DiaCarta and OncoAssure Collaborate to Launch Prostate Cancer Test

Pleasanton, California, and Dublin, Ireland, 26 February 2024, DiaCarta, Inc. ("DiaCarta"), a pioneer in molecular diagnostic test development for cancer and infectious diseases, based in California, today announced that it has established a strategic collaboration with OncoAssure Ltd, an Irish medical diagnostics company headquartered at NovaUCD in Dublin.

The focus of the collaboration is to commercialise OncoAssure’s groundbreaking prostate test which is  designed to identify patients with a lower risk of prostate cancer recurrence, guiding decisions on active surveillance or reduced monitoring, post-treatment.

OncoAssure's prostate prognostic test is a 6-gene expression assay that assesses the risk of aggressive disease post-diagnosis and the risk of biochemical recurrence over a 5-year period post-surgery.

The collaboration aims to leverage DiaCarta's expertise in customisable clinical diagnostic services to facilitate the completion of the Laboratory Developed Test (LDT) validation for the OncoAssure prostate test. The collaboration also includes the application to the Centers for Medicare & Medicaid Services (CMS) for coding, billing, and reimbursement.

“We are delighted to collaborate with DiaCarta,” said Des O’Leary, CEO of OncoAssure. “DiaCarta has established a high-quality CAP/CLIA laboratory for LDT testing in California. This partnership will expedite the validation process and pave the way for commercialisation of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike.”

Dr Adam (Aiguo) Zhang, CEO and President of DiaCarta, added, “We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialisation in DiaCarta’s CAP/CLIA laboratory. The OncoAssure team has a proven track record for developing high quality prognostic tests including the OncoMasTR breast cancer prognostic test acquired by Cepheid in 2021. The unique OncoAssure Prostate prognostic test addresses an unmet need in prostate cancer management and is a valued addition to DiaCarta’s portfolio of molecular diagnostic tests for cancer that includes tests for bladder and colorectal cancer.”

ENDS

26 February 2024

For further information contact Micéal Whelan, Communications and Media Relations  Manager, UCD Research and Innovation, e: miceal.whelan@ucd.ie or Anne Vallerga, PhD, MBA, Vice-President External Affairs, DiaCarta, e: annek@diacarta.com or Des O’Leary, CEO, OncoAssure, e: des.oleary@oncoassure.com.                  

DiaCarta is a molecular diagnostics company at the forefront of developing innovative technologies to transform patient care by providing effective precision diagnostics using liquid biopsy. The Company’s novel XNA technology is designed to provide a high level of sensitivity by “clamping” the wild-type sequence and selectively amplifying only mutant target sequences. Using this technology, DiaCarta has developed its ColoScape™ colorectal cancer mutation test.

Powered by its isobDNA™ technology that amplifies the signal and requires no RNA/DNA extraction or amplification, DiaCarta has developed its RadTox™ test to personalize radiation and chemotherapy, mitigate adverse events, and enhance patient care. Headquartered in Pleasanton, California, DiaCarta is ISO certified, GMP-compliant, and offers CAP/CLIA certified laboratory services. www.diacarta.com

OncoAssure Ltd is a medical diagnostics company headquartered at NovaUCD in Dublin. The company focuses on identifying, developing, and commercializing clinically important biomarkers to significantly improve cancer management and treatment. Utilizing the novel “OncoAssure Process” the key drivers of cancer progression are identified and transformed into an analytical and clinically validated test. 

In addition to the validated Prostate test, OncoAsssure has in development a prognostic test for Cutaneous melanoma and has identified a pipeline of tests to address unmet needs in Oesophageal, Colorectal and Squamous Cell Carcinoma.  OncoAssure's mission is to help clinicians provide the right treatment to the right patient at the right time. www.oncoassure.com