Press Releases

GenomeDx to Distribute Pathnostics’ Guidance UGx Test for Urinary Tract Infection and Guidance PRx Test for Prostatitis

Strategic Agreement Accelerates GenomeDx’s Product Expansion in Urologic Genomics

San Diego and Irvine, CA – September 14, 2017 – GenomeDx Biosciences, a leader in the field of urologic genomics, and Pathnostics, a provider of comprehensive and dynamic pathology services, today announced a strategic agreement for GenomeDx’s distribution of Pathnostics’ Guidance UGx and Guidance PRx. These molecular diagnostic tests for urinary tract infections (UTIs) and prostatitis, respectively, improve upon traditional urine culture by detecting the genomic sequence of pathogens, providing a faster and more comprehensive solution for physicians and their patients.

GenomeDx will have exclusive distribution rights for Guidance UGx and Guidance PRx in most of the US urology market, and Pathnostics will perform the testing at its CAP-accredited, CLIA-certified laboratory in Irvine, California.

“GenomeDx continues to drive the commercial adoption of genomic testing in urology through our proprietary Decipher classifier tests for prostate and bladder cancer and through strategic partnerships to expand our commercially available solutions,” said Doug Dolginow, M.D., chief executive officer of GenomeDx. “The management of UTIs and prostatitis is an area of great unmet medical need, and this partnership with Pathnostics allows us to provide a clinically superior solution to an antiquated technology in a way that is consistent with our focus on genomics and the urology market.”

David Baunoch, Ph.D., chief scientific officer of Pathnostics, commented, “UTI and prostatitis cases often consist of complex polymicrobial infections that are commonly misclassified using traditional urine culture. Guidance testing allows for pathogen identification and characterization of antibiotic resistance days earlier than culture methodologies. We believe that Guidance pathogen identification and resistance testing improves patient outcomes.”

Dave Pauluzzi, chairman of Pathnostics, added, “Given the great commercial adoption we have had to date, with over 50,000 patients already tested, it is the right time to partner with GenomeDx to bring this technology to the broader urology community. GenomeDx is a leader in genomics in urology, and Guidance UGx and Guidance PRx are natural complements to GenomeDx’s Decipher portfolio of genomic solutions.”

About Guidance UGx and Guidance PRx

Guidance UGx is a commercially available molecular diagnostic test that detects 25 microbial organisms associated with UTIs and determines the susceptibility of the infection to antibiotics considered for treatment. Guidance UGx is indicated for patients with recurrent or persistent UTI infections, patients with complicated UTIs, patients experiencing symptoms of a UTI who are immunocompromised, patients with interstitial cystitis, and asymptomatic bacteriuria pregnant women. Guidance PRx is a commercially available diagnostic test that detects 27 microbial organisms associated with acute prostatitis or chronic bacterial prostatitis and determines the susceptibility of the infection to antibiotics considered for treatment.

Traditional urine culture fails to identify the causative agent in two out of three UTIs, does not detect the presence of many causative agents of prostatitis, and often fails to detect polymicrobial infections. The Guidance UGx and Guidance PRx tests can detect more than one causative agent of both UTIs and prostatitis, utilizing polymerase chain reaction (PCR) to detect and quantitate microbial organisms in urine specimens. Following detection, antibiotic susceptibility is derived through a patented high-throughput spectrophotometric assay. The Guidance UGx and Guidance PRx reports provide the treating physician with a list of antibiotics most likely to resolve the infection, regardless of the number of causative agents.

About GenomeDx Biosciences and Decipher®

GenomeDx is reimagining the use of genomics as a platform for mass collaboration to improve patient treatment and outcomes through its commercially available genomic tests for prostate and bladder cancer as well as potential future tests. Decipher Biopsy is indicated for men with localized prostate cancer at diagnosis, Decipher RP is indicated for men after prostate removal surgery and Decipher Bladder is indicated for patients being considered for neoadjuvant chemotherapy prior to bladder removal surgery, and they are used by physicians to stratify patients into more accurate risk groups than determined by traditional diagnostic tools and to help determine which patients may be more likely to benefit from additional treatment. These tests are derived from GenomeDx’s Decipher Genomics Resource Information Database (GRID), which contains the genomic profiles of thousands of tumors from patients with urological cancers, and is believed by GenomeDx to be the largest shared genomic expression database in urologic cancer as well as one of the world’s largest global RNA expression databases using cloud-based analytics..

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