Quanterix announced the launch of its AidaBREAST™ multi‑omic assay, a first‑in‑class test that predicts both 10‑year locoregional recurrence risk and the benefit of radiation therapy for patients with early‑stage, hormone‑receptor positive, HER2‑negative breast cancer.
The assay was built on the company’s Akoya PhenoImager HT platform using Opal chemistry and combines spatial protein expression with targeted next‑generation RNA sequencing. A validation study of 922 patients across four U.S. and Swedish centers demonstrated the assay’s prognostic accuracy for recurrence and its predictive power for radiation‑therapy benefit, capabilities not previously available in a single test.
Quanterix’s acquisition of Akoya Biosciences in 2025 positioned the company to leverage spatial biology in oncology. The breast‑cancer screening market is projected to reach $3.5‑$6.1 billion by 2026‑2033, and the new assay offers a unique, multi‑omic approach that could capture a share of that growth. "PreludeDx's ability to develop a truly novel tool on our PhenoImager HT platform – that also performs reliably and reproducibly across multiple institutions and years of archived tissue, speaks to the immediate opportunity for spatial proteomics in clinical oncology," said CEO Everett Cunningham.
Financially, Quanterix reported Q4 2025 revenue of $43.9 million, a 25% year‑over‑year increase, while Q1 2025 revenue fell 5% to $30.3 million. Gross margins compressed, with GAAP gross margin at 45.7% versus 63% a year earlier and adjusted gross margin at 50% versus 57.7%. Net losses widened to $23.1 million in Q4 and $20.5 million in Q1. The company guided 2026 revenue to $169‑$174 million and expects cash‑flow breakeven in the second half of the year. "Market resource constraints and ongoing market headwinds" were cited by former CEO Masoud Toloue as factors affecting recent performance.
Management highlighted the clinical impact of the new assay. "For the first time, oncologists have a tool that tells them not just how likely a patient is to recur, but whether radiation therapy is actually going to help that specific patient. That is a meaningful shift in how we can better inform treatment decisions," said Karuna Mittal, Senior Director of Research and Development. Cunningham added that the company’s focus on "commercial expansion and operational rigor" will support the launch, noting that its strong research‑tools business and the growing diagnostics opportunity provide a foundation for future growth.
Investors weighed the company’s financial performance and valuation when assessing the announcement. While the product launch signals a strategic expansion into a large oncology market, the recent margin compression, net losses, and guidance for modest revenue growth contributed to a muted market reaction.
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