Benzinga | Oct 13, 2020 07:34AM EDT

Nephros Announces Release Of DialyPath qPCR-based, Real-time, On-Site Endotoxin Assay For Dialysis Water

SOUTH ORANGE, NJ, Oct. 13, 2020 (GLOBE NEWSWIRE) -- via NewMediaWire -- Nephros, Inc. (NASDAQ:NEPH), a commercial-stage company that develops and sells high performance water purification products and pathogen detection systems to the medical and commercial markets, today announced availability of DialyPath(tm), an assay that estimates endotoxin levels in dialysis water samples.



Water sampling is generally required in dialysis clinics to ensure that no waterborne contamination is present. Of particular interest are endotoxins, which are gram-negative bacterial fragments that can cause inflammation and other complications in dialysis patients. DialyPath is an on-site test that measures endotoxin levels in about two hours.

DialyPath results correlate highly (R2>0.95) with data from the limulus amebocyte lysate (LAL) assay, currently the industry standard for endotoxin measurement (EU/ml). DialyPath uses qPCR technology to quantify DNA target segments in a water sample, which are matched to a DNA segment that is found in all gram-negative bacteria. From these results, DialyPath uses proprietary algorithms to estimate the number of endotoxin units in a dialysis water sample.

"We are very excited to launch DialyPath," said Kimothy Smith, DVM, PhD, Vice President of Pathogen Detection Systems at Nephros. "It is an extremely sensitive assay, with a 0.001 EU/ml lower limit of quantification (LLOQ), compared to an LLOQ of 0.1 EU/ml for most LAL assays."

Dr. Smith continued, "Water sampling today is largely performed at off-site laboratories, typically requiring 2-3 days to produce actionable results. By comparison, DialyPath is an on-site test, providing results within 2 hours. This will allow biomedical engineers to more quickly diagnose, correct and recommission dialysis water treatment systems. "

DialyPath was designed to deliver real-time endotoxin data to biomedical engineers in dialysis clinics and hospitals, who need to make decisions on dialysis water systems for patient well-being. With broader market experience and validation, Nephros believes that DialyPath could replace the LAL assay for the routine testing of dialysis water and dialysate. Nephros is currently generating a large data set to validate DialyPath for a wide range of on-site conditions and water samples and plans to publish this data in a peer-reviewed journal in the future.

It is also worth noting that the LAL assay requires the use of blood cells from the Atlantic horseshoe crab, which is an endangered species. DialyPath does not require the use of horseshoe crabs. It utilizes only materials from synthetic chemistry and bacterial cell culture extractions.