REVEAL GENOMICS® Unveils TNBCDX®: the First Genomic Test Designed for Early-stage Triple-Negative Breast Cancer

• TNBCDX^® is the first genomic test designed specifically for patients with early-stage Triple-Negative Breast Cancer (TNBC).
• Across two independent validation studies with 418 patients, the TNBCDX^® scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS).
• The results will be presented at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona (Spain) on Saturday, September 14^th.

BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, today announced both the development and the clinical validation of TNBCDX^®, the first genomic test designed specifically for patients with early-stage TNBC. This dual milestone will be presented at the ESMO Congress 2024 in Barcelona (Spain).

TNBCDX^® represents a significant advancement in the management of TNBC, a subtype of breast cancer that is particularly challenging to treat due to its lack of hormone receptors and HER2 expression. This disease is typically treated with neoadjuvant multi-agent chemotherapy regimens that include taxanes, anthracyclines, cyclophosphamide, carboplatin, and pembrolizumab. However, these therapies often pose significant toxicities for patients and can lead to a considerable financial burden and increased use of healthcare resources.

Meanwhile, less intensive systemic therapies involving taxanes and carboplatin without anthracyclines and pembrolizumab are showing outstanding outcomes in selected patients. In this context, a biomarker such as TNBCDX^® was needed to guide treatment decisions and safely identify patients who could benefit from de-escalation of therapy.

Across two independent validation studies with 418 patients, the TNBCDX^® scores showed a strong association with pathological complete response (pCR), distant disease-free survival (DDFS), and overall survival (OS), providing a more refined risk stratification. Notably, the TNBCDX^® test outperformed tumor-infiltrating lymphocytes (TILs) in predicting both pCR and survival outcomes.

The first validation study, ADAPT-TN, led by Dr. Nadia Harbeck and Dr. Oleg Gluz of the West German Study Group, was a phase II prospective neoadjuvant trial (WSG-ADAPT TN Trial, NCT01815242) that enrolled patients diagnosed with stage I–III TNBC. The study involved a treatment regimen of nab-paclitaxel combined with either gemcitabine or carboplatin. Patients who did not achieve a pCR were given additional anthracycline-based chemotherapy. The second validation study, MMJ-CAR-2014-01 (NCT01560663), led by Dr. Miguel Martin, is an ongoing prospective, multicenter, nonrandomized trial in Spain investigating the antitumor activity of neoadjuvant carboplatin and docetaxel in early-stage TNBC. This study includes patients with stage I–III TNBC, treated with six cycles of carboplatin and docetaxel.

Dr. Miguel Martin, Chair of Medical Oncology at the Hospital General Universitario Gregorio Marañón in Madrid, and a recognized leader in breast cancer, will present the findings during the ESMO session scheduled for 10:50 a.m. on September 14th, 2024, at Barcelona Auditorium.

“The development and validation of TNBCDX^® are significant achievements in the field of precision oncology for TNBC. This test will enable oncologists to tailor treatments more effectively, offering new hope for individuals managing this aggressive form of breast cancer,” commented Dr. Miguel Martin. He added, “The ability of TNBCDX^® to provide critical genomic insights, with a special focus on the immune system, marks an important step forward in the treatment of TNBC.”

Dr. Patricia Villagrasa, CEO and Co-founder of REVEAL GENOMICS^®, added, “The introduction of TNBCDX^® into clinical practice will transform the treatment landscape for those diagnosed with TNBC. We are committed to ensuring global access to this important diagnostic tool.”

About the TNBCDX^® Test
TNBCDX^® is the first genomic test designed specifically for patients with early-stage TNBC. The test integrates clinical variables with key tumor and immune biological factors across 15 genes to provide a comprehensive risk assessment, guiding treatment decisions in a clinical setting. TNBCDX^® includes two scores: a risk score and a pCR (pathological complete response) likelihood score. Additionally, the test measures the levels of ERBB2 to ensure that the tumor is accurately classified as TNBC.

TNBCDX^® is currently available in a Research Use Only (RUO) format. The company is in the process of standardizing the assay, with plans to offer it through the Biomedical Diagnostic Center (CDB) at Hospital Clínic by 2025.

About TNBC
TNBC accounts for approximately 15-20% of all breast cancer diagnoses. Unlike other breast cancer subtypes, TNBC does not express estrogen receptor, progesterone receptor, or HER2, making it more difficult to treat with conventional therapies. TNBC is known for its aggressive nature and poor prognosis; however, it also exhibits substantial biological and clinical heterogeneity, underscoring the need for more precise diagnostic and therapeutic approaches.

About REVEAL GENOMICS^®️
REVEAL GENOMICS, S.L. is a biotechnology start-up 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 patients with cancer. The company uses pioneering techniques, sophisticated computer applications, and machine learning to reveal new cancer research data.

REVEAL GENOMICS, S.L. is a spin-off of Hospital Clínic of Barcelona, IDIBAPS, University of Barcelona (U.B.), and Vall d’Hebron Institute of Oncology (VHIO).

REVEAL GENOMICS^® and TNBCDX^® are registered trademarks of REVEAL GENOMICS, S.L.

Web: www.reveal-genomics.com. X: @revealgenomics