Quanterix Launches LucentAD Biomarker Blood Test to Aid Physician Diagnosis of Alzheimer’s Disease in Patients
Test will play an important role in the evaluation of patients experiencing cognitive symptoms consistent with early signs of Alzheimer’s disease
The LucentAD test is run by Quanterix’s CLIA laboratory, which powers many of the clinical trials associated with AD.
“A year ago,
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
“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
To learn more about
For more information about Quanterix’s work in neurology, visit: https://www.quanterix.com/therapeutic-areas/neurology/.
The LucentAD test was developed and validated by
The Lucent test measures tau protein phosphorylated at threonine 181. Circulating levels of p-Tau 181 have been shown to be a marker of Alzheimer’s Disease (AD) pathology. The test results are intended as an aid in the diagnostic evaluation of AD, to be used in adults presenting with cognitive impairment who are being evaluated for AD. LucentAD test results must be interpreted in conjunction with other diagnostic tools. This test is not intended as a standalone screening or diagnostic assay.
From discovery to diagnostics, Quanterix’s ultrasensitive biomarker detection is fueling breakthroughs only made possible through its unparalleled sensitivity and flexibility. The Company’s Simoa® technology has delivered the gold standard for earlier biomarker detection in blood, serum or plasma, with the ability to quantify proteins that are far lower than the Limit of Quantification (LoQ) of conventional analog methods. Its industry-leading precision instruments, digital immunoassay technology and CLIA-certified Accelerator laboratory have supported research that advances disease understanding and management in neurology, oncology, immunology, cardiology and infectious disease.
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