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.

西班牙巴塞罗那--（商业新闻短讯）--总部位于巴塞罗那的生物技术初创公司REVEAL GENOMICS，S.L.今天宣布了TNBCDX®的开发和临床验证，这是第一个专门为早期TNBC患者设计的基因组测试。

This dual milestone will be presented at the ESMO Congress 2024 in Barcelona (Spain)..

这一双重里程碑将在2024年巴塞罗那（西班牙）ESMO大会上呈现。。

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.

这种疾病通常用新辅助多药化疗方案治疗，包括紫杉烷，蒽环类药物，环磷酰胺，卡铂和派姆单抗。

However, these therapies often pose significant toxicities for patients and can lead to a considerable financial burden and increased use of healthcare resources..

然而，这些疗法通常会对患者产生严重的毒性，并可能导致相当大的经济负担和医疗资源的使用增加。

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..

同时，涉及紫杉烷和卡铂而不含蒽环类药物和派姆单抗的较不密集的全身治疗在选定的患者中显示出突出的结果。在这种情况下，需要TNBCDX®等生物标志物来指导治疗决策，并安全地识别可以从治疗降级中受益的患者。。

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..

在对418名患者进行的两项独立验证研究中，TNBCDX®评分显示与病理完全缓解（pCR），远处无病生存（DDFS）和总生存（OS）密切相关，从而提供了更精确的风险分层。。。

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.

西德研究小组的Nadia Harbeck博士和Oleg Gluz博士领导的第一项验证研究ADAPT-TN是一项II期前瞻性新辅助试验（WSG-ADAPT TN试验，NCT01815242），招募了诊断为I-III期TNBC的患者。该研究涉及nab-紫杉醇联合吉西他滨或卡铂的治疗方案。

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.

未达到pCR的患者接受了额外的蒽环类化疗。由Miguel Martin博士领导的第二项验证研究MMJ-CAR-2014-01（NCT01560663）是西班牙正在进行的一项前瞻性，多中心，非随机试验，研究新辅助卡铂和多西紫杉醇在早期TNBC中的抗肿瘤活性。

This study includes patients with stage I–III TNBC, treated with six cycles of carboplatin and docetaxel..

这项研究包括I-III期TNBC患者，接受六个周期的卡铂和多西紫杉醇治疗。。

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.

马德里格雷戈里奥-马拉尼翁大学总医院肿瘤内科主任、乳腺癌领域公认的领军人物米格尔-马丁博士将在定于2024年9月14日上午10:50在巴塞罗那礼堂举行的ESMO会议上介绍这项研究成果。

“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.

Miguel Martin博士评论道：“TNBCDX®的开发和验证是TNBC精确肿瘤学领域的重大成就。这项测试将使肿瘤学家能够更有效地定制治疗方法，为管理这种侵袭性乳腺癌的个人提供新的希望。”。

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.”.

他补充道：“TNBCDX®能够提供关键的基因组见解，特别关注免疫系统，标志着TNBC治疗迈出了重要的一步。”。

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.”

REVEAL GENOMICS®首席执行官兼联合创始人帕特里夏·维拉格拉萨（Patricia Villagrasa）博士补充道：“将TNBCDX®引入临床实践将改变诊断为TNBC的患者的治疗格局。我们致力于确保全球获得这一重要的诊断工具。”

About the TNBCDX® Test

关于TNBCDX®测试

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.

。该测试将临床变量与15个基因的关键肿瘤和免疫生物学因素相结合，以提供全面的风险评估，指导临床环境中的治疗决策。TNBCDX®包括两个评分：风险评分和pCR（病理完全缓解）可能性评分。

Additionally, the test measures the levels of ERBB2 to ensure that the tumor is accurately classified as TNBC..

此外，该测试测量ERBB2的水平，以确保肿瘤被准确分类为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.

TNBCDX®目前以仅供研究使用（RUO）的格式提供。该公司正在标准化检测方法，计划到2025年通过Clínic医院的生物医学诊断中心（CDB）提供。

About TNBC

关于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..

TNBC约占所有乳腺癌诊断的15-20%。与其他乳腺癌亚型不同，TNBC不表达雌激素受体，孕激素受体或HER2，因此更难用常规疗法治疗。TNBC以其侵略性和预后不良而闻名；然而，它也表现出巨大的生物学和临床异质性，强调需要更精确的诊断和治疗方法。。

About REVEAL GENOMICS®️

关于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.是一家生物技术初创公司，旨在改变生物标志物在肿瘤学中的使用方式。它专注于开发创新的诊断工具，以确定癌症患者的最佳治疗选择。该公司使用开创性的技术、复杂的计算机应用程序和机器学习来揭示新的癌症研究数据。。