CLN - Industry Playbook

Q BioMed, Mannin Research, McMaster University Team on Glaucoma Test

Industry Playbook: May 2019

Q BioMed and Mannin Research are collaborating with the Biointerfaces Institute at McMaster University in Hamilton, Ontario to develop a point-of-care diagnostic kit for monitoring glaucoma severity and progression. The kit will detect the biomarker growth differentiation factor 15 (GDF-15)—which Q BioMed recently licensed exclusively from Washington University in St. Louis—and will serve as a companion diagnostic to Q BioMed’s MAN-01 small molecule therapeutic for the treatment of primary open-angle glaucoma. As a first step in this project, Mannin Research and the Biointerfaces Institute plan to create, assess, and apply DNA aptamers for detecting GDF-15 in the aqueous humor of patients with different severities of glaucoma. Building on this work, they subsequently expect to develop prototype assays for GDF-15 that will be validated in a clinical setting.

“This diagnostic kit can be used both as a standalone in any ophthalmologist’s office as well as being used as a companion diagnostic with our promising MAN-01 glaucoma therapeutic candidate,” said Denis Corin, CEO of Q BioMed. “Currently, no single examination or diagnostic test is able to accurately predict disease progression, and we believe GDF-15 can help preserve visual function in glaucoma patients through accurate monitoring of disease progression.”

CDC, Group K Diagnostics to Develop Point-of-Care Zika Test

Group K Diagnostics has partnered with the Centers for Disease Control and Prevention (CDC) to design and evaluate a prototype point-of-care (POC) assay for Zika virus RNA that uses reverse transcriptase loop-mediated isothermal amplification (RT-LAMP). The assay will be intended for resource-limited areas where real-time reverse transcription polymerase chain reaction instrumentation is not available. The partners will model the new assay after a test-tube-based RT-LAMP Zika assay developed by CDC and will design it to run on Group K’s microfluidic POC platform, MultiNostic. Group K recently submitted clinical trial data on MultiNostic to the Food and Drug Administration. The company will also bring to the collaboration its experience with meeting logistical demands in resource-limited areas. “The raw materials and scalable manufacturing process we employ enable a very low cost product, making our solution an ideal choice for the CDC research collaboration,” said Brianna Wronko, founder and CEO of Group K.

Broad Institute Opens New Center Focused on Liquid Biopsies

The Broad Institute of the Massachusetts Institute of Technology and Harvard has launched the Gerstner Center for Cancer Diagnostics at the Broad Institute, a new center that aims to develop liquid biopsies and other cancer diagnostics. Specifically, the Gerstner Center’s work will focus on improving the sensitivity of liquid biopsy so that this method can be used to monitor patients’ response to cancer treatment. “Using blood biopsy to track patient response will help us not only determine if a tumor has gotten smaller—something imaging technologies already do—but will help us understand what is happening to the molecular composition of the tumor, something you can’t do with a [computed tomography] scan or [magnetic resonance imaging],” said Viktor Adalsteinsson, PhD, associate director of the Gerstner Center.

The center will also study patients with minimal residual disease in order to develop tests that identify small numbers of cancer cells that remain in patients who have undergone treatment and which may result in future relapse.

Stanford, Lucence Collaborate on Artificial Intelligence for Liver Cancer Diagnosis

The Stanford University School of Medicine has teamed with the Singapore-based firm Lucence Diagnostics to develop artificial intelligence algorithms for improving the diagnosis and treatment of liver cancer. Specifically, the partners will develop diagnostic software tools that incorporate ultrasound, computed tomography, and magnetic resonance imaging results with sequencing data on oncogenic mutations and hepatitis viral DNA. The project will evaluate a dataset of more than 5,000 patients to identify image changes and patterns linked to diagnostic and treatment outcomes in liver cancer. Lucence is the developer of a liquid biopsy next-generation sequencing test that analyzes the DNA of cancer-causing mutations and viruses and will contribute its genomics experience and proprietary sequencing technology to the project. “By combining radiology with our proprietary sequencing technology and track record in liver cancer data modeling, our artificial intelligence algorithms will assist physicians in making better treatment decisions,” said Min-Han Tan, MBBS, PhD, founder and CEO of Lucence Diagnostics.

Ambry Genetics, My Gene Counsel Start DTC Genetic Test Confirmation Service

Ambry Genetics has partnered with the digital health company My Gene Counsel to offer One-Stop Solution, a service that will confirm direct-to-consumer (DTC) genetic test results through medical-grade testing and also provide genetic counseling to consumers. The program is specifically intended for individuals who have a personal or family history of cancer and who have taken a DTC genetic test for cancer risk but have unresolved questions about their results. Ambry based its decision to start this service in part on a study the company published in Genetics in Medicine in 2018. This study examined gene variants reported in the raw data of DTC genetic testing and found a 40% false-positive rate and also that 17% of variants were misinterpreted as high risk. “Our results demonstrate the importance of confirming DTC raw data variants in a clinical laboratory that is experienced in both complex variant detection and classification,” said Brigette Tippin Davis, PhD, senior vice president of research and development at Ambry Genetics. 

Mayo, Advanced Biological Laboratories Partner on CMV Antiviral Resistance Test

Mayo Clinic Laboratories and the Luxembourg-based diagnostics company, Advanced Biological Laboratories, have joined forces to develop a test that will aid in the management of patients infected with human cytomegalovirus (CMV) that is potentially resistant to antiviral drugs. The test detects mutations associated with antiviral resistance in the CMV genes UL54 and UL97using a next-generation sequencing-based polymerase chain reaction method. The test is also coupled with Advanced Biological Laboratories’ software, DeepChek-CMV, which analyzes sequencing data and provides an interpretation of potential drug resistance in cytomegalovirus. “We are extremely proud to support the development of this lab-developed test through the provision of our DeepChek-CMV software and are hoping to make CMV personalized treatment adaptation a reality for these patients suffering from CMV infection,” said Chalom Sayada, MD, PhD, CEO of Advanced Biological Laboratories.