PATH, a Seattle-based global health nonprofit, is partnering with the U.K. firm Mologic to advance a new rapid diagnostic test (RDT) to support treatment and elimination of malaria caused by Plasmodium vivax (P. vivax). P. vivax is especially difficult to eliminate because the parasite can lie dormant in the liver and re-emerge, causing relapsing periods of illness. Treatment with 8-aminoquinolines, a class of drugs that includes primaquine, is currently the only means to kill the liver form of the P. vivax parasite. However, 8-aminoquinolines can cause serious side effects in patients with severe glucose-6-phosphate dehydrogenase (G6PD) deficiency, a hereditary condition common to areas where malaria is found. The World Health Organization recommends testing patients for G6PD deficiency before administering treatment with primaquine, but the diagnostic tests currently on the market for G6PD deficiency are not robust nor simple enough for widespread use in the hot, humid, and low-resource areas where malaria is endemic.

PATH is therefore advancing a portfolio of tests for G6PD deficiency that meet requirements for use in settings where P. vivax malaria is close to elimination. As part of this effort, PATH is working with Mologic to develop a novel qualitative point-of-care G6PD RDT. PATH and Mologic optimized the Mologic RDT for use in environmental conditions typical in malaria-endemic countries and for use in communities where malaria is commonly diagnosed and treated. The test also provides simple results (positive or negative) that test users can easily interpret to determine if a patient has severe G6PD deficiency.

“[This test] will help to fill critical gaps in G6PD testing experienced by elimination programs, and will complement quantitative tests for G6PD deficiency being advanced by PATH and partners,” said Gonzalo Domingo, PhD, scientific director and malaria diagnostics lead at PATH.

BioMérieux Buys Astute Medical

BioMérieux has acquired Astute Medical, the manufacturer of the NephroCheck test, which is a Food and Drug Administration-cleared diagnostic for the early risk assessment of acute kidney injury based on the level of two biomarkers, insulin-like growth factor-binding protein-7 and tissue inhibitor metalloproteinases-2. This acquisition builds upon a partnership between the two companies developed in 2015 when Astute granted bioMérieux a license to develop and market the NephroCheck test for the Vidas automated immunoassay system. Following this, bioMérieux has been a licensed distributor with Astute since 2017 for the NephroCheck test on the Astute140 Meter in the U.S. With this acquisition, bioMérieux now intends to continue to invest in health economic and outcome studies for NephroCheck, explore the other promising biomarkers in the Astute pipeline, and work with Astute’s current license and distribution partners in order to expand patient access to the NephroCheck test worldwide.

Illumina, Bristol-Myers Squibb Team on Immunotherapy Co-Diagnostics

Illumina and Bristol-Myers Squibb have partnered to use Illumina’s next-generation sequencing (NGS) technology to develop and globally commercialize in vitro diagnostic assays in support of Bristol-Myers Squibb’s oncology portfolio. Bristol-Myers Squibb’s clinical development program includes 24 clinical-stage molecules designed to target different immune system pathways across more than 50 types of cancers, and through its translational capabilities, the company has identified a number of potentially predictive biomarkers for these oncology therapeutics, including programmed death-ligand 1, tumor mutation burden, microsatellite instability-high or mismatch repair deficient, and lymphocyte-activation gene 3. The companies will develop a diagnostic version of the Illumina TruSight Oncology 500 assay to measure these biomarkers. “With [Bristol-Myers Squibb’s] leading position in immunotherapy development, we see tremendous promise in this partnership to co-develop next-generation sequencing-based diagnostics that can identify effective therapeutic combinations and provide global access to these targeted drugs,” said Garret Hampton, PhD, executive vice president of clinical genomics at Illumina.

PerkinElmer, Helix Join Forces on Direct-to-Consumer Tests for Genetic Conditions

PerkinElmer is collaborating with Helix, a personal genomics company, to develop and commercialize exome sequencing-based tests that will be made available to consumers through Helix’s online marketplace for DNA-powered products. The initial targeted product offering will return results for 59 genes that the American College of Medical Genetics and Genomics identifies as highly penetrant genetic conditions with established interventions aimed at significantly reducing morbidity and mortality. A clinician will review all orders placed for these products through the Helix store to ensure that the test is medically appropriate before the order is completed. All DNA sequencing data for these products will then be generated using Helix’s proprietary Exome+ assay in its CLIA- and College of American Pathologists-certified next-generation sequencing laboratory. In turn, PerkinElmer Genomics’ medical genetics team will provide data analysis and interpretative services to individuals who purchase the product. Upon request, genetic counseling will also be available free of charge to people using PerkinElmer Genomics products on the Helix platform.

RTI International to Support PierianDx’s Clinical Genomics Initiatives

The research institute RTI International has joined forces with PierianDx with the aim of solving the problem of translating complex genomic data into actionable clinical information. The collaboration will include investment and other strategic support to help advance PierianDx’s growth plan. Since 2014, PierianDx has focused on providing solutions to accelerate molecular testing and advance precision medicine. The company has built the Clinical Genomics WorkSpace (CGW), a comprehensive clinical genomics platform that creates streamlined, accurate analysis, interpretations, and reporting for clinical labs. By integrating cloud-based software and clinical lab enablement services, the CGW helps to simplify the process of translating genomic data into patient-specific diagnosis and treatments. PierianDx also founded the PierianDx Partner Sharing Network, which has more than 50 members—including leading academic medical centers, cancer centers, and health systems—that use shared genomic data to personalize treatments for cancers and hereditary diseases.

MIODx, DiaCarta to Develop Test to Guide Immunotherapy

MIODx, an early-stage immunogenomics company, has partnered with DiaCarta, a translational genomics and personalized diagnostics company based in the U.S. with significant business operations in China. The two firms plan to develop a diagnostic test to predict patient response to immunotherapy. They will base the test on MIODx’s ClonoMap immune sequencing platform, which is designed for the development of diagnostics and immunotherapies, and to interrogate a person’s immune system. The new test will be developed and validated at DiaCarta’s CLIA labs in both the San Francisco Bay Area and Nanjing, China, followed by manufacturing at DiaCarta’s ISO 13485-certified GMP-compliant manufacturing facility. “With the well-established CLIA and ISO manufacturing facility at DiaCarta, also the experienced [in vitro diagnostics] team and sales channels in the U.S., Europe, and China, we are able to speed up our MIODx’s ClonoMap technology to the global market, especially the huge market potential in China,” said M. Allen Northrup, PhD, CEO of MIODx.