Quanterix Reshapes Sales Strategy, Targets Q4 FDA Decision for Alzheimer’s Blood Test

Quanterix (NASDAQ:QTRX) CEO Everett Cunningham said the company is repositioning its commercial organization and investing in diagnostics and clinical-trial capabilities following the integration of Akoya Biosciences, while acknowledging continued pressure in academic, government and biopharma markets.

Speaking at the Canaccord Genuity Growth Conference, Cunningham said Quanterix completed the acquisition-related integration work in the second quarter, including its enterprise resource planning integration. The company delivered $85 million in revenue synergies over the prior year, he said.

“We’re now focused,” Cunningham said. “Our theme is we’re now investing to grow.”

Commercial execution and market pressures

Cunningham said customer feedback continues to support the differentiation of Quanterix’s spatial biology offerings and its legacy Simoa platform, including across instruments, consumables and clinical-trial services. He noted that Accelerator clinical-trial bookings increased sequentially during the quarter.

However, the company has faced a funding-related headwind in the U.S. academic and government market. In biopharma, Quanterix is seeing roughly the same volume of clinical trials and customer deals, but those deals are smaller, according to Cunningham.

He said some opportunities have gone to competitors, while Quanterix has missed others because it was not engaging the appropriate customers early enough in their decision processes. The company has established a dedicated clinical-trials team of about seven to 10 people to pursue larger opportunities with pharmaceutical customers.

“It takes one or two deals to start to turn that around,” Cunningham said, adding that the company’s clinical-trial bookings were up quarter over quarter.

Quanterix has also revised a post-merger sales strategy that had asked individual representatives to sell spatial products, Simoa products and clinical-trial services. Cunningham said that approach placed too much burden on the commercial organization.

  • Dedicated representatives will now sell spatial offerings.
  • Separate personnel will focus on Simoa offerings.
  • A distinct team will cover the Accelerator clinical-trials business.

Cunningham said the company assessed coverage geography by geography and expects only limited additions to headcount, describing potential incremental hiring as “onesie, twosie globally.” Quanterix also named Jim Gute, formerly of Exact Sciences, as chief commercial officer. Cunningham said Gute brings experience in commercial tools, capital equipment and service sales, including pipeline management and forecasting.

Research tools and diagnostic strategy

While discussing the company’s increased focus on diagnostics, Cunningham said Quanterix intends to maintain a balance between research tools and diagnostic activities. Its first priority is to stabilize and return the research-tools business to growth, he said.

On the clinical-trial side, Cunningham said Quanterix’s low-plex, ultra-sensitive approach is particularly valuable for reproducibility. He cited consistency from lot to lot, plate to plate and laboratory to laboratory as important requirements in Phase II and Phase III clinical trials.

For diagnostics, the company is advancing its LucentAD Complete blood-based test for Alzheimer’s disease. Cunningham said Quanterix filed a 510(k) submission for LucentAD Complete in January and has had “productive conversations” with the U.S. Food and Drug Administration. The company is targeting an FDA decision in the fourth quarter, though he said timing could extend into the first quarter.

Quanterix also has three clinical-utility studies underway with partners, with results expected in the second half. The company plans to use those results in discussions with payers, Cunningham said.

Anthem Blue Cross and Blue Shield began covering blood-based biomarkers, including LucentAD Complete, on July 1, according to Cunningham. He also said the test has a Centers for Medicare & Medicaid Services price crosswalk of $897. Quanterix is assuming payers will honor that price point, although Cunningham said it remains early and volume has not yet materially increased.

Building diagnostic infrastructure

Cunningham said Quanterix hired Geoff Albrecht, a former Quest Diagnostics executive, to lead its diagnostics efforts. The company is building capabilities spanning commercial sales, reimbursement, billing, payer navigation, government affairs and laboratory operations.

Quanterix currently operates a laboratory accepting LucentAD Complete samples and has capacity to accommodate increased testing volumes, Cunningham said. It has also hired two people focused on billing, aiming to make the ordering and payment process easier for providers.

The company plans to file a separate 510(k) submission for an in-vitro diagnostic version of its HD-X instrument in 2027. Cunningham said the filing will include added software and work to improve instrument stability to approximately 98%. If cleared, the product could support a decentralized model in which laboratories use the instrument directly, alongside Quanterix’s centralized testing strategy.

Cunningham said Quanterix is targeting $10 million in diagnostics revenue in 2026 and is pacing toward that objective, with potential upside.

He also highlighted the company’s five-marker LucentAD Complete test as a competitive differentiator. According to Cunningham, the test provides every patient with a quantitative score and has an indeterminate rate of 10% or below, compared with an indeterminate zone of 30% or more for competing tests.

Partnerships, outlook and cash flow

Quanterix plans to combine a focused internal sales effort with partnerships to expand access to LucentAD Complete. Cunningham said its partnership with Tempus AI is intended to support outreach to selected health systems through Tempus’ integration with electronic medical records. He also said the company is pursuing additional reference-laboratory partnerships and cited its existing work with ARUP Laboratories on a single-marker test as an example.

The company expects third-quarter revenue to be roughly flat with second-quarter levels before sequential improvement in the fourth quarter. Cunningham attributed the expected fourth-quarter momentum to commercial changes begun near the end of the first quarter, increased clinical-trial bookings, and newly launched spatial assays.

Quanterix has moved its cash-flow breakeven target from the second half of the current year to sometime next year. Cunningham said confidence in the revised timing is based on the cost discipline demonstrated through the Akoya integration and the company’s planned return to sequential revenue growth.

About Quanterix (NASDAQ:QTRX)

Quanterix Corporation is a life sciences and diagnostics company specializing in ultra-sensitive digital immunoassay platforms. Its proprietary Single Molecule Array (Simoa) technology enables researchers to detect and quantify proteins, peptides and nucleic acids at femtomolar concentrations, offering sensitivity that surpasses traditional immunoassay methods. By translating single-molecule detection into routine laboratory workflows, Quanterix aims to accelerate biomarker discovery and the development of novel diagnostics and therapeutics.

The company’s core product portfolio includes the Simoa HD-1 and HD-X Analyzers, which automate high-throughput digital immunoassays for quantifying low-abundance biomarkers.