Quanterix's LucentAD: Pioneering Alzheimer's Diagnostics with CMS Momentum

The Alzheimer's diagnostics space is on the cusp of a seismic shift, and Quanterix's LucentAD test is poised to lead the charge—if it can navigate the regulatory and reimbursement hurdles. With the Centers for Medicare & Medicaid Services (CMS) tightening its grip on coverage criteria for amyloid-beta testing, the stakes for Quanterix have never been higher. But for investors, the company's strategic moves and the evolving CMS landscape present a compelling case for long-term growth.

CMS's Role in Shaping the Market

CMS's Medical Policy LAB.00046, updated in July 2025, sets a clear framework for coverage of Alzheimer's biomarker testsQuanterix Corporation^[1]. The policy mandates that long-form amyloid-beta testing via cerebrospinal fluid (CSF) is covered only when three conditions are met: the test is part of amyloid-targeting therapy evaluation, uses specific metrics (e.g., ), and is not performed on asymptomatic individualsQuanterix Corporation^[1]. This creates a narrow window for reimbursement, effectively sidelining blood-based tests like Quanterix's LucentAD p-tau217 until CMS updates its stance.

However, the absence of a finalized National Coverage Determination (NCD) for LucentAD's blood test isn't a dead end—it's a catalyst. Quanterix's $300 LucentAD test, , is already being used in clinical settings, albeit without Medicare reimbursement. The company's aggressive push for high-triple-digit reimbursement ratesQuanterix Chases Growth While Losses Keep Investors On^[2] suggests confidence that CMS will eventually expand its criteria to include blood-based biomarkers, especially as data from four ongoing clinical trials (expected to complete enrollment by Q4 2025Quanterix Corporation^[1]) strengthens the test's clinical validity.

Strategic Scaling: Mergers and Market Expansion

Quanterix isn't waiting for CMS to catch up. The company's planned merger with Akoya Biosciences is a masterstroke, . This isn't just about scale—it's about positioning LucentAD as the gold standard in a fragmented diagnostics landscape. By integrating Akoya's proteomics expertise, Quanterix is building a moat around its multi-marker, algorithm-driven test, which combines p-tau217 with other biomarkers to deliver a more nuanced Alzheimer's risk profileQuanterix Chases Growth While Losses Keep Investors On^[2].

The financials back this up. , . This fiscal prudence is critical in a sector where regulatory delays can derail even the most promising technologies.

Risks and Rewards

The road isn't without potholes. CMS's current stance on asymptomatic testingQuanterix Corporation^[1] could limit LucentAD's adoption in early-detection programs, a key growth area. Additionally, the lack of insurer coverage means private payers or out-of-pocket spending will drive initial uptake—a slower path to mass adoption.

But for investors, these risks are outweighed by the potential. If CMS follows the trajectory of its recent NCD for LAB.00046 Testing for Biochemical Markers for Alzheimer's Disease^[3], it may soon recognize the value of blood-based tests in reducing long-term healthcare costs. Quanterix's first-mover advantage, combined with its clinical trial data, positions it to capture a disproportionate share of the market once reimbursement hurdles are cleared.

Conclusion: A High-Stakes Bet with High Rewards

Quanterix's LucentAD is more than a diagnostic—it's a strategic play to redefine Alzheimer's care. While CMS's current policies constrain its immediate scalability, the company's technological edge, merger-driven growth, and clinical validation efforts create a strong foundation for dominance. Investors who can stomach the regulatory uncertainty may find themselves in a prime position to benefit from what could be the next big breakthrough in neurodegenerative disease management.