Anthem Blue Cross and Blue Shield Establishes Commercial Coverage for LucentAD® Complete; Quanterix to Present New Data Highlighting Multi-Analyte Advantages

Key Terms

immunoprecipitation mass spectrometry technical

A laboratory method that first uses an antibody like a targeted fishing hook to pull a specific protein and its attached partners out of a complex mixture (immunoprecipitation), then identifies and measures those captured molecules by their precise masses (mass spectrometry). Investors care because the technique reveals which proteins interact, confirms drug targets or biomarkers, and provides molecular evidence used to support research progress, partnerships, and regulatory or clinical claims.

ip-ms technical

Immunoprecipitation–mass spectrometry (IP‑MS) is a laboratory technique that uses an antibody like a fishing hook to pull a specific protein or protein complex out of a biological sample, then identifies and measures those proteins using mass spectrometry. It matters to investors because it is a common way biotech and pharma companies validate biological targets, discover drug interactions, or provide evidence for how a therapy works, which can affect the scientific credibility behind product development.

clia-licensed regulatory

A CLIA-licensed facility has met U.S. federal requirements under the Clinical Laboratory Improvement Amendments (CLIA) to perform testing on human samples. Think of it like a safety and quality inspection certificate for a medical testing lab: it shows the lab follows rules for personnel qualifications, equipment, quality control, and result accuracy. For investors, CLIA status signals regulatory compliance that affects a lab’s ability to sell test results, obtain reimbursements, and avoid regulatory penalties.

iso 15189-accredited regulatory

A laboratory that is ISO 15189-accredited has been independently certified to meet international standards for medical laboratory competence and quality management, covering everything from staff qualifications and equipment calibration to documentation and result reporting. For investors, the accreditation is like a stamped quality badge: it signals that test results are reliable, processes are controlled, and regulatory risks and repeat testing costs are lower, which can affect a diagnostic provider’s reputation, contracts, and revenue stability.

preclinical alzheimer’s disease medical

A stage in Alzheimer’s disease when biological signs of the condition—such as abnormal brain proteins or changes seen on scans or in biomarkers—are present but cognitive symptoms like memory loss have not yet appeared. It matters to investors because therapies and diagnostics that detect or modify disease at this silent stage can change the size and timing of potential markets and the design and regulatory path of clinical trials, similar to finding damage in a building before visible cracks appear.

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Beginning July 1, 2026, Anthem Blue Cross and Blue Shield medical policies support eligible blood-based biomarker testing

New peer-reviewed and AAIC data reinforce the clinical value of Quanterix's LucentAD® Complete multi-biomarker blood

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (NASDAQ: QTRX), a global leader in precision biomarker science, today announced a series of milestones that significantly advance the clinical adoption of blood-based Alzheimer’s testing. Together, these milestones reinforce the growing role of LucentAD^® Complete, Quanterix’s five-analyte ATN(I) algorithmic blood test, in helping clinicians evaluate Alzheimer’s disease through a comprehensive, blood-based assessment.

The announcements include:

• Anthem Blue Cross and Blue Shield eligible members will be the first commercially insured patients in the United States to benefit from medical policy coverage supporting blood-based biomarker testing for Alzheimer’s disease.
• Publication of new peer-reviewed study comparing LucentAD^® Complete against an immunoprecipitation mass spectrometry (IP-MS) method on a shared patient cohort, demonstrating strong diagnostic parity while combining five biomarkers across amyloid pathology, tau pathology, neurodegeneration, and neuroinflammation.
• New clinical data presented at the Alzheimer’s Association International Conference (AAIC) 2026 highlighting the role of multi-biomarker testing in supporting patient triage and supporting earlier clinical decision making.

“Blood-based Alzheimer’s diagnostics are entering an important new chapter,” said Everett Cunningham, President and CEO of Quanterix. “Commercial reimbursement, peer-reviewed rigorous validation and expanding real-world evidence together represent the foundation required to grow clinical adoption. We believe these milestones reinforce the value of comprehensive multi-marker assessment and move us closer to making earlier, more accessible Alzheimer’s diagnosis a reality.”

Anthem Medical Policy Supports Blood-Based Biomarker Testing

Beginning July 1, 2026, members covered under Anthem Blue Cross and Blue Shield medical policies can receive coverage for qualifying blood-based biomarker testing, including Quanterix’s LucentAD^® Complete, when medical necessity criteria are met. The full policy, LAB.00046: Testing for Biochemical Markers for Alzheimer Disease, outlines the clinical criteria for coverage.

As the second-largest health insurer in the United States, Anthem provides medical coverage to approximately 40 million members across 14 states, representing a significant milestone in expanding patient access to blood-based Alzheimer’s diagnostics.

LucentAD^® Complete aligns with the growing clinical movement toward earlier, less invasive evaluation of patients with cognitive impairment while providing clinicians with a broader assessment across amyloid pathology, tau pathology, neurodegeneration and neuroinflammation.

Peer-Reviewed Publication Reinforces the Clinical Value of LucentAD^® Complete

Quanterix also announced publication of a new study in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, published on behalf of the Alzheimer’s Association.

The publication, “Comparison of a Multi-Analyte Algorithmic Immunoassay Blood Test with Immunoprecipitation Mass Spectrometry for the Detection of Amyloid Pathology,” evaluated LucentAD^® Complete alongside an algorithmic IP-MS approach using a shared patient cohort.

Among the study findings:

• Performance demonstrated high diagnostic parity with IP-MS across shared patient samples
• The multi-analyte algorithm reduced diagnostic ambiguity by approximately three-fold compared with standalone plasma p-Tau217 substantially reducing intermediate or indeterminate results

The test’s multi-marker algorithm provides both an integrated Alzheimer’s risk score and individual biomarker results, giving clinicians a broader, more actionable view of disease biology beyond amyloid status alone.

The authors conclude that multi-analyte algorithmic blood testing can deliver performance comparable to mass spectrometry while providing additional biological insight that may support more comprehensive clinical management and future reimbursement models.

New AAIC Data Highlights Real-World Clinical Utility

At AAIC 2026, Quanterix will present multiple studies demonstrating the clinical utility of comprehensive blood-based biomarker testing.

Principal Investigator and Director of the University of Florida Precision Health Research Center Dr. Carla VandeWeerd will present results from a prospective community screening study involving 520 adults aged 55 years and older in The Villages^®, Florida. The study evaluated a two-stage screening approach combining cognitive assessment with blood-based biomarker testing in a primary care setting. Biomarker adjudication identified approximately 20% of cognitively normal participants as having evidence of preclinical Alzheimer’s disease while helping inform referral decisions among cognitively impaired individuals.

Three additional posters from Quanterix will be presented at AAIC. Together, these studies further demonstrate how evaluating diverse biological signals provides enhanced detection of early Alzheimer's and a more comprehensive framework for guiding patient care.

“The data we’re presenting at AAIC reinforces an emerging principle in Alzheimer’s diagnostics: evaluating multiple biological pathways, gives clinicians more actionable information than any single biomarker alone” said Everett Cunningham. “By integrating amyloid, tau, neurodegeneration, and neuroinflammation into a single validated algorithmic assessment, LucentAD^® Complete is designed to support more confident clinical decision-making across the Alzheimer’s disease continuum.”

Preview of Future Neurology Innovation

Visitors to Booth #1201 at AAIC will also receive an exclusive preview of upcoming Quanterix innovations that further expand the company’s precision biomarker portfolio. Product experts will discuss the anticipated impact of these new technologies on Alzheimer’s research, clinical development and patient care ahead of future product announcements.

Researchers interested in expanding neurology biomarker programs can also learn about Quanterix Accelerator Laboratory, the company’s CLIA-licensed, ISO 15189-accredited laboratory providing contract biomarker testing services for pharmaceutical, biotechnology and academic partners.

Visit Quanterix at Booth #1201 during AAIC 2026 to learn more.

About Quanterix

Quanterix is a global leader in precision biomarker science, making biology measurable to deliver earlier insights and support breakthroughs in disease research, diagnostics, and drug development. Its Simoa^® technology delivers industry-leading sensitivity, allowing researchers to detect and quantify biomarkers in blood and other fluids at concentrations far below traditional limits. Through the acquisition of Akoya Biosciences, Quanterix Spatial solutions deliver high-plex, quantitative protein analysis in tissue at single-cell resolution. Combined with Accelerator Laboratory services, Quanterix gives researchers the tools and expertise to translate discovery into precision diagnostics. Learn more at www.quanterix.com.

About LucentAD^® Complete

LucentAD^® Complete is Quanterix’s multi-analyte algorithmic blood test designed to support the evaluation of Alzheimer’s disease biology through a comprehensive assessment of the ATN(I) framework. The test measures five blood-based biomarkers associated with amyloid pathology, tau pathology, neurodegeneration, and neuroinflammation, combining these results into a validated algorithmic Alzheimer’s disease risk score while also providing individual biomarker results. By delivering a more comprehensive view of disease biology from a simple blood sample, LucentAD^® Complete helps support earlier, more informed clinical decision-making and provides information to assist clinicians across the Alzheimer’s disease continuum.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Statements included in this press release that are not historical in nature or do not relate to current facts are intended to be, and are hereby identified as, forward-looking statements for purposes of the safe harbor provided by Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include, among other things, statements related to our expectations about the clinical adoption of, reimbursement for, and utility of our products. Words and phrases such as “may,” “approximately,” “continue,” “should,” “expects,” “projects,” “anticipates,” “is likely,” “look ahead,” “look forward,” “believes,” “will,” “intends,” “estimates,” “strategy,” “plan,” “could,” “potential,” “possible” and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are subject to certain risks and uncertainties that are difficult to predict with regard to, among other things, timing, extent, likelihood and degree of occurrence, which could cause actual results to differ materially from anticipated results. Such risks and uncertainties include, among others, the following possibilities with respect to Quanterix’s future business, operations, strategy and financial performance: risks related to the impact of changes in U.S. government policies, including impacts of tariffs and reductions in federal research funding; risks associated with the anticipated timing for launch of, and features of, Quanterix’s next-generation instruments to upgrade its existing platforms; risks related to Quanterix’s ability to improve existing diagnostics and develop new diagnostic tests and tools; risks related to Quanterix’s ability to successfully penetrate the diagnostics market; risks related to Quanterix’s ability to retain and expand its customer base and achieve sufficient market acceptance of its products; risks related to the ability of Quanterix’s contract manufacturers and suppliers to reliably and consistently manufacture and supply our instruments; risks that Quanterix may fail to realize the anticipated benefits and synergies of its recent acquisitions of Emission, Inc. and Akoya Biosciences Inc.; risk that integrating Quanterix’s business with that of Akoya could be more difficult, costly or time-consuming than expected; risks that Quanterix’s estimates regarding expenses, future revenues, capital requirements, and needs for additional financing could be incorrect; risks related to Quanterix’s ability to maintain effective internal control over financial reporting and disclosure controls and procedures; and risks related to defects or other quality issues in Quanterix’s products that could lead to unforeseen costs, product recalls, adverse regulatory actions, negative publicity and litigation. Additional factors that could cause results to differ materially from those described above can be found in the periodic reports filed by Quanterix with the SEC, including the “Risk Factors” sections contained therein, which are available on the SEC’s website at www.sec.gov.

All forward-looking statements, expressed or implied, included in this press release are expressly qualified in their entirety by the cautionary statements contained or referred to herein. If one or more events related to these or other risks or uncertainties materialize, or if Quanterix’s underlying assumptions prove to be incorrect, actual results may differ materially from what Quanterix anticipates. Quanterix cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made and are based on information available at that time. Quanterix does not assume any obligation to update or otherwise revise any forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements were made or to reflect the occurrence of unanticipated events except as required by federal securities laws.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260714466817/en/

Quanterix Media Contact:
Sarah Dolny
media@quanterix.com

Source: Quanterix Corporation