EKF Molecular Diagnostics, Angle Partner on Liquid Biopsy for Colon, Other Cancers

EKF Molecular Diagnostics has entered a collaboration with the specialist medtech company Angle to develop a liquid biopsy combining Angle’s Parsortix circulating tumor cell (CTC) harvesting platform with EKF’s PointMan DNA enrichment technology. The collaboration will initially focus on colorectal cancer before expanding to other cancer types, and will start by harvesting CTCs from cancer patients’ blood using Angle’s Parsortix system. These CTCs will then be analyzed using PointMan DNA enrichment technology to identify genetic variation in the cancer.

The PointMan system preferentially amplifies variant sequences of interest while suppressing amplification of wild type DNA, giving it the potential to identify all mutations associated with the clinical utility of targeted cancer therapies. Both EKF and Angle believe this may give PointMan an advantage over existing genetic analysis systems, which generally only amplify those areas predicted to contain a mutation, potentially missing unexpected variants. The PointMan system also works with levels of target material potentially as low as one CTC, while the Parsortix system harvests rare CTCs in cancer patient blood even when there is less than one CTC in one billion healthy cells. These capabilities could enable the combined Parsortix-PointMan system to be used in the diagnosis of a wide variety of cancer types and stages of disease.

Through Angle’s existing research collaboration with the University of Surrey and the Royal Surrey County Hospital, the University of Surrey Oncology Department has already processed 20 colorectal cancer patient samples with the Parsortix system and stored the harvested cells for analysis. This bank of samples should enable the collaboration to make rapid progress toward initial proof-of-principle.

Ortho Inks Agreement to Distribute Transfusion Diagnostics Platform

Ortho-Clinical Diagnostics has entered an agreement with commercial-stage diagnostics company Quotient Limited to distribute and sell Quotient’s transfusion diagnostics platform MosaiQ. MosaiQ, which is currently in development, is being designed with Quotient’s proprietary technology platform with the aim of providing improved time to results and more comprehensive matching of donor and patient blood.

Under the terms of the agreement, Quotient is responsible for developing and launching MosaiQ, while Ortho will have exclusive rights to distribute MosaiQ to the global patient testing market for blood grouping, and to the donor testing market in the developing world and Japan for blood grouping and serological disease screening.

T2 Biosystems, Canon Collaborate on Lyme Disease Test

T2 Biosystems and Canon U.S. Life Sciences have formed a strategic agreement to develop a novel diagnostic test panel for the rapid detection of Lyme disease. The current gold standard for Lyme disease diagnosis is blood culture, but this technique has low sensitivity and takes approximately 2 to 3 weeks to provide results. The Centers for Disease Control and Prevention estimates that Lyme disease affects close to 360,000 people in the U.S. each year, but that only 30,000 of these cases are reported due to poor diagnostic testing. This partnership hopes to leverage the T2 Biosystems T2MR technology platform—which uses magnetic resonance to detect molecular and immunodiagnostic targets—to develop an accurate test that can provide results within hours. Under the terms of the agreement, T2 Biosystems will receive an upfront payment of $2 million from Canon U.S. Life Sciences, and additional milestone payments that will add up to $8.5 million.

WaferGen, U Toronto to Develop Test for Population-Wide BRCA1, BRCA2 Screening

WaferGen Biosystems has formed a research partnership with the Familial Breast Cancer Research Unit of the Women’s College Research Institute at the University of Toronto to develop a cheaper test for BRCA-related cancer. With a focus on breast and ovarian cancers, the Familial Breast Cancer Research Unit studies genetic mutations that are known to increase the risk of many cancers, most notably the BRCA1 and BRCA2 mutations. The collaboration will use WaferGen’s Seq-Ready TE System—a one-step target enrichment and library preparation solution—with the goal of enabling affordable, large-scale BRCA1 and BRCA2 screening for the general population. The research conducted around the collaboration will be led by Steven Narod, MD, director of the Familial Breast Cancer Research Unit and co-discoverer of the BRCA1 and BRCA2 genes.

“We believe that there is a significant medical benefit to providing BRCA1 and BRCA2 genetic testing for the general population,” said Narod. “However, in order to offer large-scale genetic screening, an accurate, low-cost test will need to be developed. Based on our experience, we think WaferGen’s Seq-Ready TE System has the potential to enable the development of such a test.”

Roche Buys Company Specializing in Cancer Biobanks, Next-Generation Sequencing

Roche has acquired Signature Diagnostics, a translational oncology and genomics company that develops large blood plasma and tissue biobanks in multiple cancers—including colorectal and lung—from multicenter prospective clinical studies. Signature uses the samples from its biobanks along with accompanying clinical progression and genetic data to develop and validate next-generation sequencing (NGS)–based cell-free DNA tests for non-invasive monitoring of treatment response for cancer patients. “Biobanks play an important role in uncovering the cause or origin of disease such as cancer, which is important in translational research and the development of personalized therapies for patients,” said Roland Diggelmann, chief operating officer of Roche Diagnostics. “Signature represents a unique bridge between high value cancer biobanks and NGS assay development. Roche plans to leverage Signature’s expertise in both of these areas to accelerate the development of targeted NGS-based diagnostics in the future.”

Baylor College of Medicine, Miraca to Start New Clinical Genetics Lab

Under the terms of a new partnership, Baylor College of Medicine in Houston, Texas plans to share ownership and governance of its clinical genetics diagnostic laboratories with Miraca Holdings. Baylor is home to one of three U.S.-based large-scale genome sequencing centers funded by the National Institutes of Health, and Miraca is a Japan-based international healthcare company with a focus on clinical laboratory testing. Together, the two plan to start Baylor Miraca Genetics Laboratories, a jointly-owned clinical diagnostic venture that will be headquartered in Houston. The new laboratories will be built on Baylor’s existing Medical Genetics Laboratories. “Academic medical centers and teaching hospitals in Houston have lagged behind other areas of the country in commercializing medical inventions developed in their laboratories,” said Paul Klotman, MD, president, CEO, and executive dean of Baylor. “With partnerships such as this, the potential for growing biotech into a major economic driver for Houston and the Texas Medical Center is tremendous.”