Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE IVDR approval for two label expansions for its VENTANA® HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx* assay. HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy. .

罗氏（SIX：RO，ROG；OTCQX：RHHBY）今天宣布，其VENTANA® HER2（4B5）兔单克隆初级抗体RxDx*检测获得了CE IVDR批准，用于两项标签扩展。HER2是一种在多种癌症中表达的受体蛋白，可作为预测性生物标志物，帮助确定患者是否会对HER2靶向治疗产生反应。

The VENTANA HER2 (4B5) test is the first and only companion diagnostic approved to identify patients with HR-positive metastatic breast cancer that are HER2-ultralow. These patients may be eligible for treatment with ENHERTU® (trastuzumab deruxtecan), a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.

VENTANA HER2 (4B5) 检测是首个且唯一获批的伴随诊断工具，用于识别 HER2 极低水平的 HR 阳性转移性乳腺癌患者。这些患者可能符合接受 ENHERTU®（曲妥珠单抗 deruxtecan）治疗的条件，ENHERTU® 是一种专门设计的 HER2 靶向抗体药物偶联物 (ADC)，由第一三共发现，并由第一三共和阿斯利康共同开发和商业化。

In addition, this test is now the first and only companion diagnostic to aid in the assessment of HER2-positive status to identify biliary tract cancer patients with an immunohistochemistry score of 3+ who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA® (zanidatamab-hrii)..

此外，这项检测现在是首个且唯一的辅助诊断工具，用于帮助评估HER2阳性状态，以识别免疫组化评分为3+的胆道癌患者，这些患者符合接受Jazz Pharmaceuticals公司ZIIHERA®（扎尼达单抗-hrii）治疗的条件。

'This is about creating new options for patients facing some of the toughest cancers,' said Jill German, Head of Pathology Lab at Roche Diagnostics. 'Our understanding of HER2 is rapidly evolving, and this expanded approval ensures our diagnostics are leading the way. We're enabling clinicians to unlock personalized, life-altering treatments for patients who urgently need them.'.

“这是为了给那些面临最棘手癌症的患者创造新的选择，”罗氏诊断病理实验室负责人吉尔·杰曼表示。“我们对HER2的理解正在迅速发展，这一扩展批准确保我们的诊断方法走在前沿。我们正在使临床医生能够为迫切需要的患者解锁个性化的、改变生命的治疗方案。”

Advancing Science in HER2-ultralow Breast Cancer Â

在HER2超低乳腺癌中推进科学

In Europe this year, more than 564,000 people will be diagnosed with breast cancer, and more than 145,000 are estimated to die from the disease.

今年在欧洲，将有超过 564,000 人被诊断出患有乳腺癌，并且据估计超过 145,000 人将死于该疾病。

  Metastatic breast cancer incidence is rising in younger populations and is the leading cause of breast cancer related death.

转移性乳腺癌的发病率在年轻人群中正在上升，并且是乳腺癌相关死亡的主要原因。

HER2 interpretation in breast cancer continues to evolve beyond the traditional 'positive' or 'negative' classifications. The test now enables the identification of a new patient population designated as 'HER2-ultralow,' referring to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category.

乳腺癌中的HER2解读持续演进，超越了传统的“阳性”或“阴性”分类。该检测现在能够识别一个新患者群体，被定义为“HER2极低”，指那些HER2表达水平非常低的患者，甚至低于现有的HER2低表达类别。

Approximately 20-25 percent of hormone receptor (HR)-positive, HER2-negative breast cancer patients may be considered HER2-ultralow..

大约20%-25%的激素受体（HR）阳性、HER2阴性的乳腺癌患者可能被视为HER2超低表达。

These patients may now be eligible for ENHERTU.

这些患者现在可能有资格接受ENHERTU治疗。

The VENTANA HER2 (4B5) test was used in the DESTINY-Breast06 trial,

VENTANA HER2 (4B5) 检测在 DESTINY-Breast06 试验中使用，

which demonstrated a significant improvement in progression-free survival with ENHERTU compared to standard of care chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer.

与标准护理化疗相比，ENHERTU在HER2低表达和HER2超低表达的转移性乳腺癌患者中展示了无进展生存期的显著改善。

Addressing Unmet Needs in Biliary Tract Cancer Â

满足胆道癌未满足的需求

In Europe, the incidence of biliary tract cancer (BTC) and mortality rates from the disease have been increasing in the past few decades.

在欧洲，过去几十年胆道癌 (BTC) 的发病率和死亡率一直在上升。

  BTC is often diagnosed at an advanced stage, and patients currently have very few treatment options.

BTC通常在晚期才被诊断出来，目前患者可选择的治疗方法很少。

The prognosis for these patients is generally poor.

这些患者的预后通常较差。

The VENTANA HER2 (4B5) test is now approved to identify BTC patients with HER2-positive status who may be eligible for treatment with ZIIHERA.

VENTANA HER2 (4B5) 检测现已获批用于识别 HER2 阳性的 BTC 患者，这些患者可能符合接受 ZIIHERA 治疗的条件。

About VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx

关于VENTANA HER2（4B5）兔单克隆初级抗体RxDx

The VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx assay delivers timely, clear and reliable results, driving diagnostic certainty and enabling therapeutic decisions that can lead to better outcomes for patients.  Previously indicated as an aid to identify certain breast cancer patients eligible for HER2-targeted treatment with Herceptin®, KADCYLA®, PERJETA®, or ENHERTU,.

VENTANA HER2 (4B5) 兔单克隆初级抗体 RxDx 检测试剂提供了及时、清晰和可靠的结果，推动诊断的确定性，并帮助制定可能为患者带来更好结果的治疗决策。此前，该检测被指定用于帮助识别符合 HER2 靶向治疗条件的某些乳腺癌患者，适用的药物包括赫赛汀®、KADCYLA®、PERJETA® 或 ENHERTU®。

and gastric cancer patients eligible for treatment with Herceptin, the test is used in combination with the fully automated VENTANA BenchMark slide staining instrument.

并且胃癌患者有资格接受赫赛汀治疗，该测试与全自动VENTANA BenchMark玻片染色仪器结合使用。

The assay standardizes all immunohistochemistry (IHC) processes from baking through staining, and reduces the possibility of human error.

该测定法规范了从烘烤到染色的所有免疫组织化学 (IHC) 流程，并减少了人为错误的可能性。

It also minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods. The HER2 (4B5) clone achieves consistently high proficiency assessment scores compared to other clones

它还最大限度地减少了因个别试剂稀释和在手工及半自动IHC方法中发现的其他过程而产生的固有变异性。HER2（4B5）克隆与其他克隆相比，始终获得较高的熟练度评估分数。

and demonstrates high concordance with HER2 FISH,

与HER2 FISH表现出高度一致性，

empowering laboratories to employ the most widely adopted and reliable HER2 IHC primary antibody.

赋能实验室采用最广泛使用且可靠的HER2 IHC一抗。

For more information about the portfolio, please visit the Roche Diagnostics Pathology Lab companion diagnostics page.

有关该产品组合的更多信息，请访问罗氏诊断病理实验室伴随诊断页面。

About Roche

关于罗氏

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world.

罗氏公司成立于1896年，总部位于瑞士巴塞尔，是最早生产品牌药品的工业制造商之一。如今，罗氏已发展成为全球最大的生物技术公司，并在体外诊断领域处于全球领先地位。公司致力于追求科学卓越，通过发现和开发药物及诊断工具来改善和拯救世界各地人们的生命。

We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice..

我们是个性化医疗的先驱，希望进一步改变医疗服务的提供方式，以产生更大的影响。为了给每个人提供最好的护理，我们与许多利益相关者合作，将我们在诊断和制药领域的优势与临床实践中的数据洞察相结合。

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. .

一百二十五年以来，可持续发展一直是罗氏业务的重要组成部分。作为一家以科学为驱动的公司，我们对社会的最大贡献在于开发创新药物和诊断工具，帮助人们过上更健康的生活。罗氏致力于科学基础目标倡议和可持续市场倡议，力争在 2045 年前实现净零排放。

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

Genentech（美国基因泰克公司）是罗氏集团的全资成员。罗氏是日本中外制药公司的控股股东。