CLN Article

Industry Playbook

BD, Seegene Team on Multiplex Molecular Diagnostics

Seegene and BD Life Sciences have joined forces to co-develop multiplex real-time PCR reagents for BD’s molecular diagnostics platform, the BD Max system. Under the terms of their agreement, Seegene will develop and manufacture multiplex tests based on its novel core enabling technologies (dual priming oligonucleotide, tagging oligonucleotide cleavage and extension, and multiple detection temperatures) that can simultaneously detect multiple targets with high sensitivity, specificity, and reproducibility. These tests will be designed exclusively for the BD Max system, which combines and automates real-time PCR extraction, amplification, and detection into a single platform capable of running a wide range of assays across multiple disease states. BD will have worldwide commercialization rights to these tests.

“Our agreement with BD represents another meaningful milestone to Seegene’s global expansion initiatives in the molecular diagnostics market,” said Seegene CEO Jong-Yoon Chun, PhD. “BD’s commercial strength in the [in vitro diagnostics] market will help to bring Seegene’s powerful multiplex PCR chemistry technologies to more physicians and patients worldwide.”

UConn, JAX to Launch Center for Single Cell Genomics

The University of Connecticut and the Jackson Laboratory for Genomic Medicine (JAX) plan to launch a $7.7 million joint center that will be one of the first in the world dedicated to single cell genomics. Named the Single Cell Genomics Center, it will enable investigators from both UConn and JAX to gain a much more precise view of cellular mechanisms, such as the genetic change within a primary tumor or immune cell response to infection. Working with individual cells has historically posed major technological challenges because a single cell contains far too little biological material for most research methodologies. Consequently, tissues are usually studied in bulk preparations containing mixtures of cells, which potentially masks important differences among the underlying cell types. Recent major advances in automation and microfluidics, however, now enable researchers to effectively analyze single cells in small, well-controlled reaction volumes.

“Single cell genomic technology is rapidly developing,” said Paul D. Robson, PhD, JAX’s director of single cell genomics. “Therefore it is important to have a lab dedicated to remaining on the leading edge of these technologies, to ensure that biologists within the community have the best tools available to make an impact on their science.”

Memorial Sloan Kettering, Illumina Partner on ctDNA Research

Memorial Sloan Kettering Cancer Center (MSK) and Illumina will study circulating tumor DNA (ctDNA) in order to develop new strategies to diagnose and monitor cancer. The two organizations aim to conduct research trials designed to answer biological and clinical questions about ctDNA in multiple cancer types. As part of this plan, MSK will collect samples, and Illumina will use its sequencing technology to detect ctDNA in those samples. The collaboration will then work to validate a ctDNA assay to demonstrate correlation between ctDNA signal and cancer burden. “Is ctDNA not simply equivalent to, but superior to current methods of cancer diagnosis and monitoring? Can we replace expensive and invasive monitoring with a blood test? Does ctDNA reflect the total burden of cancer clones, and is it equivalent to or better than biopsies at predicting outcome and therapeutic response? These are the types of questions we will work towards answering,” said Rick Klausner, MD, senior vice president and chief medical officer of Illumina.

CardioDx Deal With Quest Expands Patient Access to Coronary Artery Disease Test

CardioDx has signed a national specimen-draw agreement with Quest Diagnostics that will expand patient and clinician access to the Corus CAD lab-developed blood test. With a 96% negative-predictive value, this test incorporates age, sex, and gene expression measurements into a single score indicating the likelihood that a patient has obstructive coronary artery disease (CAD), according to the company. Under the terms of the multi-year contract, clinicians will be able to order blood draws on patients for testing through Quest’s approximately 2,200 patient service centers and 4,000 phlebotomists in physician offices in the U.S. Samples will then be forwarded to CardioDx’s CLIA-certified laboratory in Redwood City, California for testing. If used early in the evaluation of symptomatic patients, the Corus CAD test is intended to help clinicians determine whether or not further cardiac testing is necessary, thus helping patients avoid unnecessary imaging and invasive cardiac procedures.

Roche Inks Deal to Acquire Microbiology Diagnostics Firm

Roche has announced plans to buy GeneWeave BioSciences, a microbiology diagnostics company, for an upfront payment of $190 million and up to $235 million in contingent product-related milestones. Once the trans­action closes, GeneWeave will be integrated into Roche Molecular Diagnostics. “With GeneWeave, we further strengthen our microbiology diagnostics offerings with cutting-edge technology that will aid in the fight against drug-resistant bacteria,” said Roland Diggelmann, chief operating officer of Roche Diagnostics. This acquisition provides Roche with GeneWeave’s Smarticles technology, a novel class of molecular diagnostics that quickly identifies multidrug-resistant­ organisms (MDROs) and assesses antibiotic susceptibility directly from clinical samples, without the need for traditional enrichment, culture, or sample preparation processes. GeneWeave’s first system in development is the vivoDx—a fully automated, random-access system designed to meet the needs of laboratories addressing MDRO detection and antibiotic therapy guidance.