Diagnostic test maker Quanterix has launched LucentAD, a biomarker-based prescription Alzheimer’s disease (AD) test to help in the diagnosis of the disease.
The test is intended to help diagnose Alzheimer’s disease with other diagnostic tools. It is not intended as a standalone screening or diagnostic assay, according to Quanterix.
LucentAD is designed to evaluate patients experiencing cognitive symptoms that indicate early signs of Alzheimer’s disease.
It measures the phosphorylated form of the tau 181 protein isoform, a biomarker for Alzheimer’s disease pathology. Its concentration in plasma and cerebrospinal fluid has been shown to be positively correlated with amyloid plaques in the brain, a hallmark of the disease. As such, the test could be used as a surrogate for amyloid buildup without needing a PET scan or other invasive procedures.
The protein is found at low levels in the blood, necessitating high analytical sensitivity to measure it reliably.
LucentAD will provide clinicians with a simplified process to quickly evaluate the likelihood of a patient with amyloid pathology being consistent with Alzheimer’s, according to Quanterix’s press release announcing the launch of the test.
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While the test has not received clearance from the US Food and Drug Administration (FDA), it was developed and validated in a manner consistent with Clinical Laboratory Improvement Amendments (CLIA) requirements, said Quanterix. It will be available as a lab-developed test through Quanterix’s CLIA-certified laboratory.
The launch of the LucentAD test closely follows the FDA approval of Eisai and Biogen’s Leqembi for the treatment of Alzheimer’s disease.
LucentAD was developed using Quanterix’s Simoa p-Tau 181 assay, which, along with other biomarkers, was used to help track responses to therapy in Leqembi’s clinical 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, in the company’s news release. “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.”
Lucent Diagnostics is Quanterix’s new healthcare provider-facing portal. It was launched to support patients when a therapy for the disease has become more widely available.
Quanterix said 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 by prescription from a healthcare provider.
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