nRichDX and OraSure Advance Commercial Collaboration to Create Preanalytical Solutions for the Urine-based MDx Market

OraSure's Colli-Pee® First-Void Urine Collection and Preservation Device and nRichDX Revolution Sample Prep System for cfDNA Extraction

IRVINE, Calif., March 27, 2023 /PRNewswire/ -- nRichDX and OraSure Technologies, Inc., have 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.

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, and preserve the cell-free nucleic acid (cfDNA, including circulating cell-free tumor DNA, and cfRNA) with its proprietary UAS™ reagent. nRichDX's patented Revolution Sample Prep System™ is the only IVD-labeled, cfDNA sample prep system that can process up to 20 mL of urine in a single extraction.

Together, the Colli-Pee first-void urine collection device with UAS preservative, combined with the nRichDx Revolution System, a semi-automated cfDNA extraction platform, offers a seamless and efficient workflow for large-scale studies requiring urine sample collection, preservation, handling and extraction for downstream processing.

"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," said William Curtis, CEO of nRichDX. "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" he said.

"First-void urine collection is convenient for patients and provides important insight into the state of their health," said Kathleen Weber, Chief Product Officer for OraSure. "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."

The companies have jointly presented data for cfDNA and ctDNA yields from first-void urine at last November's Association for Molecular Pathology (AMP) Meeting, as well as codeveloping an Application Note and have plans to present at upcoming industry conferences and in future publications.

Researchers and clinicians interested in learning more about this complete preanalytical solution for urine-based assays may contact their local representatives, or visit Novosanis at www.novosanis.com, or www.nrichdx.com, or the Novosanis & nRichDX resources webpage at www.nrichdx.com/urine_liquid_biopsy_resources. 

About 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. It is the first and only high-yield, high-recovery, IVD-labeled sample prep platform that can process from 1 mL - 20 mL of plasma or urine sample volumes in a single extraction using the company's unique nRicher Cartridge™. Unlike other methods, Revolution sample prep doesn't require yield-lowering sample pooling, bead recycling, or sample transfer steps. nRichDX helps solve one of precision medicine's greatest problems – – inaccurate or incomplete diagnostic results for liquid biopsy-based applications due to insufficient analyte. www.nrichdx.com

About 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 its customers with end-to-end solutions that encompass tools, services and diagnostics. The OraSure family of companies is a leader in the development, manufacture, and distribution of rapid diagnostic tests, sample collection and stabilization devices, and molecular services solutions designed to discover and detect critical medical conditions. OraSure's portfolio of products is sold globally to clinical laboratories, hospitals, physician's offices, clinics, public health and community-based organizations, research institutions, government agencies, pharma, commercial entities and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

About Novosanis:

Novosanis, a subsidiary of OraSure Technologies, Inc., is an innovator of first-void urine (FVU) urine sample collection with the Colli-Pee® sample collection device family to improve the quality of diagnostic tests for infectious diseases and oncology. The Colli-Pee® devices provide non-invasive, self-collected, and volumetric sampling to standardize FVU collection, with a unique design to enable the immediate mixing of urine and preservative for FVU sample stability. Offering various sizes to capture a range of urine volumes for different application purposes, Novosanis is pioneering FVU sample collection as an alternative to invasive sampling -demonstrated by strong clinical research outcomes, patient preference and affordability. 

nRichDX Media Contact: Tom Curtis
Email: [email protected]
Phone: (949)341-1980 x6

OraSure Media Contact: Amy Koch
Email: [email protected]
Phone: (484)-523-1815

SOURCE nrichdx