Policy & Regulation
Fusion Genomics Receives USD 1m Award to Evaluate Novel Genomic Diagnostics Platform in Collaboration with Sunnybrook Research Institute
13 January 2020 - - Canada-based Fusion Genomics has been awarded USD 1m to conduct a prospective clinical study evaluating its ONETest comprehensive, novel genomic diagnostics platform, the company said.

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.

US Merck (NYSE: MRK) 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 -based assay for infectious disease diagnosis, to identify pathogens responsible for respiratory tract infections in a hospital setting.

These infections are a leading cause of morbidity, mortality and hospitalisations globally, due in part to limitations associated with current diagnostic tests.

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.

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.

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 -based tests have the potential to disrupt the USD 8bn global infectious disease diagnostics market, replacing many conventional and molecular clinical lab tests.


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