The assay is currently being developed as a qualitative in vitro diagnostic to detect sequence variations in key genes related to homologous recombination deficiency (HRD) for single nucleotide variants, indels, and copy number variants.

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.

“This Breakthrough Device Designation from the FDA is an important step forward for the company,” said Mark Li, CEO of Resolution Bioscience. “For many patients, tissue biopsies are not possible or do not yield evaluable samples. We hope that our fast, accurate, and non-invasive technologies may offer additional options for patients and also help our pharmaceutical partners accelerate their development efforts.”

The goal of the FDA Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment, and review. The program focuses on devices that have novel technologies that have the potential to provide more effective diagnosis of life-threatening conditions such as cancer.

About Resolution Bioscience’s Technology

The Resolution HRD assay is powered by the company’s patented cfDNA NGS analysis platform, which includes proprietary targeted capture NGS chemistry and tightly-coupled cloud-based bioinformatics. Resolution’s liquid biopsy technology has now been cited in several important research publications and presentations. For example:

The company was the first to demonstrate detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.

Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.

Resolution recently published 97% clinical response data with Memorial Sloan Kettering Cancer Center for non-small cell lung cancer patients who received plasma-directed therapy selection from Resolution’s assay. With more than 950 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.

In a recent AstraZeneca publication, Resolution had the highest positive predictive value (PPV) and lowest false positive rate amongst four leading NGS liquid biopsy companies in a blinded comparison study.

In another recent study presented at the 2019 American Association of Cancer Research Annual Meeting, researchers at the Dana-Farber Cancer Institute used Resolution technology to detect nearly twice as many gene fusion mutations with significantly higher allele frequencies than the Guardant360 test.

Source: Company Press Release