World's First Genomic Test for Personalized HER2+ Breast Cancer Treatment Could Revolutionize Precision Oncology

By LabMedica International staff writers
Posted on 18 Feb 2022

Image: HER2DX test (Photo courtesy of REVEAL GENOMICS, S.L.)

A new test predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to pharmacological treatment.

REVEAL GENOMICS, S.L. (Barcelona, Spain) has launched the HER2DX, the world's first specialized genomic test for HER2+ breast cancer, which combines a patient's clinical data and the tumor's genomic profile. HER2DX is a 27-gene plus clinical feature-based classifier that provides accurate estimates of the risk of recurrence and the probability of achieving a response to anti-HER2 drugs in early-stage HER2+ breast cancer.

HER2DX uses smart analytical software to stratify patients into low- and high-risk groups. The HER2DX algorithm was derived from a dataset of 434 patients and was validated in an external dataset of 268 patients. The algorithm was also validated using the data of more than 1,000 patients available from public datasets. HER2DX is performed on RNA isolated from FFPE breast cancer tissues where only one sample is necessary. The results are obtained in 7-10 working days. The current assay measures the expression level of 27-genes by digital multiplex technology, and then REVEAL GENOMICS proprietary software, weighted together with clinical variables, outputs an individual patient-level risk score and a pCR likelihood score.

The HER2DX test was launched in Spain in January 2022 and the company now hopes to see HER2DX become the routine test option in public and private hospitals. Consequently, it is currently conducting the required clinical studies so that the test is recommended in national and international clinical guidelines and so that it can be covered by health reimbursement arrangements in the short term.

"This is our first product launch. It encapsulates our vision, which is to help patients and physicians improve outcomes and quality of life by using more accurate information," said Dr. Patricia Villagrasa-Gonzalez, CEO of REVEAL GENOMICS.

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REVEAL GENOMICS, S.L.