DiaCarta, a precision diagnostic company focused on cancer and infectious diseases, has formed a strategic collaboration with Irish medical diagnostics company OncoAssure.

The collaboration aims to commercialise OncoAssure’s advanced Prostate test, designed to identify patients with a lower risk of prostate cancer recurrence.

OncoAssure’s Prostate prognostic test is a six-gene expression assay that detects the risk of aggressive disease and the risk of biochemical recurrence over five years after diagnosis.

The test also guides decisions on active surveillance or reduced monitoring after treatment.

OncoAssure CEO Des O’Leary said: “We are delighted to collaborate with DiaCarta. 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 commercialization of the OncoAssure Prostate LDT test, benefiting healthcare providers and patients alike.”

The collaboration will leverage DiaCarta’s expertise in providing clinical diagnostic services to complete the Laboratory Developed Test (LDT) validation for the OncoAssure Prostate test.

It also includes the application to the Centers for Medicare & Medicaid Services (CMS) for coding, billing, and reimbursement.

DiaCarta is a molecular diagnostics company engaged in the development of technologies that transform patient care with effective precision diagnostics using liquid biopsy.

The company’s XNA technology is designed to provide superior sensitivity by clamping the wild-type sequence and selectively amplifying only mutant target sequences.

DiaCarta has developed the ColoScape colorectal cancer mutation test using XNA technology.

Also, the company has developed its RadTox test using isobDNA technology, to personalise radiation and chemotherapy, mitigate adverse events, and enhance patient care.

DiaCarta CEO and president Adam Zhang said: “We are very pleased to collaborate with OncoAssure to bring the best-in-class highly accurate OncoAssure Prostate LDT test to commercialization 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.”