The test is designed to predict the risk of recurrence of HER2+ breast cancer, as well as the likelihood of patients responding to pharmacological therapy.
It is claimed to be the first specialised genomic test for HER2+ breast cancer in the world.
The new tool is a 27-gene plus clinical feature-based classifier and offers accurate estimates of the risk of disease recurrence and the probability of therapy response to anti-HER2 drugs in early-stage HER2+ breast cancer.
It uses smart analytical software to separate patients into high- and low-risk groups.
The company stated that the HER2DX algorithm was derived from 434 patient datasets and was validated in an external 268 patient datasets.
It has also been evaluated using data from more than 1,000 patients that was available from public datasets.
HER2DX combines the clinical data of a patient and the genomic profile of the tumour.
Reveal Genomics CEO Dr Patricia Villagrasa-Gonzalez said: “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.”
Using digital multiplex technology, HER2DX measures the expression of 27-genes from Formalin-Fixed, Paraffin-Embedded (FFPE) breast cancer tissues.
At present, it is offered as a Laboratory Developed Test (LDT), and results are delivered in seven to ten working days.
Since January, the test has been available in Spain and will be launched in other markets soon