Cerca Biotech’s innovative breast cancer molecular subtyping assay is recognized by leading professional associations in China
BERLIN, GERMANY, January 13, 2025 /EINPresswire.com/ -- Cerca Biotech GmbH (“Cerca Biotech”) and Shuwen Biotech (“Shuwen”) announce that MammaTyper®, Cerca Biotech’s innovative breast cancer molecular subtyping assay, has been included in the “Guidelines for Breast Cancer Diagnosis and Treatment” issued jointly by the Chinese Medical Association (CMA) and the China Anti-Cancer Association (CACA).
MammaTyper® is a standardised multiplex real-time PCR test that quantifies mRNA levels of four essential breast cancer biomarkers (ER, PgR, HER2, and Ki-67) in FFPE tumor biopsy or surgical samples to classify breast cancer into subtypes according to the St Gallen Guideline. Compared to the traditional IHC subtyping, MammaTyper® saves time and labour, and provides test results faster. MammaTyper® provides greater reproducibility and precision, and offers more accurate breast classification which results in more effective treatment and improved patient outcome which has been effectively demonstrated in more than 20 clinical studies. In addition, recent studies have shown that MammaTyper® potentially offers a better alternative to HER2 testing to guide anti-HER2 therapies including Herceptin and the newer HER2-ADC drugs. MammaTyper can also accurately predict low risk results by OncoType Dx testing, and may be used as a locally available low-cost pre-screening for OncoType Dx.
MammaTyper® is an in vitro diagnostic kit CE marked in Europe and approved by Chinese NMPA. It is commercially available in over 50 countries. In China, MammaTyper® is being distributed by Shuwen Biotech and available in most major hospitals treating breast cancer patients.
Commenting on the guideline release Jay Z. Zhang, MS, JD, Executive Chairman of Shuwen Biotech and Managing Director of Cerca Biotech stated, “We welcome the update in the Chinese guideline from the leading professional associations. We hope patients will benefit from MammaTyper® through its wide availability, implementation and recognition by leading experts and professional associations.”
About Cerca Biotech:
Cerca Biotech is adiagnostic company based in Germany focused on bringing novel and innovative diagnostic products to the oncology and women’s health market. We strive to introduce the best tests to meet the unmet clinical needs at an affordable cost, with clinical accuracy and rapid results as our focus. Utilising a combination of experienced distributors and direct sales Cerca Biotech has a commercial reach from Germany through the Nordics and Eastern Europe to the Middle East, Africa, India and beyond. Our team comprises of highly experienced commercial, technical and clinical experts in the field of IVD, allowing rapid deployment of novel technologies with a ‘get it right first time’ strategy. Cerca Biotech is an affiliated subsidiary of Shuwen Biotech. For more information, please visit: www.cercabiotech.com.
About Shuwen Biotech
Shuwen Biotech is an integrated women’s health diagnostic company with offices in China and Germany. Shuwen houses an experienced development and regulatory team, GMP/ISO13485-certified IVD manufacturing facilities, and CAP-accredited central labs, all in line with global standards to continue to deliver transformational products and services to its customers globally and open new possibilities in the advancement of health. Founded on the principles of innovation, patent protection, and international collaboration, Shuwen established strategic partnerships with leading academic and commercial institutions to commercialize first-in-class diagnostic technologies and patents, and has developed and commercialized a range of novel diagnostics in the fields of cancer and women’s health. Shuwen has also developed quality companion diagnostics and provided central lab biomarker testing services to leading pharmaceutical developers and hospitals. Innovative diagnostic products in women’s health are marketed throughout China and internationally in more than 50 countries. For more information, please visit https://www.shuwendx.com/en/home/.
For further information:
Richard Hughes, info@cercabiotech.com
Jay Z. Zhang, info@shuwendx.com
Jay Z. Zhang
Cerca Biotech GmbH and Shuwen Biotech Co. Ltd.
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