Roche Tissue Diagnostics is the largest company in the anatomic pathology industry today offering an FDA-cleared testing package of SEVEN key breast biomarkers for cancer patients. Roche recently announced US Food and Drug Administration approval of the VENTANA PD-L1 (SP142) Assay as the first companion diagnostic to aid in identifying triple-negative breast cancer (TNBC) patients eligible for treatment with the Roche cancer immunotherapy Tecentriq®(atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]). Assessment of PD-L1 biomarker status on tumor-infiltrating immune cells with the assay is essential for identifying those patients most likely to benefit from this treatment. A diagnosis of triple-negative breast cancer means that the three most common proteins associated with breast cancer growth – estrogen receptor, progesterone receptor and HER2/neu – are not expressed on the tumor cells.
A partnership with Roche Tissue Diagnostics means West Cancer Center and Research Institute has access to this newest companion diagnostic testing for patients as well as many other complex assays to aid pathologists in diagnosis.
In a statement by Dr. David Robins, Director of the Pathology and Histology lab at West, “In setting up our laboratory, my very experienced histotechnologists emphatically expressed their preference for Roche’s Ventana BenchMark Ultra as their instrument of choice for immunohistochemistry and in situ hybridization. In their experience with many of the systems available, Ventana stood out from the competition in so many regards. One of the main advantages for a high throughput laboratory such as ours is that the Ventana Benchmark Ultra is fully automated with multiple slide positions, each of which can be customized with regard to temperature and time, thus enabling different assays to run simultaneously. This allows for continuous workflow and improved efficiency within the laboratory. Other advantages over its competition are the exceptional and consistent quality of staining and the impressive number of Roche assays that have been optimized to run on the Ventana platform. With West Cancer Center being a nationally accredited breast cancer program center with high volume and exceptional expertise in treatment of breast cancer, I was also focused on choosing a platform which would give us best quality FDA approved biomarker assays and in situ hybridization capabilities, all of which could be packaged into one system, namely the Ventana BenchMark. We made our choice and have never looked back. Roche, and its regional representatives, have been a pleasure to work with. They are super responsive and helpful in all areas, providing wonderful technical support as well as providing education about its products and their applicability and integration into practice, with the end goal being improved patient care.”
About the VENTANA PD-L1 (SP142) Assay
The VENTANA PD-L1 (SP142) Assay is available on the fully automated BenchMark ULTRA instrument and uses the OptiView DAB IHC Detection Kit with OptiView Amplification Kit. The VENTANA PD-L1 (SP142) Assay performs specific staining of tumor cells and immune cells. The assay was previously approved by the FDA and CE marked for use as a companion diagnostic in urothelial carcinoma (UC) and as a predictive assay in second-line non-small cell lung cancer (NSCLC) with Tecentriq.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and for the treatment of PD-L1 positive, metastatic triple-negative breast cancer.
About West Cancer Center & Research Institute
West Cancer Center & Research Institute is the leader in comprehensive adult cancer care and research in the mid-south, providing the complete continuum of care to more than 30,000 individuals each year. With a 40 year history of clinical excellence and a longstanding commitment to groundbreaking research, West provides patients with a full-spectrum of care; including access to Phase I through Phase III clinical trials. In 2019, West joined OneOncology – a partnership of the nation’s leading community oncology practices with a mission of driving the future of cancer care through a patient-centric, physician-led, data-driven and technology-powered model. To learn more about West Cancer Center, visit: https://westcancercenter.org/.
Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalized healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the tenth consecutive year, Roche has been recognized as the most sustainable company in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI). 3/3 The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2018 employed about 94,000 people worldwide. In 2018, Roche invested CHF 11 billion in R&D and posted sales of CHF 56.8 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com. VENTANA, BENCHMARK and OPTIVIEW are trademarks of Roche. Other product names and trademarks are the property of their respective owners.
 This product is intended for in vitro diagnostic (IVD) use.
 In Switzerland Tecentriq is approved for non-small cell lung cancer only.
 In the US available on the BenchMark ULTRA instrument only
Julie Flanery, Director/Marketing Communications and Business Development
SOURCE West Cancer Center & Research Institute