New test can detect patients' risk of harmful side effects from Alzheimer's drugs
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CHICAGO, July 31, 2024 ~ At the ADLM 2024 conference, formerly known as the AACC Annual Scientific Meeting & Clinical Lab Expo, researchers from Revvity's Euroimmun will be presenting data on a new test that could potentially improve outcomes for patients with Alzheimer's disease. This test predicts whether patients are genetically predisposed to side effects from anti-amyloid drugs, a promising new class of Alzheimer's therapeutics.

The use of anti-amyloid drugs has been a major breakthrough in the treatment of Alzheimer's disease. Last year, lecanemab became the first medication ever to receive FDA approval for slowing the progression of the disease. Since then, more anti-amyloid drugs have also received FDA approval, offering hope to individuals with this condition. However, concerns have been raised about the safety of these drugs, with the FDA warning that they can cause brain swelling and/or bleeding. This side effect is known as amyloid-related imaging abnormalities (ARIA), and while it is usually mild, it can lead to death in rare cases. The risk of ARIA is higher in individuals who have specific variants of the APOE gene, which is implicated in many forms of Alzheimer's. As a result, the FDA recommends that patients undergo genetic testing before taking anti-amyloid drugs.

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The team at Revvity's Euroimmun has developed a new PCR-based test that can determine if a patient has a high-risk combination of APOE gene variants (also known as a genotype). This method tests for all six possible APOE genotypes simultaneously, allowing for quicker processing by laboratories and ensuring that patients receive results faster. To evaluate its performance, the researchers used this test to analyze 100 blood samples from Alzheimer's patients and 10 samples from healthy blood donors. They also analyzed the same samples using a CE-IVD-marked APOE test and bidirectional Sanger sequencing method and compared the results from all three methods. The results were consistent in all 110 cases, demonstrating that the Revvity's Euroimmun test accurately detects a patient's APOE genotype with 100% accuracy.

Dr. Maite Sabalza, senior scientific affairs manager at Revvity's Euroimmun, explained the importance of this new test in light of the recent advancements in anti-amyloid drugs. "There has been a lot of progress with new drugs approved by the FDA, and as a result, diagnostic assays need to be updated to be able to test for the consequences of these drugs," she said. "There is a need to screen patients before receiving treatment, and if they are positive for a high-risk APOE genotype, doctors can discuss the possibility of stopping or monitoring the treatment or trying something different."

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The team at Revvity's Euroimmun is hopeful that their test will become an essential part of the care Alzheimer's patients receive before starting anti-amyloid therapy. "We want to help these patients," Dr. Sabalza stated.

The presentation of this research will take place during the scientific poster session on Wednesday, July 31st from 9:30 a.m. to 5 p.m., with presenting authors available for questions from 1:30 p.m. to 2:30 p.m. The session will be held in the Poster Hall on the Expo show floor at McCormick Place in Chicago.

For media members interested in attending ADLM 2024, registration is free and can be completed online at https://xpressreg.net/register/adlm0824/media/l.... This conference offers valuable insights into cutting-edge research and advancements in laboratory medicine and diagnostics.
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