Friday, July 07, 2023
Quanterix Corporation has recently launched the LucentAD biomarker blood test to aid in the diagnosis of Alzheimer's disease (AD) in patients experiencing cognitive symptoms. LucentAD is designed to assist healthcare providers in evaluating individuals who may have early signs of AD by assessing the likelihood of amyloid pathology associated with the disease.
The LucentAD test, available alongside other diagnostic tools, offers a simplified process for clinicians to quickly determine if a patient has amyloid pathology consistent with AD. This information is valuable in determining appropriate follow-up and treatment plans for suspected Alzheimer's patients.
The test is conducted in Quanterix's CLIA laboratory, which is involved in various AD-related clinical trials. It measures an isoform of phosphorylated tau protein, specifically p-Tau 181, in plasma. Elevated levels of p-Tau 181 have been correlated with amyloid pathology, a characteristic feature of AD. The LucentAD test utilizes the Simoa p-Tau 181 assay, which has shown high specificity for AD-associated amyloid pathology in comparison to amyloid positron emission tomography (PET), a gold standard for AD diagnosis.
Quanterix has launched Lucent Diagnostics, a healthcare provider-facing portal, to meet the needs of patients and align with the increasing availability of AD therapies. By expanding access to the p-Tau 181 test, Quanterix aims to contribute to the development of a global infrastructure for Alzheimer's disease testing.
This announcement coincides with the FDA's recent approval of Leqembi, the first disease-modifying drug for Alzheimer's to receive full approval. The labeling for Leqembi's accelerated approval included the use of biomarkers, such as plasma p-Tau 181 measured through Quanterix's Simoa platform, to track therapy response. Quanterix emphasizes the urgent need for non-invasive blood tests to efficiently identify patients who can benefit from these treatments, especially during this critical time in the fight against Alzheimer's disease. Lucent Diagnostics plans to introduce additional tests aimed at improving the diagnosis and management of Alzheimer's and other neurological disorders. Healthcare providers can order the LucentAD test to enhance the diagnosis and care of individuals suspected of having Alzheimer's disease.
Source: businesswire.com
