Collaborate with GenQual
What we do
At GenQual, we develop proprietary companion diagnostics for inflammatory diseases. Our diagnostic candidates are designed to stratify patient cohorts for clinical trials, improve response rates, optimize the regulatory approval pathway, reduce treatment costs, and ultimately, to inform treatment decisions. GenQual is a privately-held corporation based in the greater Seattle, WA area.
Improve response rates
The goal our anti-IL-6/IL-6R companion diagnostic candidate is to identify responsive patients, prior to drug treatment. Non-responder classes can then be removed from the overall treatment cohort and be given an alternative treatment pathway. Targeting therapeutics specifically to receptive patients will improve overall response rates.
Reduce risk
Using companion diagnostics reduces program risk and patient risk. Reducing poor response statistics, confounding or ambiguous results, and repeated trial components insures the sponsor company in critical clinical trial aspects.

Eliminating exposure to non-response cohorts protects the patient from deleterious adverse events and improves the drug safety profile.

Clarify regulatory pathway
Approach conforms with FDA draft guidance and working groups recommending use of diagnostics to identify responders and to deselect non-responders to protect from adverse events.
Competitive advantage
GenQual is unique in its ability to provide access to our proprietary IL-6/IL-6R and JAK/STAT pathway inhibitor diagnostic candidates.  We have applied for international patent protection over our diagnostic discoveries, which is currently in the national-phase filing stage. We alone can provide this diagnostic logic to your anti-IL-6/IL-6R drug program.  Improving trial statistics using this approach is one key benefit that may give a clear advantage over approved biologics and those currently in development.

Team Members
Jonathan Mirich
Founder & CEO
Mr. Mirich founded GenQual with the goal developing methods for rapid identification of responsive patients to expensive biologics for inflammatory disorders–prior to drug dosing.

From 2003 to 2009 he served at gene therapy pioneer Targeted Genetics Corp. as Sr. Quality Control Analyst. He primarily specialized in assay transfer, optimization, and validation of various analytical methods including bioassay, infectious titer, replication-competent virus, ELISA, and qPCR, using statistical analysis in support of clinical trials.  Mr. Mirich formerly served as a Research Technician at the Genito-Urinary Cancer Research Laboratory at the University of Washington. He attended Seattle Pacific University, Dept. of Biology.

Yury Colton, Ph.D., J.D.
COO & General Counsel
Dr. Colton has technical and legal experience in broad areas of the life science industry, including molecular diagnostics. Prior to joining GenQual, he worked as a patent attorney managing domestic and international patents for large and small companies and research institutions.

His scientific research included the exploration of genetic polymorphisms linked to the transmission of vector-borne diseases such as malaria. Dr. Colton earned a Ph.D. from the University of Notre Dame and a J.D. from Brigham Young University.

Ralph Paul, Ph.D.
Technical Advisor & Co-Investigator
Dr. Paul has comprehensive experience in the Biotech industry in a number of capacities–bench level scientist, Sr. Scientist, Program Lead and Director, grant and RFP preparation, business development, patent filings, licensing, and drug development. He was the Sr. Product Manager at Cerep and the Director of Technology Assessment and Discovery while at Targeted Genetics Corp. He currently serves at Abcam as a Scientific Support Supervisor.

Dr. Paul received his Ph.D. in Molecular Virology at University of Calgary and he performed his post-doc studies in retrovirology at Oregon Health and Science University School of Medicine.

Collaborators