The DEFINITIVE trial will be conducted at the Brigham and Women’s Center for Advanced Molecular Diagnostics. Credit: Shutterstock / Jiri Hera

Spanish biotech start-up, Reveal Genomics, has announced the launch of a trial evaluating the clinical feasibility of its HER2DX genomic test designed for the diagnosis of HER2+ early-stage breast cancer.

The Barcelona-based firm announced the prospective trial (NCT06446882) in collaboration with the Boston-based research institute, the Dana-Farber Cancer Institute aimed at examining the turnaround time of the HER2DX test.

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The DEFINITIVE trial will be conducted at the Brigham and Women’s Center for Advanced Molecular Diagnostics using tumour samples taken from newly diagnosed HER2+ breast cancer patients.

The overall goal of the trial is to measure the tests potential to be used in the US market.

The study will also examine how the HER2DX test results influence therapeutic decisions made by Dana-Farber clinicians regarding patients with stage I-III HER2+ breast cancer as well as polling the confidence levels of clinicians and patients before and after the test. The Spanish company also says that its HER2DX test results currently have an average turnaround time of 8.1 business days. Typical assays generally take between one to three weeks to come back with results.

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CEO of Reveal Genomics, Patricia Villagrasa, said: “We are excited to see the HER2DX test being used in the US to improve clinical decision-making and patient outcomes. This collaboration with the Dana-Farber Cancer Institute is a significant milestone in our mission to enhance precision oncology through innovative biomarker solutions.”

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The overall market for companion diagnostics has been steadily growing in recent years, with research conducted by GlobalData finding that the market for oncology tests is expected to grow, with the global market estimated at being worth $1.9bn in 2022, with that figure expected to grow to more than $3.1bn in 2030.

Adrienne Waks, principal investigator for the study said: “In addition to its potential incorporation into clinical practice, the fact that the study analyses decision-making and collects information on physician and patient opinions makes the results of this study very powerful data for the routine use of the test.”

At the same time as studying the turnaround time of the diagnostic assay, Reveal Genomic says that the trial will also seek to assess a patient’s basic understanding of their disease and the HER2DX assay, as well as documenting the researcher’s choice of treatment before and after the results.

Elsewhere in the field of HER2+ breast cancer diagnostics, Precede Biosciences has announced positive results for its liquid biopsy assay, designed to classify human epidermal growth factor as well as predicting oestrogen receptor pathway activity in breast cancer.