REVEAL GENOMICS® Markets HER2DX®, The World's First Genomic Test for Personalized HER2+ Breast Cancer Treatment

February 17, 2022
  • HER2DX® predicts survival outcomes and the likelihood that patients will respond to pharmacological treatment.
  • The test, available in Spain since January, will be launched soon in other markets.
  • It has been validated in more than 1,000 patients, and the results have been published in The Lancet's EBioMedicine.

08:00 AM Eastern Standard Time

BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up that is seeking to revolutionize precision oncology through diagnostic innovation, has launched its first genomic test. The HER2DX® test predicts the risk of HER2+ breast cancer recurrence in newly diagnosed patients and the likelihood that they will respond to pharmacological treatment. This innovative tool, which combines a patient's clinical data and the tumor's genomic profile, is the world's first specialized genomic test for HER2+ breast cancer.

"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," says Dr. Patricia Villagrasa-Gonzalez, CEO of REVEAL GENOMICS®.

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® is currently provided as a Laboratory Developed Test (LDT) whose quality system is based on the UNE-EN-ISO 9001:2015 standard for collecting, receiving, and processing biological samples. It is also undergoing ISO 15189 accreditation. The reliability of the test has been described in a study1 published in The Lancet's EBioMedicine.

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.

An excellent debut on the diagnostic test market
As a result of the launch of the HER2DX® test in Spain in January of this year, the company has already signed deals with Spanish private hospitals, which now include the test in their treatment portfolio. "Based on our stepwise reimbursement approach, we are initially targeting hospitals in Spain and Italy and will subsequently be expanding to other E.U. countries and the U.S., where we are exploring marketing strategic partners," Dr. Villagrasa-Gonzalez explains.

Another goal of the company for upcoming years is 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.

Dr. Villagrasa-Gonzalez adds that "over the past few months, we have put a lot of effort into bringing HER2DX® to market. Considering that the company has only been in existence for 18 months, to have developed and brought our first product to market is definitive proof that we have a solid project.

REVEAL GENOMICS® was incorporated in September 2020 with private funding. This year, the company plans to increase its capital with injections from additional private sources. Moreover, it is preparing a round of Series A funding for 2023 to provide the initial boost for its international expansion.

REVEAL GENOMICS, S.L. is a biotechnology start-up that is seeking to change the way biomarkers are used in oncology. It is focused on developing innovative diagnostic tools to define the best therapeutic options for cancer patients. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.
It is a spin-off of Hospital Clínic de Barcelona, IDIBAPS, the University of Barcelona (UB), and the Vall d'Hebron Institute of Oncology (VHIO).
REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.

Twitter: @revealgenomics

1 Development and validation of the new HER2DX assay for predicting pathological response and survival outcome in early-stage HER2-positive breast cancer. Prat A et al. EBioMedicine. 2022 Jan 3;75:103801.

Further information: Adriana Herrera.