Quanterix Corporation (NASDAQ: QTRX), a company fueling scientific discovery and breakthrough diagnostics through ultrasensitive biomarker detection, today announced it has launched LucentAD, a test to assist in the evaluation of patients experiencing cognitive symptoms consistent with the early signs of Alzheimer’s disease (AD). The LucentAD test, which will be available to healthcare providers as an aid in conjunction with other diagnostic tools, provides clinicians with a simplified process to quickly assess the likelihood of a patient having amyloid pathology consistent with AD. This information will help healthcare providers determine appropriate follow up and treatment planning for a suspected Alzheimer’s patient.

The LucentAD test is run by Quanterix’s CLIA laboratory, which powers many of the clinical trials associated with AD. Lucent Diagnostics is Quanterix’s new healthcare provider-facing portal, launched to meet the needs of patients at the same time a therapy for the disease has become more widely available. The test measures an isoform of phosphorylated tau protein in plasma. This isoform is phosphorylated at the 181 residue of the protein (p-Tau 181), and its concentration in plasma and cerebrospinal fluid, has been positively correlated to the presence of amyloid pathology in the brain, a hallmark of Alzheimer’s disease. LucentAD utilizes the Simoa p-Tau 181 assay that has been extensively studied in large longitudinal and cross-sectional cohorts, and its high specificity for amyloid pathology for AD has been well established through comparison to amyloid positron emission tomography, a gold standard for AD diagnosis. p-Tau 181 is a low-abundance protein in blood, requiring high analytical sensitivity for its reliable measurement. While the clinical validity of Simoa plasma p-Tau 181 measurements have been well studied, the test has also recently been shown to correlate with reduction in amyloid load in the brains of amyloid patients on anti-amyloid drug therapy, as demonstrated in the lecanemab (Leqembi) Clarity AD drug trial.

“A year ago, Quanterix announced the validation of our laboratory developed test to quantitatively measure p-Tau 181 in plasma as an aid in diagnostic evaluation of Alzheimer’s disease,” said Masoud Toloue, CEO at Quanterix. “The launch of Lucent Diagnostics and availability of the LucentAD test expands access to our p-Tau 181 test for healthcare providers and marks an important step in our goal to help build a global Alzheimer’s disease testing infrastructure.”

The announcement of the LucentAD test comes at an exciting time for AD treatment and discovery, coupled with today’s historic announcement FDA approval of Leqembi, the first disease-modifying drug for Alzheimer’s to receive full approval. Earlier this year, Leqembi was granted accelerated approval by the FDA for the treatment of patients with early-stage AD, an important step forward in the fight against the disease, based on strong early clinical trial data. As detailed in the Leqembi labeling for accelerated approval, several biomarkers were used to track response to therapy, including plasma p-Tau 181, which was measured using Quanterix’s Simoa® platform.

“The FDA’s approval of Leqembi is an exciting day for families of the 55 million Alzheimer’s patients globally,” continued Toloue. “However, access to therapy will continue to be limited until the global infrastructure for patient testing is built. Non-invasive blood biomarker testing is the only way to democratize access to Alzheimer’s disease therapies and Quanterix will offer our testing solutions to healthcare providers who want to provide this important service to patients.”

“The clinicians working with dementia patients are viewing the coming of FDA-approved therapies for Alzheimer’s disease with a mixture of excitement and anxiety, as the diagnostic paths to qualify patients for treatment in clinical practice are still inefficient in most clinics,” said Tharick Pascoal, MD., Ph.D. Behavior Neurologist and Associate Professor of Psychiatry and Neurology at the University of Pittsburgh. “The availability of non-invasive blood tests to more efficiently identify patients for these treatments is an urgent need at a critical moment in the fight against this disease.”

Lucent Diagnostics will announce additional tests aimed at improving the diagnosis and management of Alzheimer's and other neurological disorders. The LucentAD test is available through a healthcare provider’s order.