Quanterix launches prescription blood test for Alzheimer's disease

The diagnostics company Quanterix hopes to gain new ground following the FDA’s recent full approval of Eisai and Biogen’s Leqembi treatment for Alzheimer’s disease, with the launch of an ultrasensitive blood test and a refreshed storefront for healthcare providers.

Dubbed Lucent Diagnostics, the company’s outlet will house LucentAD—a test that aims to help clinicians examine patients showing the early cognitive symptoms of the neurodegenerative disease.

LucentAD searches the blood for small traces of the protein p-Tau 181, which can be found in plasma and cerebrospinal fluid, and has been linked to the presence of amyloid plaque build-ups within the brain—allowing for an easier peek into what’s happening inside the body without relying exclusively on a PET scan or a more invasive procedure. 

The prescription blood test was built on Quanterix’s Simoa p-Tau 181 assay, which was previously used to help track responses to therapy among participants in Leqembi’s clinical trial, alongside other biomarkers.

Formerly known as lecanemab, Eisai and Biogen’s Allzheimer’s drug received an accelerated approval from the FDA about six months ago, based on reductions of amyloid beta plaques, before receiving a full regulatory green light last week after showing clinical benefits in a dementia rating scale following 18 months of treatment.

In Quanterix’s announcement, CEO Masoud Toloue said the launch of Lucent Diagnostics marks an important step toward its goal of ultimately making its test available worldwide.

“The FDA’s approval of Leqembi is an exciting day for families of the 55 million Alzheimer’s patients globally,” Toloue said. “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,” he added.

The LucentAD test has not been cleared by the FDA and will be available as a lab-developed test through Quanterix’s CLIA-certified laboratory.

Quanterix has separately aimed to develop its Simoa platform toward a different type of Tau protein, in a collaboration announced last year with Eli Lilly employing the Big Pharma’s biomarker known as p-Tau 217. Prior research showed that p-Tau 217 measurements in the blood could help differentiate Alzheimer’s disease from other neurodegenerative conditions.

The two companies also applied the test in clinical tests of Lilly’s donanemab—one of 2023’s most anticipated potential upcoming drugs—which earlier this year demonstrated it could help slow cognitive decline in Alzheimer’s patients by 35%, and lower the risk of advancing to later stages of the disease by 39%.

Meanwhile, other companies developing blood-based Alzheimer's tests are also looking to make moves following Leqembi's full approval. C2N Diagnostics said it plans to launch its upcoming PrecivityAD2 test later this summer for patients ages 55 and older with signs of mild cognitive impairment or dementia.