View the official press release distributed through PR Newswire.
OraSure's Colli-Pee® First-Void Urine Collection and Preservation Device and the nRichDX Revolution Sample Prep System for cfDNA extraction.
IRVINE, Calif., March 27, 2023 – nRichDX and OraSure Technologies, Inc. advanced a commercial collaboration to validate and co-promote their products for researchers developing liquid biopsy applications using first-void urine samples.
Notably, first-void urine is enriched in biomarkers suitable for molecular analysis in applications such as sexually transmitted infections, human papillomavirus, and early-stage cancer.
A Preanalytical Workflow for Urine-Based Molecular Testing
Collection, preservation, handling, and extraction in a complementary urine-based workflow.
Colli-Pee® collection of a consistent, volumetric first-void urine sample
UAS™ reagent for preservation of cell-free nucleic acids
Revolution Sample Prep System™ for downstream extraction of cfDNA and cfRNA
Workflow designed for large-scale urine-based research studies
First-Void Urine Collection Meets Sample Preparation
The companies' products are highly complementary. The innovative, patented Colli-Pee® sample collection and preservation device, made by OraSure's subsidiary Novosanis, is designed to hygienically collect a consistent, volumetric first-void urine sample.
The device preserves cell-free nucleic acids, including cfDNA, circulating cell-free tumor DNA, and cfRNA, using its proprietary UAS™ reagent.
At the time of the announcement, the nRichDX Revolution Sample Prep System™ was described as the only IVD-labeled cfDNA sample prep system capable of processing up to 20 mL of urine in a single extraction.
A More Complete Preanalytical Solution
Together, the Colli-Pee first-void urine collection device with UAS preservative and the nRichDX Revolution System, described in the 2023 announcement as a semi-automated cfDNA extraction platform, offered a workflow for large-scale studies requiring urine sample collection, preservation, handling, and extraction for downstream processing.
Explore Urine Liquid Biopsy Resources“nRichDX is pleased to collaborate with OraSure to provide researchers and clinicians solutions to deliver the highest yields of highly pure cfDNA and ctDNA from urine.”
“Liquid biopsy test developers are looking forward to the creation of highly sensitive assays from non-invasive urine samples. The unique Revolution System, together with the innovative Colli-Pee® device, delivers unmatched yields of cfDNA and ctDNA from urine,” Curtis said.
“First-void urine collection is convenient for patients and provides important insight into the state of their health.”
“We are excited about this collaboration, which utilizes the Colli-Pee® device for first-void urine collection and preservation of important biomarkers that can be extracted with the nRichDX Revolution System. We look forward to the possibilities that higher DNA yields can enable as researchers look for ways to use first-void urine as a more accessible, non-invasive liquid biopsy sample type to expand the potential for global screening, detection, and monitoring of cancers and other medical conditions,” Weber said.
Building Evidence for Urine-Based Liquid Biopsy
The companies had jointly presented data for cfDNA and ctDNA yields from first-void urine at the Association for Molecular Pathology meeting in November 2022.
They also co-developed an Application Note and stated plans to present at additional industry conferences and in future publications.
Explore Reference MaterialsAbout nRichDX
nRichDX® is an emerging leader in sample prep solutions for the isolation of cfDNA, ctDNA, RNA and other rare analytes. The patented Revolution Sample Prep System™ was engineered specifically for liquid biopsy applications.
At the time of the announcement, the platform was described as the first and only high-yield, high-recovery, IVD-labeled sample prep platform that could process from 1 mL to 20 mL of plasma or urine in a single extraction using the company's unique nRicher Cartridge™.
The announcement stated that Revolution sample preparation did not require yield-lowering sample pooling, bead recycling, or sample transfer steps.
Learn more about nRichDXAbout OraSure Technologies, Inc.
OraSure empowers the global community to improve health and wellness by providing access to accurate, essential information.
OraSure, together with its wholly owned subsidiaries, DNA Genotek, Diversigen, and Novosanis, provides customers with end-to-end solutions encompassing tools, services, and diagnostics.
The OraSure family of companies develops and distributes rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions.
Visit OraSure TechnologiesAbout Novosanis
Novosanis, a subsidiary of OraSure Technologies, Inc., is an innovator of first-void urine sample collection with the Colli-Pee® sample collection device family.
The Colli-Pee® devices provide non-invasive, self-collected, volumetric sampling designed to standardize first-void urine collection and enable immediate mixing of urine and preservative for sample stability.