Countable Labs Sets a New Standard in Molecular Testing for Hematologic Malignancy Clinical Applications

New Ancora Assays for Oncology Produce Precision Results With MRD-grade Sensitivity, Delivering the Full Biological Picture For Every Sample

PALO ALTO, Calif.--(BUSINESS WIRE)--Countable Labs, the developer of Countable PCR, a breakthrough single-molecule PCR technology redefining how science measures biology, announced the company’s entry into the clinical market with its new Ancora assays for oncology applications. These assays leverage Countable PCR technology to quantify samples with absolute precision, delivering complete, unambiguous molecular answers without the limits of legacy PCR methods.

Historically, monitoring diseases like CML and AML involved trade-offs inherent to legacy PCR-based testing, including limited dynamic range, specimen constraints from single-target testing, reliance on standard curves rather than direct molecule counts, and an inability to phase co-mutations while also requiring precise breakpoints — factors leading to workflow and analysis complexities, and obscured results. Powered by Countable PCR, Ancora assays for oncology are designed to eliminate these trade-offs and more, giving molecular pathology laboratories and pharmaceutical companies developing therapies for AML, CML, and other blood cancers a single assay system for standardized, absolute quantification in one reaction.

“Molecular laboratories and pharmaceutical companies need standardized solutions with complete detection, MRD-grade sensitivity, and fast, unambiguous results,” said Giovanna Prout, Chief Executive Officer at Countable Labs. “The Ancora assays for oncology are our first set of clinical solutions built on Countable PCR technology, offering the sensitivity to detect unique features and residual disease others may miss. We plan to extend this platform across a broad range of oncology applications, including solid tumor applications and liquid biopsy.”

With roughly 30 million single-molecule compartments per reaction, the assays support a wide dynamic range without dilution or repeat runs, and Countable PCR’s zero dead volume feature means that a limited sample can be used to its fullest capacity. That same compartment density drives sensitivity: the Ancora BCR::ABL1 assay, for example, is designed to detect down to 0.0007% at one million ABL1 copies, beyond MR5.0, critical for deep molecular response and trial endpoints evaluation. Direct, absolute molecule counting removes the need for standard curves. The result is reproducibility, from run-to-run, operator-to-operator, instrument-to-instrument, and site-to-site, which is critical for longitudinal monitoring, method transfer, multisite studies, and both centralized and decentralized testing. Results are available in as little as three hours.

"In our benchmarking work, the biggest difference we saw with Countable PCR was the precision,” said Pamela Ward, Ph.D., Associate Professor Clinical Pathology at the University of Southern California. “We measured coefficients of variation, which were substantially tighter than what we see with conventional FDA-approved RT-PCR. When you're tracking a patient's molecular response over time, that kind of reproducibility matters."

Countable PCR detects targets using a highly specific combinatorial color-coding system in which each call is confirmed by detection of an unambiguous optical signature, allowing the assay to resolve fusion partners and phase co-mutations within a single reaction, without knowing exact breakpoints. Clinical labs can combine the relevant mutations and fusions they need into one focused reaction instead of splitting samples across many, preserving precious samples, and confirming presence of molecularly associated targets. This approach is particularly valuable for cancer applications where co-mutations are common but can be difficult to resolve.

“Fulfilling exhaustive RT-PCR requests for KMT2A and other leukemia fusions is often hindered by limited sample volumes. Countable PCR overcomes this barrier through highly multiplexed, high-throughput assays,” said Dongbin Xu, Ph.D., Vice President, Laboratory Director at HematoLogics, Inc., a diagnostics service laboratory. “By seamlessly handling both low-volume inputs for initial multi-target screening and high-volume inputs for precise disease monitoring of a specific target, it offers an exceptionally versatile diagnostic platform for us and our needs.”

Introducing Ancora Assays for Oncology

Ancora assays for oncology are designed to enable labs to get the most data from every sample, with a simple workflow. Straightforward, counting-based data analysis allows labs to feel confident in standard, reproducible quantification while seeing every variant.

This portfolio provides a complete ecosystem from assay design to the Countable PCR setup, to automated analysis and reporting. Multiple assays including BCR::ABL1, KMT2A, NPM1, and KIT D816V, are available for pre-order at countablelabs.com/heme-oncology with estimated delivery by year end. All assays are immediately available to be run through Countable Labs’ services laboratory.

• Ancora BCR::ABL1 Assay is used to detect all four transcripts (e14a2, e13a2, e1a2, e19a2) quantified alongside the ABL1 reference, with no separate typing step at baseline and no assay switch at follow-up, reaching 0.0007% IS at ≥1M ABL1 copies
• Ancora KMT2A-r Assay is used for detection and absolute quantification of KMT2A rearrangements covering 18 fusion transcripts across the 6 most common partners
• Ancora NPM1 Mutation Assay simultaneously captures Type A, B, and D mutations alongside an ABL1 reference directly from RNA
• Ancora KIT D816V Assay is used to detect and quantify the KIT D816V variant down to 0.015% VAF and the KIT Wild-Type allele simultaneously

Two additional assays for PML:RARA and BCR-ABL TKI are being developed and will be available in the coming months for pre-order and are immediately available via services. Countable Labs offers flexible paths to bring this kind of molecular monitoring to labs who need it. Labs without access to a Countable PCR instrument can choose from several options, including demo placements, short- and long-term instrument rentals, and custom programs built around a lab's budget and timeline.

Countable Labs continues to develop additional assays across heme-oncology, with further indications planned. Organizations with needs beyond the assays listed above are encouraged to contact Countable Labs — the company works with labs and pharmaceutical partners on custom targets, inputs not covered by current kits, as well as on sensitivity, input, or workflow challenges in existing assays. Countable Labs also supports collaborations and co-development projects. To start a conversation, visit countablelabs.com/heme-oncology.

Countable Labs shared details today about the Ancora assays for oncology during a webinar available on demand sponsored with Association for Molecular Pathology (AMP) Online Workshops, featuring the experiences of Drs. Ward and Xu. The company will also present data and exhibit at the AMP Annual Meeting & Expo taking place November 10-14, 2026, in Seattle, Wash. Visit Countable Labs in booth #943 or learn more about Ancora assays for oncology by attending our poster sessions or workshop. Learn more at Countable Labs’ event page.

About Countable Labs

Countable Labs is transforming how biology is measured, bringing single-molecule precision to cell and gene therapy, oncology, molecular diagnostics, and other applications that demand the highest analytical performance. Countable PCR delivers at least 10 times the sensitivity of conventional PCR, with dynamic range and quantitative accuracy that existing digital PCR and next-generation sequencing approaches have not achieved, enabling detection and quantification of rare targets with a level of confidence that fundamentally changes what's measurable. Founded in 2019 and headquartered in Palo Alto, Calif., Countable Labs is privately held and backed by ARCH Venture Partners, F-Prime Capital, and Primer Ventures. Visit www.countablelabs.com to learn more or follow the company on LinkedIn or YouTube.

Countable Labs’ current products are for Research Use Only.