Invivoscribe Launches Commercial Shipments of PrepQuant™ Systems for High-Sensitivity MRD Sample Preparation

Invivoscribe Begins Commercial Shipments of PrepQuant™ System to Advance High-Sensitivity MRD Testing

Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, has announced the start of commercial shipments of its PrepQuant™ System in North America. The milestone marks an important step in the evolution of the platform, which was first introduced at the American Association for Cancer Research (AACR) Annual Meeting in April 2026. Following development and validation, PrepQuant is now moving into commercial deployment, giving laboratories access to an automated solution designed to improve the preparation of nucleic acid samples for highly sensitive molecular testing.

The launch represents an expansion of Invivoscribe’s capabilities beyond diagnostic assays and testing services into laboratory instrumentation. With the PrepQuant System, the company is addressing a critical upstream challenge in molecular diagnostics: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma sample volumes.

As molecular testing becomes increasingly sensitive, the quality and quantity of nucleic acid entering an assay can have a significant impact on the ability to identify rare disease-associated molecules. This is particularly relevant to MRD testing, where the objective is to detect extremely low levels of residual cancer following treatment.

PrepQuant is designed as an assay-agnostic platform capable of producing concentrated genomic DNA and cell-free DNA (cfDNA) that can be used across a broad range of downstream molecular workflows. These include next-generation sequencing (NGS), capillary electrophoresis, quantitative polymerase chain reaction (qPCR), and digital PCR applications. The platform is intended to provide laboratories with a standardized approach to sample preparation while supporting the growing demand for highly sensitive molecular analyses.

Sample Preparation Is Fundamental to MRD Sensitivity

The increasing adoption of MRD testing in precision oncology is placing greater emphasis on every stage of the testing workflow. While analytical sensitivity remains an important consideration when selecting an MRD assay, the process begins well before the molecular analysis itself.

MRD testing often requires the identification of very small quantities of tumor-derived genetic material within a much larger background of normal DNA. Increasing the amount of starting material can potentially provide more molecules for analysis, but processing larger sample inputs can introduce additional operational challenges.

Laboratories must consider extraction efficiency, nucleic acid recovery, concentration, quantification, processing time, and workflow consistency. When these activities are performed using separate instruments, protocols, or manual procedures, each additional step can increase hands-on requirements and create opportunities for variation.

For laboratories processing growing numbers of samples, fragmented workflows can also create challenges related to throughput and operational efficiency. Repeated transfers between instruments may require additional technician time and can increase the potential for sample loss or handling errors.

These challenges helped inform the development of PrepQuant through operational experience gained across LabPMM, Invivoscribe’s global network of clinical laboratories.

The underlying principle is straightforward: molecular testing cannot detect what the laboratory does not successfully recover from the original sample.

Consequently, improving sample preparation can be an important component of building reliable and scalable high-sensitivity molecular testing workflows.

Integrating Extraction, Concentration, and Quantification

The PrepQuant System is designed to consolidate several important sample-preparation functions into a single automated platform. Rather than requiring laboratories to manage separate protocols and instruments for extraction, concentration, and quantification, PrepQuant brings these activities together within a standardized workflow.

This integrated approach is intended to reduce manual intervention and simplify laboratory operations. By automating multiple steps, the system may help laboratories reduce hands-on labor and sample handling while improving consistency between samples.

The platform is also designed to potentially reduce the operational complexity associated with multiple pieces of laboratory equipment. Consolidating workflows may help laboratories manage bench-space requirements and streamline processes as testing volumes increase.

PrepQuant is designed to generate highly concentrated genomic DNA and cfDNA suitable for multiple downstream molecular technologies. Its compatibility with NGS, capillary electrophoresis, qPCR, and digital PCR allows the platform to support a variety of testing strategies rather than being restricted to one particular assay.

The system has been designed and validated for blood, plasma, and bone marrow samples, while additional sample types are currently under development. This broader development strategy could allow Invivoscribe to expand the platform into additional molecular testing applications over time.

Supporting the Expansion of Molecular Testing

The commercial introduction of PrepQuant is also part of Invivoscribe’s broader effort to standardize molecular testing workflows.

MRD testing has become increasingly important in oncology because it can provide information about disease burden that may not be apparent through conventional clinical assessments. Sensitive molecular technologies can identify residual disease at very low levels, potentially supporting treatment monitoring, disease assessment, and the evaluation of therapeutic response.

However, as testing becomes more sophisticated, laboratories must address challenges across the complete testing continuum. Standardizing only the final analytical assay may not be sufficient if upstream sample-processing steps introduce substantial variation.

PrepQuant extends Invivoscribe’s standardization strategy upstream of molecular analysis. The system complements the company’s existing capabilities in MRD assays, bioinformatics, and global clinical laboratory testing.

By combining standardized sample preparation with sensitive molecular assays and data analysis capabilities, Invivoscribe is positioning PrepQuant as part of a broader laboratory ecosystem rather than simply as an independent instrument.

Automation may become increasingly important as molecular testing volumes rise. Standardized automated workflows can help laboratories manage larger numbers of samples while reducing dependence on manual processes. They may also provide greater consistency across research laboratories, reference laboratories, and clinical testing environments.

Addressing the Needs of Modern Precision Oncology

The development of PrepQuant reflects a broader trend within precision medicine: the need to optimize the entire diagnostic workflow as molecular technologies become more sensitive.

In highly sensitive testing, relatively small differences in sample processing can have important implications for the amount and quality of genetic material ultimately available for analysis. Efficient recovery of nucleic acids is therefore an essential component of maximizing the value of sophisticated molecular assays.

Jeff Miller, CEO and CSO of Invivoscribe, emphasized the importance of looking beyond analytical sensitivity when developing MRD testing workflows.

“As precision oncology advances and MRD testing becomes mainstream, laboratories cannot focus on analytical sensitivity alone,” Miller said. “The ability to generate reliable molecular data begins upstream, with how the sample is processed and how effectively the available nucleic acid is recovered and consistently quantified.”

According to Miller, PrepQuant reflects Invivoscribe’s broader perspective that standardization across the testing continuum will become increasingly important as molecular MRD testing becomes more widely integrated into disease monitoring and the assessment of new therapies.

This approach recognizes that diagnostic performance depends on more than the assay itself. Sample collection, extraction, concentration, quantification, molecular analysis, and data interpretation all contribute to the final result.

Commercial Deployment Begins in North America

Invivoscribe has now begun delivering initial PrepQuant Systems to customers across North America. The commercial shipments represent the transition of the platform from development and validation into routine laboratory deployment.

European availability is expected to begin in early 2027, expanding access to the technology beyond the North American market.

The company is also developing additional PrepQuant kits designed to broaden the platform’s capabilities and address a wider range of molecular testing workflows. Future expansion of the kit portfolio could increase the number of applications and sample types supported by the system.

The assay-agnostic design provides Invivoscribe with an opportunity to position PrepQuant as a flexible laboratory platform capable of supporting different molecular testing technologies. This flexibility may be particularly relevant for laboratories that operate multiple testing workflows or need to adapt their infrastructure as new molecular assays are introduced.

The commercial launch of PrepQuant comes at a time when precision oncology and MRD testing are moving toward increasingly sensitive and standardized laboratory workflows. As clinicians and researchers seek to identify increasingly small quantities of disease-associated genetic material, efficient sample preparation is becoming an important part of the overall testing strategy.

By integrating extraction, concentration, and quantification, Invivoscribe aims to simplify sample preparation while improving workflow standardization and scalability. The platform’s compatibility with genomic DNA and cfDNA, combined with support for multiple downstream molecular technologies, gives it potential applications across research and clinical testing environments.

The company’s continued development of additional PrepQuant kits is expected to further expand the platform’s utility. Together with Invivoscribe’s existing MRD assays, bioinformatics capabilities, and laboratory network, the system represents another component of the company’s strategy to support the broader adoption of precision molecular diagnostics.

Laboratories interested in purchasing the PrepQuant System, obtaining a quotation, or learning more about commercial availability can contact Invivoscribe at inquiry@invivoscribe.com.

About Invivoscribe

Invivoscribe® is a global, vertically integrated biotechnology company dedicated to Improving Lives with Precision Diagnostics®. For more than 30 years, Invivoscribe has advanced precision medicine by providing high-quality standardized reagents, assays, bioinformatics tools, and clinical testing services, while supporting pharmaceutical partners through clinical trials, companion diagnostic development, and global regulatory expertise. With the launch of the PrepQuant System, the Invivoscribe ecosystem now includes instrumentation, extending the company’s standardization efforts into the critical pre-analytical workflows that support accurate and reproducible molecular testing.

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