necessary? Private insurers have occasionally balked at paying, calling the CLIA-approved assays experimental. These CLIA-certified tests are typically reimbursed. Many CSF tests are certified by the federal Clinical Laboratory Improvement Amendments (CLIA) for diagnostic testing, and thus can be used clinically. In the United States, their use has been more scattershot and mostly in research settings or specialty clinics. “It’s very important that we understand how best to interpret these markers for clinical practice,” Mielke said.įDA Approval Could Open Floodgates for Clinical CSF TestingĬSF AD tests have been part of clinical practice in Europe for more than 20 years, and are now used routinely. Researchers also noted the need for more data on how the tests perform in diverse populations and in people with comorbidities, which are more common in routine clinical care than in research studies. Importantly, all these fluid biomarker tests are intended for use in people with cognitive impairment, not for detecting preclinical disease in cognitively healthy people. Nonetheless, researchers cautioned that primary-care physicians will need training to properly interpret Aβ biomarker test results, which can aid diagnosis but by themselves do not indicate the presence of disease. Meanwhile, Michelle Mielke at Wake Forest University in Winston-Salem, North Carolina, noted that blood-based biomarkers will facilitate more widespread AD screening, particularly in rural areas where PET imaging or CSF testing may not be available. The rigorous FDA evaluation gives it a quality stamp,” Henrik Zetterberg at the University of Gothenburg, Sweden, told Alzforum. “The approval of a CSF test is an important first step for fluid biomarkers. Quest AD-Detect will join C2N Diagnostics’ Precivity AD assay as the only blood tests certified for clinical use in the United States, though these tests are not yet FDA-approved or covered by insurance. Primary care physicians want training on how to use these tests in clinical practice.Īdding another option for fluid marker testing, Quest Diagnostics, the largest diagnostic company in the world, announced May 2 that it plans to market a plasma Aβ assay in the United States.Quest Diagnostics will offer a plasma Aβ assay nationwide.The FDA approved the first CSF AD test, Fujirebio’s Aβ42/40 assay.
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