CLN Article

Industry Playbook

Biocartis, Microbiome Collaborate on Rapid Sepsis Test

Biocartis and Microbiome, a spin-off of the VU University Medical Center Amsterdam, have joined forces to develop an integrated multiplex real-time PCR assay for rapid detection of bloodstream infections. Under the terms of the license agreement, Microbiome’s multiplex PCR assay for identification of sepsis-causing microorganisms will be further developed for use with a new platform under development by Biocartis, the Idylla-Enrich. Idylla-Enrich is a pre-enrichment platform for bloodstream infections, and has been tested extensively as part of the largest sepsis study in Europe to date, the Molecular Diagnosis and Risk Stratification of Sepsis study, which comprised almost 7,500 clinical samples.

Evidence indicates that a delay in the treatment of a patient with sepsis increases mortality by 7.6% per hour in the first 6 hours after sepsis onset. However, today’s gold standard approach for detecting sepsis-causing pathogens is blood culture, which typically takes 24–48 hours for bacteria and up to 5 days for fungi. By combining Biocartis’s enrichment method with Microbiome’s assay on the Idylla platform, the collaborators aim to identify pathogens in bloodstream infections much faster, reducing current approaches of 24–48 hours to as little as 2 hours.

BCBS, U of Michigan Health System Partner to Evaluate and Improve Genetic Testing

Blue Cross Blue Shield of Michigan (BCBS) and the University of Michigan Health System are collaborating with physicians and laboratories across the state as part of a new initiative to improve genetic testing practices. Called the Genetic Testing Resource and Quality Consortium, this initiative will help medical professionals determine whether genetic testing should be used in common clinical scenarios, and which tests will benefit patients the most. Participants also will develop best practices for performing the tests, improving testing quality, and advising patients on genetic testing recommendations. Currently, BCBS and the University of Michigan Health System are in the process of recruiting participants. Once this phase is complete, the collaborators will start reviewing medical literature, clinical protocols, and patient data to determine which genetic tests are the most effective.

“This initiative will develop evidence-based guidelines to help physicians and their patients make important decisions about whether or not to get tested and, when testing is indicated, which tests will best meet their health needs and goals,” said David Share, MD, senior vice president of value partnerships at BCBS.

Roche Buys Genomics Research Company Developing Liquid Biopsy Technology

Roche has acquired CAPP Medical, a genomics research company founded by Stanford University oncologists and in vitro diagnostic industry veterans, to advance technologies to detect circulating tumor DNA (ctDNA) in blood. CAPP Medical’s next-generation sequencing–based technology is designed to isolate and quantify small amounts of ctDNA in blood samples and enables the detection of multiple mutations in a single assay. Currently, this technology is for research use only, but potentially could be used for cancer therapy selection and monitoring tumor response and resistance to therapy.

“Roche believes focused and high quality next-generation sequencing assays using simple blood draws have the potential to significantly advance the time of cancer diagnosis and change routine cancer diagnostic monitoring, and may be highly cost effective compared to today’s current standard of using PET and CT imaging to monitor tumor progression,” said Roland Diggelmann, chief operating officer of Roche Diagnostics.

Janssen, Royal Philips to Develop POC Test for Neuropsychiatric Disorders Royal Philips and Janssen Pharmaceutica have inked a multi-year agreement to develop a new handheld blood test that could provide doctors with a novel tool to improve the care of patients with neuropsychiatric disorders. The partnership unites Philips’s know-how in point-of-care testing and monitoring applications for the hospital and home with Janssen’s experience in designing solutions to treat brain disorders. The blood test will be based on Philips’s Minicare I-20 system for immunoassays, which is currently under development and consists of a handheld analyzer, dedicated software, and a single use, disposable cartridge containing the application specific test. Based on Philips’s proprietary biosensor technology, the Minicare I-20 system is being developed to detect multiple target molecules at low concentrations within the same blood sample and to show the results on the analyzer display within minutes. Janssen will be responsible for the clinical studies to validate the test, as well as commercialization of the final product.

Partnership to Investigate a New Method for Monitoring Multiple Myeloma

The Multiple Myeloma Research Foundation (MMRF), University of Torino, Italy, and Adaptive Biotechnologies have formed a partnership to perform a sequencing-based assessment of minimal residual disease (MRD) on hundreds of multiple myeloma patients over a 5-year period. The purpose of this initiative, which is also partially supported by Amgen, is to investigate a new approach to monitoring MRD. It will be part of the larger Inside MM-1 study, a comparative, clinical disease monitoring trial led by the University of Torino. More than 400 newly diagnosed multiple myeloma patients will be enrolled in Inside MM-1 and will receive a combination of the cancer therapeutics carfilzomib and lenalidomide, followed by a bone marrow transplant with or without maintenance. Patients will then be monitored for MRD using both flow cytometry and Adaptive Biotechnologies’ clonoSEQ MRD test at regular intervals from initial diagnosis for up to 5 years after the start of treatment.

“The intention of Inside MM-1 is to rapidly and systematically assess the accuracy and reliability of sequence-based measurements of MRD compared to the most advanced flow cytometry methodology in a structured manner,” said Antonio Palumbo, MD, a professor at University of Torino and head of the Inside MM-1 study. “Improving the detection of disease response to the best available therapies with the right technologies and as early as possible in treatment can help lead to the most profound and durable responses for our patients.”

UC Davis, Foundation Medicine Team on Personalized Oncology Initiative

The University of California, Davis (UC Davis) Comprehensive Cancer Center and department of pathology and laboratory medicine have entered a collaboration with Foundation Medicine. This partnership aims to leverage Foundation Medicine’s molecular information service to make comprehensive genomic profiling the standard of care at UC Davis, enabling physicians to prescribe targeted cancer treatments to patients based on the genetic makeup of each individual’s cancer. Foundation Medicine uses comprehensive genomic profiling to analyze clinical specimens and detect relevant alterations in hundreds of cancer-related genes. The company then combines the genomic data with the latest scientific and medical information, including targeted therapeutic agents and open clinical trials, to determine potential treatment options for each patient. In exchange for this service, UC Davis will also contribute outcomes data generated from these efforts that Foundation Medicine will incorporate into its molecular information knowledgebase, FoundationCore. The parties expect this will provide the broader oncology and pathology communities with information to help inform treatment decisions for other patients.