CLN Article

Industry Playbook

Philips, Banyan Biomarkers Team on POC Test to Diagnose Concussions

Royal Philips and Banyan Biomarkers have joined forces to develop and commercialize a new handheld blood test to detect and evaluate concussions—also known as mild traumatic brain injury—at the point of care. The partnership will leverage Banyan’s knowledge of biomolecules that indicate neurological injuries, as well as Philips’ patient monitoring and handheld diagnostics technologies.

Diagnosing concussions is difficult due to the fact that a CT scan of the patient’s brain often looks normal despite the patient having a significant injury. Currently, there is no blood test that detects the presence and severity of brain trauma such as concussion. Philips and Banyan aim to change this now that Banyan has identified two proteins that appear rapidly in the blood of patients soon after incurring a brain injury.

“A rapid and objective point-of-care test to evaluate traumatic brain injury will help millions of patients throughout the world,” said Jackson Streeter, MD, CEO of Banyan Biomarkers. “This partnership … is an important step forward in providing physicians and other healthcare providers information to evaluate patients who have suffered a concussion.”

The new handheld test will be based on Philips’ Minicare I-20 system, which consists of a handheld analyzer, dedicated software, and a single use, disposable cartridge containing the application-specific test. It will use Philips’ proprietary Magnotech biosensor technology to detect multiple target molecules at low concentrations from a blood sample and to show the results on the analyzer display within minutes.

Bio-Rad, Illumina to Develop NGS Solution for Single-Cell Analysis

Bio-Rad Laboratories and Illumina have entered an exclusive partnership to develop a comprehensive next-generation sequencing (NGS) workflow that will enable high-throughput sequencing of thousands of individual cells. Most scientific studies rely on analysis of bulk tissue samples, which are usually composed of multiple cell types with varying functions. Gene expression data is then averaged across cells, making it difficult to identify differences between cells and to understand the role of cell variation. Single-cell sequencing could help to solve these challenges and provide deeper insight into cell function, disease progression, and therapeutic response.

Using Bio-Rad’s droplet partitioning technology and Illumina’s NGS technologies, the companies’ new solution will isolate and barcode single cells for downstream sequencing. Data analysis will then be conducted via BaseSpace, Illumina’s cloud-based genomics computing environment. According to a press release by both companies, the solution will be scalable to isolate significantly larger numbers of single cells compared to commercially available solutions today.

bioMérieux Buys Firm Specializing in Bioscience Software Solutions

BioMérieux has acquired Applied Maths, a company that develops software solutions for the biosciences, specifically for databasing, analyzing, and interpreting complex biological data. With the transaction finalized, bioMérieux plans to leverage Applied Maths’ BioNumerics universal software. The latter is designed for microbiology applications—including bacteriology, virology, and mycology—and can manage a wide range of different data types, from phenotypic information and molecular PCR to spectral profiles.

Initially, the acquisition of Applied Maths will expand the bioMérieux EpiSeq service in next-generation sequencing for the epidemiological monitoring and control of healthcare-associated infections. Taking a longer-term perspective, bioMérieux also foresees synergies in the field of clinical microbiology, particularly in optimizing bioMérieux’s data management tools and collecting clinically-relevant bacterial strains, as well as consolidating data from different instruments such as the recently-acquired FilmArray.

Swift Biosciences, SeraCare to Develop ctDNA Reference Standards for Liquid Biopsies

Swift Biosciences and SeraCare Life Sciences are collaborating to accelerate the development of a novel circulating tumor DNA (ctDNA) reference material that could be used to develop and monitor performance of liquid biopsies for cancer. Seraseq ctDNA products are based on patent-pending technology that is used to make circulating fetal DNA reference materials. They contain mixtures of DNA with key somatic mutations at specific allelic frequencies and are provided as stabilized material in a proprietary synthetic plasma matrix. These reference materials are also highly customizable and can support any number of mutations and allele frequencies as quantitated by digital PCR. “Understanding and characterizing any next-generation sequencing assay for liquid biopsy samples will require well-defined reference reagents,” said Timothy Harkins, PhD, CEO of Swift Biosciences. “Standards like Seraseq ctDNA reference material allow the community to first understand ctDNA properties, optimize assays, and then ultimately use ctDNA in innovative assays to detect and monitor cancer burdens within samples.”

The first ctDNA reference material available for early access is a 9-mutation mixture at varying allele frequencies targeted from 5% down to 0.1%.

Thermo Fisher Inks Deal to Acquire Affymetrix

For approximately $1.3 billion, Thermo Fisher Scientific plans to buy Affymetrix, a company specializing in technologies that enable parallel and multiplex analysis of biological systems at the cellular, protein, and genetic levels. This acquisition will significantly expand Thermo Fisher’s antibody portfolio and its offerings in the flow cytometry market. In genetic analysis, Affymetrix will add complementary products to Thermo Fisher’s portfolio for cytogenetics, genotyping, and gene expression. Additionally, Thermo Fisher believes Affymetrix’s microarray platform will strengthen Thermo’s presence in certain clinical and applied markets such as reproductive health. In turn, Affymetrix expects to benefit from Thermo Fisher’s access to the biopharma industry, as well as its market presence and infrastructure in the Asia-Pacific region, particularly in China. The transaction is expected to be completed by the end of the second quarter of 2016, and is subject to the approval of Affymetrix’s shareholders.

Pfizer, KineMed Collaborate on Kinetic Biomarker Search

Pfizer and KineMed have teamed to discover and develop novel biomarkers in various fields of unmet clinical need. By utilizing mass spectroscopy and stable isotope labeling of protein turnover, KineMed’s platform technology provides rates of change for key proteins involved with therapeutic efficacy and target engagement. Under the terms of the agreement, Pfizer will be granted licensed access to the KineMed platform along with rights to pursue discovery, development, and potential commercialization of kinetic biomarkers and any resulting companion diagnostics in various fields. In turn, KineMed will receive an upfront payment, as well as funding for research and development costs associated with Pfizer-selected targets. “We believe our kinetic biomarker platform provides real advantages over other approaches to biomarker discovery in de-risking and advancing medicines development, and this collaboration with Pfizer is an important step toward helping us realize the full potential of this technology,” said Patrick Doyle, PhD, president of KineMed.