BARCELONA, Spain--(BUSINESS WIRE)--REVEAL GENOMICS, S.L., a Barcelona-based biotechnology start-up seeking to revolutionize precision oncology through biomarker innovation, today announced the results of the study “HER2DX ERBB2 mRNA assay Following Trastuzumab-Based Chemotherapy in HER2-Positive Advanced Gastric Cancer” presented at ESMO Gastrointestinal Cancers Congress 2024 in Munich, showing that HER2DX® genomic test demonstrates significant potential in refining patient selection for trastuzumab-based chemotherapy in HER2-positive advanced gastric cancer..

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.今天宣布了在慕尼黑举行的2024年ESMO胃肠道癌症大会上发表的“HER2阳性晚期胃癌曲妥珠单抗化疗后HER2DX ERBB2 mRNA检测”研究结果，表明HER2DX®基因组检测在改进HER2阳性晚期胃癌曲妥珠单抗化疗患者选择方面显示出巨大潜力。。

HER2+ advanced gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers. The HER2DX® is a promising tool for enhancing patient selection by quantifying ERBB2 mRNA expression levels, and classifying tumor samples into different groups: low, medium, and high..

HER2+晚期胃癌治疗对曲妥珠单抗加化疗显示出不同的反应，表明需要精确的生物标志物。HER2DX®是一种有前途的工具，可通过量化ERBB2 mRNA表达水平，并将肿瘤样本分为低，中，高三组来增强患者选择。。

Patricia Villagrasa, REVEAL GENOMICS' CEO, says, “This study marks the first time that HER2DX® has been applied outside of breast cancer, illustrating its precision and potential across different oncological applications. Our findings underscore the test’s capability to improve patient selection, fundamentally transforming the treatment approach for those battling advanced gastric cancer.

REVEAL GENOMICS首席执行官帕特里夏·维拉格拉萨（Patricia Villagrasa）表示：“这项研究标志着HER2DX®首次在乳腺癌之外应用，说明了其在不同肿瘤学应用中的准确性和潜力。我们的发现强调了该测试改善患者选择的能力，从根本上改变了治疗晚期胃癌的方法。

This represents a significant milestone in our ongoing commitment to advance personalized medicine.”.

这是我们持续致力于推进个性化医疗的一个重要里程碑。”。

Dr. Tamara Saurí, medical oncologist, coordinator of upper- gastrointestinal cancers, and principal investigator of the study at Hospital Clinic of Barcelona, stresses: “Advanced HER2+ gastric cancer treatment shows variable response to trastuzumab plus chemotherapy, indicating the need for precise biomarkers.

医学肿瘤学家、上消化道癌症协调员、巴塞罗那医院诊所研究的首席研究员塔马拉·索里博士强调：“晚期HER2+胃癌治疗对曲妥珠单抗加化疗的反应不同，表明需要精确的生物标志物。

HER2DX® not only addresses a crucial unmet need but also explains why HER2-positive gastric cancers often have poorer responses compared to HER2-positive breast cancers. By revealing tumor diversity and expression patterns, the test might guide the development of more effective, personalized treatment strategies.

HER2DX®不仅解决了关键的未满足需求，而且解释了为什么与HER2阳性乳腺癌相比，HER2阳性胃癌的反应往往较差。通过揭示肿瘤的多样性和表达模式，该测试可能会指导开发更有效，个性化的治疗策略。

This insight is crucial as we explore novel anti-HER2 therapies alone or in combination, aiming to improve patient outcomes.”.

这一见解至关重要，因为我们单独或联合探索新型抗HER2疗法，旨在改善患者预后。”。

HER2DX®: beyond breast cancer

HER2DX®：超越乳腺癌

The study utilized the HER2DX® genomic test with a focus on the ERBB2 score to evaluate its association with survival outcomes. The HER2DX® genomic test was evaluated in 60 patients with HER2+ advanced gastric cancer treated at two hospitals in Spain (Hospital Clinic of Barcelona and Hospital General Granollers)..

该研究利用HER2DX®基因组测试，重点是ERBB2评分，以评估其与生存结果的关联。在西班牙两家医院（巴塞罗那医院诊所和格拉诺勒综合医院）治疗的60例HER2+晚期胃癌患者中评估了HER2DX®基因组测试。。

The study highlighted the test's effectiveness, showing a hazard ratio of 0.38 for PFS, indicating a 62% reduction in the risk of progression for patients with high ERBB2 mRNA levels compared to those with low levels. Additionally, the hazard ratio for OS was 0.53, reflecting a 47% reduction in the risk of death for patients in the high ERBB2 mRNA group compared to the low group..

。此外，OS的风险比为0.53，反映出与低组相比，高ERBB2 mRNA组患者的死亡风险降低了47%。。

Comparative Analysis with Breast Cancer

与乳腺癌的对比分析

The study also included a comparative analysis of ERBB2 expression between gastric and breast cancers, revealing generally lower levels of ERBB2 in gastric cancer, including within the HER2 +3 immunohistochemical category. This comparison further highlights the nuanced role of ERBB2 across different cancers and the need for better methods to quantify this target..

该研究还包括对胃癌和乳腺癌之间ERBB2表达的比较分析，揭示了胃癌中ERBB2的水平普遍较低，包括HER2+3免疫组织化学类别。。。

About HER2DX®️

关于HER2DX®️

HER2DX®️ is the world’s first diagnostic test formulated specifically for HER2+ breast cancer. Marketed by REVEAL GENOMICS®️ since January 2022, the HER2DX® is a standardized 27-gene expression test for patients with early-stage HER2+ breast cancer.

HER2DX®是世界上第一个专门针对HER2+乳腺癌制定的诊断测试。自2022年1月以来，由REVEAL GENOMICS®推出的HER2DX®是针对早期HER2+乳腺癌患者的标准化27基因表达测试。

HER2DX®️ is a prognostic and predictive assay based on clinical and genomic data. The test integrates clinical information (i.e., tumor size and nodal status) with biological information tracking immune response, luminal differentiation, tumor cell proliferation, and expression of the HER2 17q12-21 chromosomal amplicon, including the ERBB2 gene..

HER2DX®是基于临床和基因组数据的预后和预测分析。该测试将临床信息（即肿瘤大小和淋巴结状态）与跟踪免疫反应，管腔分化，肿瘤细胞增殖以及HER2 17q12-21染色体扩增子（包括ERBB2基因）表达的生物学信息相结合。。

HER2DX®️ predicts:

HER2DX®预测：

Risk of relapse score (high vs. low): the risk of recurrence in patients with newly diagnosed HER2+ breast cancer.

复发风险评分（高与低）：新诊断的HER2+乳腺癌患者的复发风险。

pCR likelihood score (high vs. medium vs. low): the likelihood of a patient responding to anti-HER2-based treatment before surgery.

pCR可能性评分（高，中，低）：患者在手术前对抗HER2治疗有反应的可能性。

ERBB2 score (high vs. medium vs. low): the quantitative expression of ERBB2 mRNA across HER2-negative, HER2-low and HER2+ breast cancer.

ERBB2评分（高，中，低）：ERBB2 mRNA在HER2阴性，HER2低和HER2+乳腺癌中的定量表达。

About GASTRIC CANCER

关于胃癌

According to the article “The current and future incidence and mortality of gastric cancer in 185 countries, 2020−40: A population-based modeling study” published online by eClinicalMedicine in 2022: “In total, approximately 1.1 million new cases and 770,000 deaths of gastric cancer were estimated in 2020.

根据eClinicalMedicine于2022年在线发表的文章“2020-40年185个国家胃癌的当前和未来发病率和死亡率：基于人群的建模研究”：“2020年，估计总共约有110万新病例和77万胃癌死亡人数。

Incidence rates were on average 2-fold higher in males than females (15.8 and 7.0 per 100,000, respectively) with variation across countries. The annual burden of gastric cancer is predicted to increase to approximately 1.8 million new cases and 1.3 million deaths by 2040.”.

男性的发病率平均比女性高2倍（分别为15.8和7.0/100000），各国之间存在差异。预计到2040年，胃癌的年度负担将增加到大约180万例新病例和130万例死亡。”。

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。。

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

REVEAL GENOMICS，S.L.是巴塞罗那Clínic医院、IDIBAPS、巴塞罗那大学（U.B.）和瓦尔德希布伦肿瘤研究所（VHIO）的附属公司。

REVEAL GENOMICS® and HER2DX® are registered trademarks of REVEAL GENOMICS, S.L.

REVEAL GENOMICS®和HER2DX®是REVEAL GENOMICS，S.L.的注册商标。

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