In collaboration with Janssen Research & Development, Resolution Bioscience is developing the Resolution HRD liquid biopsy assay as a companion diagnostic for the Janssen therapeutic niraparib, a poly ADP ribose polymerase inhibitor that is designed to treat metastatic castration-resistant prostate cancer. This assay recently received Breakthrough Device Designation from the Food and Drug Administration, and Janssen is currently using it to identify prostate cancer patients with homologous recombination deficiency (HRD) mutations and gene deletions in phase II and III clinical studies of niraparib.

The Resolution HRD liquid biopsy assay detects HRD mutations and gene deletions in cell-free DNA (cfDNA) and distinguishes between single copy and biallelic gene deletions. It also detects homozygous deletions and identifies when deleterious mutations and heterozygous deletions are present in the same gene, a combination that causes biallelic loss of function. If approved as a companion diagnostic for niraparib, the Resolution HRD assay could become the first commercial test to detect all these alterations from a blood draw.

“Built on our proprietary cfDNA next-generation sequencing technology platform, we expect the Resolution HRD assay will enable Janssen to identify patients with prostate cancer who may benefit from niraparib therapy," said Mark Li, CEO of Resolution Bioscience. Due to the assay’s noninvasive approach, Resolution Bioscience believes that it could also help expand patient access to other targeted prostate cancer therapies.

FIND, Unitaid to Study Use of NGS for Diagnosis of Drug-Resistant TB

The Foundation for Innovative New Diagnostics (FIND) and Unitaid have launched the Seq&Treat program to evaluate the use of next-generation sequencing (NGS) for diagnosis of drug-resistant tuberculosis (TB) in low- and middle-income countries (LMICs). In October 2019, the partners will begin to implement this program across Brazil, China, Georgia, India, and South Africa. The project’s goals include generating clinical evidence to support World Health Organization global guidance for the use of targeted NGS for drug-resistant TB diagnosis; evaluating proof-of-principle delivery models for integrating targeted NGS into existing diagnostic workflows; and facilitating the inclusion of recommended NGS solutions into global procurement mechanisms for LMICs.

“The implementation of sequencing for patient care in LMICs has been limited due to perceptions of high cost, technical and workflow complexity, and lack of infrastructure on both supply and demand sides,” said Catharina Boehme, CEO of FIND. “This significant investment from Unitaid will enable us to challenge these ideas by demonstrating sustainable and scalable sequencing models in high-burden TB countries.”

Caris Life Sciences, Debiopharm to Develop Assay for Detection of Rare FGFR Fusions

Caris Life Sciences has teamed up with Debiopharm International to develop a companion diagnostic test that will identify patients eligible for Debiopharm’s phase II clinical trial of Debio 1347. Debio 1347 is a selective fibroblast growth factor receptor (FGFR) inhibitor that is designed to treat patients with non-central nervous system solid tumors. The companion diagnostic for this drug will use Caris’ Molecular Intelligence Transcriptome, a new whole transcriptome sequencing assay that detects rare FGFR fusion events that signal the presence of such tumors. This test is RNA-based, which means that unlike DNA-based methods, it detects any fusion event independent of breakpoint locations and fusion partners.

“This collaboration represents a key milestone in the advancement of a new tumor-agnostic approach,” said Angela Zubel, chief development officer at Debiopharm International. “We believe that a whole transcriptome assay is particularly relevant to detect oncogene fusions and to identify tumor expression profiles that could benefit from Debio 1347 therapy.”

Beckman Coulter Life Sciences Acquires Cytobank

Beckman Coulter Life Sciences recently bought Cytobank, a company that provides scientists
with a cloud-based single-cell data analysis platform optimized for high-parameter workflows. The platform enables users to visualize and analyze several single-cell datasets simultaneously, thereby accelerating high-dimensional mass and flow cytometry data analysis. This platform complements Beckman Coulter’s CytoFLEX LX flow cytometer, which is the newest version of the CytoFLEX Platform and features six lasers and 21 color parameters.

Beckman Coulter hopes that their acquisition of Cytobank will meet the growing need for high-complexity workflow and data analysis. “We are excited to add Cytobank’s innovative software solutions and customer workflow-focused team to our flow cytometry business,” said Mario Koksch, MD, PhD, the Flow Cytometry Business Unit vice president and general manager at Beckman Coulter. “We can now provide more standardized, yet flexible high-end data analytics solutions to pharma/biopharma and leading academic clinical research customers.”

Tabula Rasa, CQuentia Aim to Improve Delivery of PGx Results

Tabula Rasa HealthCare (TRHC) and CQuentia are collaborating to offer pharmacogenomics (PGx) services to patients and providers. TRHC is a healthcare technology company that provides solutions to mitigate medication risk, while CQuentia’s services include a clinical genomics testing lab and a personalized medicine analytics platform. Under the terms of their agreement, CQuentia will use TRHC’s MedWise platform to deliver pharmacogenomics results to ordering physicians. To facilitate this, TRHC will establish application programming interfaces with CQuentia to receive PGx data directly from CQuentia’s lab.

“Unlike traditional drug-gene pair analysis, which marginalizes the potential impact of PGx, MedWise uses PGx data to inform precision across a patient’s entire medication regimen,” said Alan Meeker, CQuentia’s CEO. “CQuentia has determined that TRHC’s unique and valuable approach to incorporating PGx lab data into medication safety analysis makes TRHC the ideal partner to present PGx lab results to its clients.”

Invitae Buys Jungla to Advance Its Genetic Variant Interpretation Services

Medical genetics firm Invitae has signed an agreement to acquire Jungla, the developer of a cloud-based platform designed to help clinicians and patients understand the results of genetic and genomic tests. Called the Functional Modeling Platform (FMP), Jungla’s technology combines clinical knowledge with advances in functional genomics, biophysics, cellular engineering, machine learning, and distributed systems. In a November 2018 pilot study, Invitae and Jungla evaluated FMP’s performance when predicting the clinical relevance of DNA variants found in individuals undergoing testing for hereditary disease. The study found that support from Jungla’s FMP helped Invitae to clarify the interpretation of variants and move them from the uncertain category to pathogenic or benign status. Invitae therefore expects this acquisition to enhance its ability to interpret genetic variants and to deliver more affordable genetic testing for use in mainstream medical care.