CLN - Industry Playbook

C2i Genomics, Twist Bioscience Partner on Whole-Genome Cancer Detection Reference Materials

Industry Playbook: April 2022

C2i Genomics and Twist Bioscience announced a partnership to develop whole-genome cancer reference materials. The partnership aims to deal with a lack of standardized reference samples for analytical validation of whole-genome tests. Oncology has a critical need for advanced technology to help improve treatment decisions, the companies said.

The companies’ reference materials will enable diagnostic labs to better validate and monitor their whole-genome cancer screening and minimal residual disease (MRD) products’ quality. Under the partnership, C2i will integrate Twist’s library preparation into its MRD workflow. The new reference standards and kits will complement existing cancer reference standards and solve the need for lab validation and proficiency testing materials for cancer assays.

The collaboration involves C2i using artificial intelligence to identify a very large set of variants associated with cancer signatures. Twist will synthesize each of these variants to create a whole-genome sequencing-focused set of reference materials. Under the terms of the agreement, the reference standard kits will be available through Twist Bioscience.

BD Acquisition Adds Post-Treatment Monitoring to Its Business

Becton, Dickinson and Company (BD) has acquired Cytognos, a Spanish company that specializes in flow cytometry solutions for blood cancer diagnosis, minimal residual disease (MRD) detection, and immune monitoring research for blood diseases.

The acquisition expands BD’s portfolio of blood cancer diagnostics, immune assessment tests, and informatics to deal with patient, clinician, and care provider needs and to better understand the immune system, immune response, and MRD. MRD monitoring is a key element of the patient care continuum that helps alert clinicians of cancer’s return and spur timely treatment, BD said.

Cytognos acquisition also gives BD exclusive access to advanced assays licensed from the EuroFlow Consortium, a network of hematology and immunology researchers from more than 20 European universities and hospitals. BD has existing license agreements with EuroFlow for multiple existing assays. Currently, Cytognos' in vitro diagnostic products are CE marked and available only in Europe.

Oncocyte and Thermo Fisher Agreement to Expand Access to Precision Oncology

Oncocyte Corporation recently announced a development and co-marketing agreement for two distributed in vitro diagnostic (IVD) assays on Thermo Fisher Scientific’s Ion Torrent Genexus System. The agreement also grants Oncocyte rights to develop future companion diagnostics on the Genexus System.

Under the terms of the collaboration, Oncocyte will clinically validate Thermo Fisher’s existing Oncomine Comprehensive Assay Plus on the Genexus System, with an eye toward IVD clearance for use in tumor profiling and future submissions as a companion diagnostic. As an IVD, the more than 500-gene assay will initially be able to provide physicians with information about patients’ tumors to assist with selecting targeted therapies in accordance with established clinical evidence, applicable clinical trials, and future approval.

Oncocyte also will develop its 27-gene expression DetermaIO test as a distributed kit on the Genexus System. DetermaIO may predict response to immuno-oncology therapies based on data demonstrating potential pan-cancer utility and improvement over current standard-of-care tests.

According to Oncocyte officials, up to 44% of newly diagnosed cancer patients may be eligible for immuno-oncology therapies, with additional patients potentially benefiting from other precision medicines. But many patients’ tumors are never sequenced to determine if they may benefit from these targeted treatments. Expanding available IVDs and developing them on instruments that make sequencing-based testing simple will benefit patients.

Thermo Fisher officials said the agreement with Oncocyte to validate and codevelop new IVD assays expands access to genomic profiling and expands the benefits of precision medicine to more patients.

Deal to Result in Easier High Molecular Weight DNA Extraction

Hamilton, a liquid handling and laboratory automation technology company, announced a collaboration with PacBio to offer a walk-away automation solution for high molecular weight (HMW) DNA extraction.

HMW DNA extraction is a sophisticated and typically manual laboratory workflow. HMW DNA is a prerequisite for long-read sequencing libraries using third-generation sequencing technology platforms from PacBio.

The collaboration will leverage PacBio’s highly differentiated Circulomics sample prep products that enable genomic workflows. The companies will work on a biologically verified method for running PacBio’s Circulomics Nanobind KF CBB Big DNA Kit on technology that extracts high-quality and highly pure HMW DNA from various human, animal, plant, and microbial samples.

Long-read sequencing technologies can resolve repetitive genomic structures that are challenging to determine with short-read sequencing. Empowered by automated HMW DNA extraction, long-read sequences may increase diagnoses of diseases that involve repeat expansions and structural variations.
These include Huntington’s, Parkinson’s, and Alzheimer’s diseases and genetic disorders.

Among Hamilton’s and PacBio’s collective goals is easier sample preparation, which PacBio officials said is often underappreciated and will ease important applications in genomics and in the healthcare setting.

Biocartis and Ophiomics to Collaborate on Liver Cancer Test

Biocartis Group and Ophiomics have announced a collaboration focused on commercialization of HepatoPredict, a prognostic gene expression signature test to identify patients who will benefit from liver transplants. HepatoPredict will be distributed by Biocartis in Europe as a manual kit mainly for centralized expert laboratories.

Retrospective validation has shown the test increased the number of patients that can benefit from curative-intent transplantation by 32%. Further prospective and retrospective validation is ongoing, the companies said. Biocartis officials said that availability of a manual kit version of the Ophiomics test allows the company to help patients generate commercial traction immediately.

While the partnership will initially focus on Biocartis’s commercialization of the manual kit in Europe, it also aims to include development of a fully automated version of the test on Biocartis’ decentralized Idylla platform.