Resolution Bioscience is the latest in a long line of firms that has been granted breakthrough device designation from FDA. The Kirkland, WA-based company received the designation for its qualitative in vitro diagnostic.
Known as the Resolution HRD, the company’s liquid biopsy test promises to detect sequence variations in key genes related to homologous recombination deficiency (HRD) for single nucleotide variants, indels, and copy number variants.
“This designation is really helpful because it allows us to have more frequent and less formal interactions with more senior people at FDA,” Mark Li, Resolution Bioscience CEO, told MD+DI. “This will expedite our development, review, and hopeful approval of the assay.”
Resolution Bioscience plans to seek approval for the Resolution HRD assay as a companion diagnostic. If approved, the Resolution HRD assay could be the first assay to detect gene deletions from cell-free DNA (cfDNA) and differentiate between single copy and biallelic (homozygous) gene deletions through a simple blood draw.
The assay would also detect biallelic loss of function through a combination of a deleterious mutation and a heterozygous deletion in the same gene.
“We’ve been working on this particular assay for three years now,” Li said. “[The assay is focused] on detecting gene deletions from blood. What most of the liquid biopsy field is struggling to do is copy number amplifications. Gene deletion is a much subtler mutation to detect. We’re basically trying to detect the absence of a signal in a highly noisy background.”
With the liquid biopsy space booming the competition can get pretty fierce. Data will be key in evaluating the effectiveness of the liquid biopsy offerings.
Recently researchers from Diana-Faber Cancer Institute presented data at the 2019 American Association of Cancer Research Annual Meeting from a study that compared Resolution Bioscience’s technology to Guardant Health’s Guardant360 test.
Results revealed that Resolution Bioscience’s assay was able to detect nearly twice as many gene fusion mutations with significantly higher allele frequencies than the Guardant360 test.