Resolution Liquid Biopsy Assay Receives Breakthrough Device Designation from FDA

Accelerated pathway for companion diagnostic development granted to
cell-free DNA assay for detecting HRD mutations and gene deletions

KIRKLAND, Wash.–(BUSINESS WIRE)–Resolution
Bioscience, Inc., today announced that the Resolution HRD™ liquid
biopsy assay has been granted Breakthrough Device Designation by the US
Food and Drug Administration (FDA). 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. For more information on the program, please visit https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program.

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.

About Resolution Bioscience

Resolution Bioscience is a privately held company dedicated to
developing a non-invasive liquid biopsy platform that improves cancer
diagnostics and monitoring for patients around the world. The company
has developed and patented core technology for circulating cell-free DNA
NGS analysis and was the first to demonstrate identification of all four
major types of mutations in a blinded, clinical study. The company is
based in Kirkland, WA. For more information, visit www.resolutionbio.com.

Resolution Bioscience, the Resolution Bioscience logo, and Resolution
HRD are trademarks of Resolution Bioscience, Inc. All other brands may
be trademarks of their respective holders.

Contacts

Andrew Noble
415-722-2129
[email protected]