Acupath First Commercial Lab to Offer URO17™, Innovative New Bladder Cancer Biomarker
Strategic Partnership formed with KDx Diagnostics
PLAINVIEW, N.Y., July 25, 2019 /Acupath Laboratories, Inc./ — Acupath Laboratories, Inc., a leading provider of sub-specialized anatomic and molecular pathology services, and KDx Diagnostics, Inc., a leading developer of bladder cancer tests, today announced that KDx has licensed Acupath to incorporate its URO17™ immunocytochemistry assay test into its enhanced bladder cancer detection program. Acupath received approval from the New York State Department of Health in June 2019, and is the first laboratory to offer the test in U.S. under a semi-exclusive license from KDx.
Bladder cancer is the 6 most common cancer in the U.S., with 81,000 new cancer cases annually, and a 75% recurrence rate. One of the most common and inexpensive screening tests, urine cytology, is largely ineffective and pathologically subjective, with limited sensitivity and specicity.
The URO17™ bladder cancer test was developed and key components manufactured by KDx, which was founded with a mission to improve bladder cancer detection. Acupath will utilize the marker as an adjunct to traditional thin prep urine cytology and in addition to Acupath’s FISH testing capabilities.
“Acupath is extremely excited about this collaboration with KDx Diagnostics Inc., and the signicant potential that URO17™ technology possesses in helping Acupath and our urology clients improve bladder cancer detection rates and save lives”, said John Cucci, Acupath’s Chief Sales & Strategy Officer.
“In the initial study, the URO17™ test exhibited 100% sensitivity, and 96% specificity (Babu et al., 2018), which was confirmed recently in a second study outlined in a poster presented at the 2019 American Association of Cancer Research meeting (100%sensitivity, 90% specificity, Bladder Cancer: Transforming the Field, AACR, Denver, CO),” said Nam Kim, Ph.D., CEO of KDx, and co-Inventor of the URO17™ technology. He added, “Acupath’s launch of the URO17™ test is a key milestone for KDx and her collaborators, and we are thrilled that the urology and pathology communities now for the first time have access to a unique test that we believe has the potential to revolutionize how bladder cancer is detected, managed, and treated.”
About Acupath Laboratories, Inc.
Founded in 1998 and based in Plainview, NY (Long Island), Acupath is a provider of sub-specialized anatomic pathology services focused on the following specialties; Urology, Gastroenterology, Dermatology, Women’s Health, Otolaryngology, Podiatry, and Hematology / Oncology. Acupath offers an extensive test menu on both a global and TC/PC basis, processes well over 150,000 specimens annually, and is one of the leading providers of cutting edge FISH testing for the detection of bladder cancer (UroVysion™), prostate cancer (PTEN ERG), breast cancer (PathVysion™), melanoma, and esophageal cancer (Barrett’s esophagus FISH). The company plans to offer a wide range of PCR based assays in late 2019, with the initial focus on Urology (urinary tract infections) and Podiatry (nail and wound care).
About KDx Diagnostics, Inc.
Founded in 2017, KDx is focused on developing non-invasive cancer tests to improve early detection and therapy decisions in cancer. The URO17™ bladder cancer test developed by KDx may prove to be the most sensitive and specific test for bladder cancer developed to date. KDx plans to develop the test for other platforms and sample types and then expand its product line into other cancer tests. URO17 is a trademark of KDx.