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 News Release - June 19, 2018

GenomeDx Biosciences and Pathnostics Launch Enhanced Version of Guidance Tests

Now Offering Both Phenotype and Genotype Testing for Antibiotic Resistance

SAN DIEGO and Irvine, Calif., June 19, 2018 -- (Healthcare Sales & Marketing Network) -- GenomeDx Biosciences and Pathnostics today announced the launch of the next generation Guidance testing for patients suffering from simple cystitis, recurrent, persistent or complicated urinary tract infections (UTI), prostatitis and interstitial cystitis (IC). The Guidance test is performed by Pathnostics and distributed by GenomeDx to urologists. This molecular test expands GenomeDx's commercially available solutions for the urology market.

Guidance is a rapid diagnostic test that helps personalize treatment options through the swift identification of 42 pathogens followed by antibiotic sensitivity for the collection of identified pathogens, and this next generation of Guidance adds the evaluation of the presence of antibiotic resistant genes. This dual, patent-pending approach to antibiotic sensitivity is believed to provide more reliable information than traditional urine culture with respect to the evaluation of treatment options for patients with polymicrobial (multiple pathogens) infections and/or infections with slow growing pathogens. Further, results are available 24-48 hours after a patient's specimen arrives to the lab.

"GenomeDx is committed to leveraging genomic information to transform and improve patient care," said Edwin Hendrick, chief commercial officer of GenomeDx. "In addition to our proprietary Decipher tests for prostate and bladder cancers, we are excited to offer this enhanced version of Guidance for urologic infections."

"We value our partnership with GenomeDx to bring this unique product to the urology marketplace," said David Pauluzzi, chairman of Pathnostics. "Our proprietary technology, combined with testing at our CAP-accredited, CLIA-certified laboratory in Irvine, California, provides a faster, more comprehensive solution for urologists and their patients."

"Relying on standard urine cultures to diagnose chronic urologic infections has significant disadvantages, such as failing to consistently detect polymicrobial infections. In contrast, Guidance is a novel molecular and antibiotic sensitivity test that we believe can point the way to the best therapeutic options, thereby potentially providing more favorable patient outcomes and, in the big picture, lower healthcare costs," said David Baunoch, PhD, chief scientific officer of Pathnostics. "Detecting resistance genes, paired with our present-day antibiotic sensitivity testing, makes Guidance an ideal diagnostic tool for physicians in their efforts to rapidly determine the best treatment option for their patients and be good stewards of antibiotics."

About Guidance

Guidance is a commercially available molecular diagnostic test that detects 42 microbial organisms associated with chronic urologic infections, determines antibiotic sensitivity, and identifies the resistance genes to determine the susceptibility of the infection to antibiotics considered for treatment. Guidance 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 prostatitis and patients with interstitial cystitis.

According to Pathnostics' studies, traditional urine culture, as compared to Guidance, fails to identify as many causative agents in two out of three UTIs, does not detect the presence of many causative agents of prostatitis, and often fails to detect polymicrobial infections. Guidance 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 proprietary high-throughput spectrophotometric assay. Guidance reports provide physicians with a list of antibiotics most likely to resolve the infection, regardless of the number of causative agents.

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About GenomeDx Biosciences

GenomeDx is reimagining the use of genomics as a platform for mass collaboration to improve patient treatment and outcomes through its currently available genomic tests for prostate and bladder cancer as well as potential future tests. GenomeDx has offices in Vancouver, British Columbia and San Diego, California.

Source: GenomeDx Biosciences

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