Q&A: Blood-based biomarker testing ‘scientific consensus favorite’ for AD detection

Key takeaways:

• Quanterix’s blood-based immunoassay measures phosphorylated-tau 217, a biomarker of Alzheimer’s pathology.
• The company expects rapid access and global expansion for the assay over the next 18 months.

Earlier this year, the FDA granted breakthrough device designation to Quanterix for its blood-based diagnostic assay to aid in the diagnosis of Alzheimer’s disease.

LucentAD p-Tau 217 is a semi-quantitative in vitro diagnostic immunoassay intended to measure phosphorylated-tau 217, a biomarker that may be crucial in diagnosing Alzheimer’s disease in those who present to a clinical setting with cognitive impairment.

Healio spoke with Quanterix CEO Masoud Toloue to discuss the next steps in the process to make this new method of testing readily available.

Healio: What was the main driving force behind developing this type of blood-based biomarker test?

Toloue: FDA approved anti-amyloid treatments for Alzheimer’s disease are most beneficial to those patients diagnosed in earlier stages of the disease. These therapies have elevated the need for a non-invasive, widely accessible blood test to aid in the early diagnosis of AD, which prompted the development of LucentAD p-Tau 217. P-tau 217 has emerged as the scientific consensus favorite as being the most accurate, single blood-based biomarker for this purpose.

Our proprietary, ultrasensitive Simoa technology enables measurements of p-tau 217 at very low levels in plasma with a simple blood draw, making LucentAD p-Tau 217 a valuable tool to aid in the early diagnosis of AD.

Healio: What are the next steps for Quanterix with an FDA breakthrough designation in pocket?

Toloue: We were pleased that the FDA recognized the breakthrough nature of our p-Tau 217 assay and its potential to have a significantly positive impact on a more effective diagnosis of a life-threatening disease. Breakthrough device designation confers a priority status on the proposed product for expedited review by the regulatory body.

Healio: How soon do you expect your health network partnership to be able to expand access for the test?

Toloue: The test is commercially available to providers and networks within the United States.

We have dedicated sales, operations, and access teams actively working to streamline its implementation. While Lucent Diagnostics is in various stages of integration in a number of systems and networks within the U.S., we expect rapid access and global expansion over the next 18 months.

Healio: Briefly discuss your plans for a global Alzheimer’s testing infrastructure, andhow future FDA action on Simoa p-Tau 217 may influence those plans.

Toloue: In the U.S., Quanterix is actively engaged with the FDA to gain clearance for diagnostic tests for Alzheimer’s, including plasma p-tau 217.

Additionally, we are continuing to work with international regulatory authorities to provide best-in-class products, including engagement with partners to gain regulatory approval for products based on Simoa.