Genentech, a member of the Roche Group, has joined forces with Microbiotica to discover, develop, and commercialize biomarkers, targets, and medicines for inflammatory bowel disease (IBD). Microbiotica, a spinoff of the U.K.’s Wellcome Sanger Institute, was formed to commercialize therapeutics based on the institute’s microbiome research. Under the terms of the agreement, Microbiotica will use its precision metagenomics microbiome platform to analyze patient samples from clinical trials of Genentech’s investigational IBD medicines with the goal of identifying microbiome biomarker signatures of drug response, novel IBD drug targets, and live bacterial therapeutic products.
The Microbiotica platform comprises a comprehensive microbiome culture collection as well as a linked reference genome database that together enable gut bacterial identification at clinical trial scale. The platform also uses artificial intelligence techniques to match microbiome signatures with phenotype. The company continues to add to the platform’s collection and database through an industrial culturing and sequencing pipeline that provides clinical trial samples for strain-level identification of bacteria. Additionally, the availability of the physical culture collection enables biological evaluation of bacteria in propri-etary translational models including humanized microbiome mouse models.
“This collaboration brings together a world-class pipeline of investigational IBD medicines from Genentech with the world-class microbiome capability of Microbiotica,” said Mike Romanos, PhD, CEO of Microbiotica. “We are excited by the opportunity to work with Genentech scientists in order to bring precision metagenomics into the clinical arena for the first time, enabling us to develop biomarkers and medicines for the benefit of patients.”
Thermo Fisher Launches Precision Medicine Center
Thermo Fisher Scientific has opened its U.S. Precision Medicine Science Center (PMSC) in Cambridge, Massachusetts. The center offers access to advanced genomic, proteomic, and metabolomic technologies and expertise to help collaborators develop analytical workflows that generate precise molecular profiles of patients. In addition to providing access to these technologies, PMSC’s team of in-house scientists helps partners develop standard protocols that enable them to compress research and development timelines and quickly progress from biomarker discovery to assay development. The team includes Thermo Fisher experts in biochemistry, mass spectrometry, molecular biology, and data science. “For health and science innovators, a bottleneck exists today between the discovery of biomarkers and their widespread use at the point of care,” said Emily Chen, PhD, senior director at PMSC. “Our goal at the PMSC is to remove that bottleneck and help scientists and physicians reduce the time it takes to demonstrate clinic validity and utility.”
Florida’s Largest Health Plan to Cover Interpace Diagnostics’ Thyroid Tests
Interpace Diagnostics Group has received coverage from Blue Cross Blue Shield of Florida (Florida Blue), the largest health plan in the state, for its combination thyroid molecular-based tests, ThyGenX and ThyraMIR. These assays are now covered for Florida Blue’s more than 3 million members for thyroid nodules deemed indeterminate by standard cytopathology analysis. Traditionally, thyroid surgery has been recommended when thyroid nodule biopsy results are indeterminate, however, 70%-80% of these nodules turn out to be benign post-surgery. Molecular testing using the ThyGenX-ThyraMIR combination has been shown to reduce the rate of these unnecessary surgeries. ThyGenX is designed to rule in patients by using next-generation sequencing to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, while ThyraMIR offers the rule-out capabilities of a micro-RNA classifier, thereby providing physicians with clinically actionable test results. Based on Interpace’s current performance, more than 90% of ThyGenX cases are reflexed to ThyraMIR for additional assessment.
Qiagen, Freenome Join Forces on Immunotherapy Co-Diagnostics
Qiagen and Freenome are partnering with the aim of developing faster, more accurate molecular diagnostic tests that predict whether a patient will benefit from immune-oncology therapies. The collaboration will leverage Freenome’s artificial intelligence genomics platform, which sequences and analyzes multiple analytes to evaluate genomic, proteomic, and epigenetic changes and integrates datasets derived from those changes to deliver clinically actionable recommendations. Qiagen will contribute its bioinformatics platforms to the partnership, as well as its universal solutions for next-generation sequencing (NGS) and GeneReader NGS system. One project the two companies will focus on specifically is developing an NGS tumor mutational burden (TMB) assay that determines the level of TMB from a blood sample and overcomes the challenge posed by the low levels of tumor DNA present in blood. Eventually, Qiagen and Freenome plan to co-market the tests they develop to pharmaceutical companies working on immunotherapies.
Sophia Genetics Buys Interactive Biosoftware
Sophia Genetics has completed the acquisition of French-based tech company Interactive Biosoftware, the creator of Alamut, a decision support software for clinical genomic data interpretation. Interactive Biosoftware was founded in 2007 by a group of medical and computer scientists focused on practical software applications for healthcare and life sciences. The company’s platform, Alamut, is currently deployed in more than 450 hospitals and complements Sophia Genetics’ technology for clinical genomics, Sophia AI, which itself is used by a global network of 480 institutions from 60 countries. By connecting the capabilities of the two solutions, Sophia Genetics hopes to make data-driven medicine more widely accessible to patients. “Both Sophia AI and Alamut are technologies trusted by the healthcare community and focus on patient-centric innovation,” said Jurgi Camblong, PhD, CEO and co-founder of Sophia Genetics. “With a community of now over 900 teaching hospitals using our technologies, we are in a unique position to connect clinicians and enable them to share knowledge.”
Stanford, LexaGene to Develop Microfluidics-Based Cancer Diagnostic
Stanford University School of Medicine has entered an agreement with LexaGene, a biotechnology company primarily focused on developing a fully automated, open-access pathogen detection platform. With this collaboration, LexaGene will now branch out into cancer diagnostics as well. The partners will incorporate LexaGene’s patented microfluidic system with a targeted cancer sequencing technology developed by Hanlee Ji, MD, who is an associate professor of medicine at Stanford with a focus on oncology. LexaGene’s technology utilizes single-use disposable cartridges to concentrate and purify genetic material from samples and microfluidics to perform molecular analysis. The instrument is also designed so that no pipetting or molecular expertise is required to operate it. “LexaGene’s technology was originally designed for pathogen detection across very large markets—I’m thrilled to report that we are working to expand our technology’s capability to include cancer diagnostics and next-generation sequencing,” said Jack Regan, PhD, LexaGene CEO.