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 said. ¡°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.
