Combining Whole Genome Sequencing with ppm-Level Sensitivity, MRDVision Sets a New Benchmark in Circulating Tumor DNA Detection

SAN DIEGO: Today, Inocras, a leader in whole genome sequencing (WGS) and bioinformatics, announced MRDVision, its solution for minimal residual disease (MRD) detection, validated to CLIA standards. The assay, previously available for research use only, is now ready for use in clinical settings, redefining the standard in MRD testing by enabling ultra-sensitive detection of circulating tumor DNA (ctDNA) with a simulated limit of detection (LOD) as low as 1 part per million (ppm).

Developed through the integration of Inocras’s comprehensive CancerVision™ WGS cancer profiling platform and Ultima Genomics’ ppmSeq™ technology, MRDVision delivers a breakthrough approach for tracking cancer recurrence and treatment response with unmatched accuracy, efficiency, and cost-effectiveness.

MRDVision takes a distinct approach – tumor whole genome-informed whole-genome cfDNA monitoring, without the need to create patient-specific panels. Unlike existing MRD assays that extract tumor information from whole genome (or whole exome) data only to compress it into a limited gene panel for cfDNA monitoring, MRDVision preserves whole-genome tumor insights and continuously scans the entire cfDNA genome to track ctDNA. This approach streamlines the workflow, enhances efficiency, maintains high accuracy, and delivers faster turnaround times while generating more data per assay.

In its recent clinical validation study using cfDNA samples from post-surgical ovarian and lung cancer patients, MRDVision detected tumor-derived signals in 6% of cases that were not identified by the comparator assay, likely reflecting enhanced sensitivity at low tumor fractions. This improved detection is consistent with MRDVision’s industry-leading limit of detection of 1 part per million (ppm), established through analytical simulations using high tumor mutational burden (TMB) tumors and plasma sequencing depths of 100x.

“By delivering whole genome x whole genome analysis, MRDVision marks a paradigm shift in minimal residual detection,” said Jehee Suh, CEO at Inocras. “The ultra-sensitive MRDVision can empower clinicians to detect recurrence earlier and assess therapy responses with greater precision, potentially changing the standard of care. The assay’s robust data output also supports a wide range of research applications, including drug development and biomarker discovery. Our streamlined, panel-free workflow makes this cutting-edge assay both highly scalable and cost-effective—empowering researchers to expand their studies with confidence, without compromising on quality.”

Key highlights of MRDVision:

• Ultra-sensitive detection: Demonstrated simulated LOD95 of 1 ppm
• High concordance with orthogonal tests: Clinical validation using cfDNA samples from post-surgical ovarian and lung cancer patients showed strong alignment with existing methods while detecting tumor-derived signals even at low tumor fractions.
• Simplified workflow and rapid turnaround: Streamlined process that delivers results quickly and efficiently.
• Cost-effective: More data per assay at a lower cost than traditional panel-based tests.

The results from MRDVision’s clinical validation will be presented at the American Association for Cancer Research annual meeting on April 29, 2024, where Inocras will offer special promotion for MRDVision for the cancer researcher and clinician community. To learn more about this offer, contact Inocras.

About Inocras Inc:

Inocras is an AI-driven company that specializes in delivering critical insights to cancer and rare disease patients through whole genome sequencing and bioinformatics. The company offers its whole genome testing products, CancerVision, RareVision and MRDVision, and provides research services for pharmaceutical and biotechnology companies as well as research organizations through its CAP/CLIA lab, powered by its proprietary, IP-protected bioinformatics pipeline. Inocras is dedicated to unlocking the potential of whole genome data to enable precision health for everyone. For more information, please visit inocras.com and follow the Inocras LinkedIn page.

Fonte: Business Wire