VANCOUVER, British Columbia–(BUSINESS WIRE)–Fusion Genomics announced today that the company has been awarded $1 million to conduct a prospective clinical study evaluating its ONETest™ comprehensive, novel genomic diagnostics platform. The study is funded through the CQDM Quantum Leap program, which supports exploration of innovative technologies, tools, and platforms that accelerate or facilitate drug discovery and development. Merck is supporting the study as a member of CQDM, and Fusion Genomics will collaborate with Sunnybrook Research Institute to conduct the study.
The one-year project will evaluate the ability of ONETest, a highly sensitive, cost-effective next-generating sequencing (NGS)-based assay for infectious disease diagnosis, to identify pathogens responsible for respiratory tract infections (RTI) in a hospital setting. These infections are a leading cause of morbidity, mortality and hospitalizations globally, due in part to limitations associated with current diagnostic tests.
“We are honored that CQDM has selected the ONETest RTI study as part of its prestigious portfolio of funded programs,” said Mohammad Qadir, president and chief scientific officer of Fusion Genomics. “This study offers Fusion Genomics and our exceptional collaborators the opportunity to begin transforming the diagnosis of RTIs, and thereby reduce the tremendous burden of these infections on both patients and the hospitals that treat them.”
The ONETest PathoGenome is a genomics-based diagnostic assay that simultaneously detects the full spectrum of approximately 1,400 known human infections in a single test. The assay can identify emerging, novel strains to eliminate diagnostic failures associated with the constantly evolving genomes of pathogens, and works on all common sample types.
For the CQDM project, researchers at Fusion Genomics and Sunnybrook Health Sciences Centre will use an RTI-specific version of the ONETest assay, ONETest RTI, to interrogate samples from approximately 800 patients diagnosed with RTI, and then compare results to conventional testing methods. Researchers will also evaluate samples from healthy individuals to help differentiate clinically relevant respiratory pathogens from those that are benign.
“I’m grateful for the investment from CQDM and pleased to be partnering with Fusion Genomics on evaluating this new tool. If we are to do better by our patients, then we need to develop technologies that can identify quickly and with more confidence the root causes of RTIs,” said Dr. Samira Mubareka, a microbiologist at Sunnybrook and scientist at Sunnybrook Research Institute.
“CQDM is pleased to support this project, because we believe it will provide valuable insights to help reduce the morbidity and cost associated with RTIs,” said Diane Gosselin, president and CEO, CQDM. “In addition, this study will be the first of its kind to test a targeted NGS assay with broad coverage of upper respiratory pathogens in a hospital setting during an outbreak season.”
Fusion Genomics is currently evaluating a next-generation assay, the ONETest RAPID, for use on the ONETest platform. This assay utilizes an enhanced version of the same patent-pending QuantumProbes technology that drives the ONETest PathoGenome, to provide direct sample-to-DNA-sequencing in under four hours. The ONETest RAPID is expected to be the world’s first comprehensive and rapid genomic assay for infectious disease.
About Fusion Genomics
Fusion Genomics is a molecular diagnostics company focused on transforming infectious disease through advanced genomic technologies. Fusion is applying novel DNA/RNA capture and informatics technologies to overcome the limitations of current infectious-disease diagnostic tests, with the aim of preventing unnecessary deaths from infectious disease and halting the growing problem of drug resistance. The company’s rapid, highly sensitive, and cost-effective next generation sequencing (NGS)-based tests have the potential to disrupt the
$8 billion global infectious disease diagnostics market, replacing many conventional and molecular clinical lab tests. For more information, visit www.fusiongenomics.com.