GenomeDx Biosciences and Pathnostics have launched 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.

"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."

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.