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GenQual has two proprietary companion diagnostic candidates based on single nucleotide polymorphism (SNP) detection by real-time PCR, both with applications for autoimmune and inflammatory disorders. Our first candidate detects a key SNP on the interleukin-6 gene promoter, which has been identified as a key indicator of systemic onset of juvenile chronic arthritis and has been validated as a key indicator of treatment response.1,2,3 Our second candidate diagnostic detects a SNP on the STAT4 gene and has been associated with rheumatoid arthritis and systemic lupus erythematosus (SLE).4,5 GenQual holds key IP for IL-6 therapeutic decision making: Patent application #WO 2012/109427 PCT/US2012/024448 “Methods of Prognosing and Administering Treatment for Inflammatory Disorders”.

GenQual is seeking partnerships for validating these companion diagnostic candidates both in prospective clinical trials and in retrospective analysis of completed clinical trials–where outcome data is already known and sample retains are accessible (whole blood, synovial cells, serum, etc.), using as little as 100ng of extracted DNA.  Specific and measurable trial outcome measurements are highly preferred (i.e. DAS28, EULAR, ACR scores, etc). Key areas of interest include: rheumatoid arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, ankylosing spondylitis, Sjögren’s Syndrome Castleman’s Disease, acute graft versus host, and neuroblastoma, among others.

anti-IL-6 & anti-IL-6R
Our lead diagnostic candidate is for anti-IL-6 and anti-IL-6R therapeutics using qPCR detection of a SNP on the interleukin-6 gene promoter. Gene variants are categorized into predicted response classes.  GenQual would like to collaborate with drug developers to test our predictive power in a blinded format using primary and secondary outcome measures. Retrospective analysis can be rapidly performed for partner trials using existing sample retains, and where patient outcomes are already known.
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JAK/STAT inhibitors
GenQual is developing a diagnostic candidate using a SNP on the STAT4 gene for JAK/STAT inhibitors. Gene variants are categorized into predicted response classes. Predictive power can be tested using retrospective analysis using existing sample retains, and where patient outcomes are already known.
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anti-TNFa
Both our IL-6 promoter variant as well as our STAT4 SNP candidate diagnostics have peripheral validation for segregating anti-TNFa biologic recipients into response classes. GenQual would like to collaborate with drug developers to test our predictive power in a blinded format using primary and secondary outcome measures. As with all our candidate tests, retrospective analysis can be rapidly performed for partner trials using existing sample retains, and where patient outcomes are already known.

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