Countable Labs Enters Clinical Market With Ancora Oncology Assays Powered by Single-Molecule PCR Technology
Countable Labs, a developer of advanced molecular testing technologies, has announced its entry into the clinical market with the launch of its Ancora assays for oncology applications. The new assays are built on the company’s Countable PCR platform, a single-molecule PCR technology designed to provide absolute molecular quantification and high sensitivity for applications in cancer research, molecular diagnostics and disease monitoring.
The company said the Ancora oncology portfolio is intended to address several limitations associated with conventional PCR-based testing, particularly in the monitoring of hematologic malignancies such as chronic myeloid leukemia (CML) and acute myeloid leukemia (AML). These limitations can include restricted dynamic range, specimen-volume constraints, dependence on standard curves, single-target testing and challenges associated with identifying and phasing multiple molecular alterations.
Countable Labs said its new approach is designed to enable molecular pathology laboratories and pharmaceutical companies developing cancer therapies to obtain standardized molecular measurements from a single reaction. The platform is intended to provide absolute quantification, high sensitivity and reproducible results while reducing the amount of patient sample required for testing.
“ M olecular laboratories and pharmaceutical companies need standardized solutions with complete detection, MRD-grade sensitivity, and fast, unambiguous results,” said Giovanna Prout, chief executive officer of 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.”
Prout added that Countable Labs plans to expand the technology into additional oncology applications, including solid tumors and liquid biopsy.
Countable PCR Designed to Address Conventional Testing Limitations
PCR and reverse-transcription PCR have become important technologies for detecting and monitoring molecular abnormalities associated with cancer. However, conventional approaches can involve technical and workflow limitations when laboratories need to identify multiple targets, monitor very low levels of residual disease or work with limited quantities of patient material.
Countable Labs designed its PCR technology around single-molecule analysis. According to the company, approximately 30 million single-molecule compartments are generated during each reaction. This high compartment density is intended to provide a broad dynamic range without requiring dilution or repeat testing.
Another feature highlighted by the company is its zero-dead-volume design. Countable Labs said this enables laboratories to use limited clinical specimens more efficiently, an important consideration for oncology testing where available sample material can be restricted.
The company also said Countable PCR uses direct molecule counting rather than relying on standard curves to establish quantification. By directly counting molecular targets, the platform is designed to generate absolute measurements and improve reproducibility across testing environments.
This could be particularly relevant for longitudinal monitoring, where patients may undergo repeated molecular testing over months or years. Consistency between testing runs, operators, instruments and laboratory sites can be important when small changes in molecular disease burden need to be interpreted over time.
According to Countable Labs, results can be available in as little as three hours, providing laboratories with a rapid testing workflow while maintaining the platform’s emphasis on molecular sensitivity and quantification.
High Sensitivity for Minimal Residual Disease Monitoring
Minimal residual disease (MRD) monitoring is an important application of molecular testing in hematologic cancers. MRD refers to small amounts of disease that remain after treatment and may not be detectable through conventional clinical assessments.
Highly sensitive molecular assays can help researchers and clinicians evaluate treatment response and identify residual disease at very low levels. Countable Labs said its Ancora BCR::ABL1 assay is designed to detect disease down to 0.0007% at one million ABL1 copies, a level beyond MR5.0.
The BCR::ABL1 assay is designed to detect four major transcripts — e14a2, e13a2, e1a2 and e19a2 — while quantifying them alongside the ABL1 reference gene. According to the company, the design eliminates the need for a separate transcript-typing step at baseline and avoids switching assays during follow-up monitoring.
Such continuity could be useful in clinical trials and routine disease monitoring because longitudinal assessments require comparable measurements over time. Standardized testing can also be important when pharmaceutical companies evaluate molecular responses as clinical trial endpoints.
Pamela Ward, Ph.D., associate professor of clinical pathology at the University of Southern California, said benchmarking work comparing Countable PCR with conventional FDA-approved RT-PCR showed differences in precision.
“In our benchmarking work, the biggest difference we saw with Countable PCR was the precision,” Ward said. She noted that measured coefficients of variation were substantially tighter than those observed with conventional FDA-approved RT-PCR in the testing performed.
Ward added that reproducibility is particularly relevant when molecular responses are followed over time in individual patients.
Multiplexing Designed to Preserve Limited Samples
Another feature of Countable PCR is its ability to identify multiple molecular targets in a single reaction using what the company describes as a combinatorial color-coding system.
Each molecular call is confirmed through an optical signature, allowing the system to distinguish fusion partners and phase co-mutations without requiring exact breakpoint information.
This approach could have applications in cancers where multiple mutations or gene rearrangements may be present simultaneously. Instead of dividing a limited clinical specimen among multiple separate tests, laboratories can combine relevant targets into a focused reaction.
Preserving sample material can be particularly important in hematologic malignancies, where diagnostic and monitoring specimens may be available in limited quantities. A multiplexed approach can potentially reduce the number of reactions needed while increasing the amount of molecular information obtained from each specimen.
Dongbin Xu, Ph.D., vice president and laboratory director at HematoLogics, Inc., said limited sample volumes can create challenges when laboratories need to perform extensive RT-PCR testing for KMT2A and other leukemia-associated fusions.
Xu said Countable PCR’s high-throughput, multiplexed approach can support both low-volume samples used for initial multi-target screening and larger sample inputs used for precise monitoring of specific molecular targets.
Ancora Oncology Assay Portfolio
Countable Labs said the Ancora oncology portfolio is designed to provide laboratories with a complete workflow covering assay design, Countable PCR setup, automated analysis and reporting.
The company currently lists several assays for pre-order, including BCR::ABL1, KMT2A, NPM1 and KIT D816V. The assays are expected to be delivered by the end of 2026, while all four are already available through Countable Labs’ services laboratory.
The Ancora BCR::ABL1 Assay is designed to identify four BCR::ABL1 transcripts — e14a2, e13a2, e1a2 and e19a2 — and quantify them against the ABL1 reference. Countable Labs said the assay can reach 0.0007% International Scale at at least one million ABL1 copies.
The Ancora KMT2A-r Assay is designed for detection and absolute quantification of KMT2A rearrangements. The assay covers 18 fusion transcripts involving six of the most common fusion partners, providing a multiplexed approach to detecting KMT2A-associated leukemia alterations.
The Ancora NPM1 Mutation Assay is designed to simultaneously detect Type A, Type B and Type D NPM1 mutations alongside an ABL1 reference directly from RNA.
The Ancora KIT D816V Assay is designed to detect and quantify the KIT D816V variant to a reported sensitivity of 0.015% variant allele frequency (VAF), while simultaneously assessing the KIT wild-type allele.
Countable Labs is also developing assays for PML::RARA and BCR-ABL tyrosine kinase inhibitor (TKI) applications. The company said these additional assays are expected to become available for pre-order in the coming months and can already be accessed through its laboratory services.
Supporting Laboratories Without Countable PCR Instruments
To broaden access to the platform, Countable Labs is offering several options for laboratories that do not currently have a Countable PCR instrument.
These options include demonstration placements, short- and long-term instrument rentals and customized programs designed around a laboratory’s budget and implementation timeline. The company said these models are intended to allow laboratories to evaluate and deploy molecular monitoring capabilities without necessarily making an immediate instrument purchase.
Countable Labs is also working with pharmaceutical companies and diagnostic laboratories on custom applications. Organizations with targets or specimen types that are not currently covered by the commercial assay portfolio can work with the company on custom targets, input requirements, sensitivity challenges and workflow optimization.
The company also supports collaboration and co-development projects, reflecting its broader strategy of extending Countable PCR beyond its initial oncology applications.
Expansion Into Additional Oncology Applications
The launch of Ancora assays marks an important step in Countable Labs’ transition from technology development into clinical applications. The company said it intends to expand the portfolio across hematologic oncology while also exploring solid tumors and liquid biopsy.
Liquid biopsy represents a potential area where highly sensitive molecular detection and efficient use of limited samples could be particularly relevant. Detecting tumor-derived molecular signals in blood often requires sensitive analytical technologies because target molecules can be present at very low concentrations.
The company’s focus on direct molecular counting, multiplexing and reproducibility could potentially support applications requiring repeated measurements or highly sensitive detection. However, individual assays will need to be evaluated according to their intended use, analytical performance and applicable regulatory requirements.
Industry Presentation and Clinical Market Development
Countable Labs has shared details of its Ancora oncology portfolio through an on-demand webinar sponsored in collaboration with the Association for Molecular Pathology Online Workshops. The program features presentations and experiences from Ward and Xu concerning the use and benchmarking of Countable PCR technology.
The company is also scheduled to present data and exhibit at the AMP Annual Meeting & Expo, which is planned for November 10–14, 2026, in Seattle, Washington. Countable Labs said it will exhibit at booth 943 and participate in poster sessions and a workshop focused on its Ancora oncology assays.
The company’s entry into the clinical market comes as molecular laboratories and pharmaceutical developers continue to seek testing technologies capable of detecting increasingly small quantities of disease-associated biomarkers. In hematologic malignancies, precise molecular measurements can be important for diagnosis, treatment monitoring, clinical research and assessment of response.
With its Ancora portfolio, Countable Labs is positioning Countable PCR as a platform for absolute molecular quantification across multiple oncology applications. The company’s initial assays target clinically important molecular markers in CML, AML and other hematologic malignancies, while its development pipeline is intended to expand the technology into additional targets and disease areas.
By combining high-density single-molecule compartments, direct molecular counting, multiplex target detection and automated analysis, Countable Labs aims to provide laboratories with a standardized approach to molecular testing. The company expects the technology to support both clinical laboratories and pharmaceutical companies conducting research and development programs that require sensitive, reproducible and longitudinal molecular measurements.
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.