Sienna Cancer Diagnostics Ltd, (ASX:SDX) (“Sienna” or “the Company”), a medical technology company developing and commercialising innovative cancer related tests, is pleased to announce it has appointed Shaanxi GaoYuan In Vitro Diagnostic Reagents Co. (“GaoYuan”) as the Company’s exclusive distribution partner for mainland China.
Melbourne, Australia, 7 August 2018: Sienna Cancer Diagnostics Ltd, (ASX:SDX) (“Sienna” or “the Company”), a medical technology company developing and commercialising innovative cancer related tests, is pleased to announce it has appointed Shaanxi GaoYuan In Vitro Diagnostic Reagents Co. (“GaoYuan”) as the Company’s exclusive distribution partner for mainland China.
The distribution agreement for mainland China is a milestone in Sienna’s geographical expansion strategy. The agreement gives GaoYuan the exclusive right to sell Sienna’s in-vitro diagnostic hTERT test to pathology labs where it will be used as an adjunct to urine cytology, assisting pathologists and urologists in the diagnosis of bladder cancer.
China has a population of approximately 1.4 billion people and is one of the fastest growing consumers of IVD products globally. GaoYuan has significant reach across China through both direct sales and distribution networks, both of which are key sales channels for the market.
Matthew Hoskin, CEO of Sienna Cancer Diagnostics, commented: “This milestone agreement follows months of due diligence by both parties. We have been very deliberate in selecting a partner which has the adequate size, reach and capability to penetrate the Chinese market effectively, but also one that regards Sienna’s test as a real growth opportunity for the Company, and will put strong promotional support behind our product.”
Prior to sales commencing, the product must first be approved and registered with the China Food and Drug Administration (CFDA). The process will be led and managed by GaoYuan with support provided by Sienna. The timeframe is dependent on the medical device classification type selected by the CFDA and will be announced separately upon commencement of the process.
While regulatory approval is being sought, Sienna will commence training the GaoYuan sales, marketing and technical support staff so the product launch within mainland China can commence as soon as registration is complete.
Mr Wenguang Yan, General Manager of GaoYuan said: “GaoYuan has significant experience selling invitro diagnostic cancer tests to pathology laboratories across China, including our own biomarker-based test for cervical cancer. We understand the needs of this market, have well-established relationships to help drive uptake, and have a skilled team in place to promote, sell, and support this new product. The market opportunity for this product in China is significant, and GaoYuan is pleased to be introducing a product that adds real clinical value to the diagnostic process which will help patients, while at the same time creating growth for our business.”
ENDS.
For further information, please contact: Matthew Hoskin, CEO Sienna Cancer Diagnostics Ltd mhoskin@siennadiagnostics.com.au +61 3 8288 2141
Kyahn Williamson or Lauren Nowak WE Buchan sienna@we-buchan.com +61 3 8866 1200
About Sienna Cancer Diagnostics Sienna Cancer Diagnostics Ltd. is an Australian medical technology company, with operations in the United States, Europe and Australia. Sienna’s strengths lie in identifying novel technologies then developing and commercialising them to satisfy an unmet clinical / market need. The Company has demonstrated the utility of its product with the help of its global clinical partners. Sienna’s primary platform is the detection of the biomarker telomerase, which is found in nearly all epithelial cancers, and was the subject of a Nobel Prize in 2009. Telomerase is well recognised for being used by 85% of cancers to enable immortal cell replication. The FDA listing of Sienna’s first IVD in the United States, and CE marking / IVD registration in Europe and Australia, means the assay can be used for clinical diagnostic purposes by pathology laboratories. Clinical pathology laboratories in those regions may purchase the product for use as an in vitro diagnostic test for the presence of hTERT, a component of telomerase. About Shaanxi GaoYuan In Vitro Reagents Co. Shaanxi GaoYuan Medical Equipment Service Co., Ltd., founded in 1999, is presently centred on the development and production of new technology related to cancer screening. The initial scope of business was focused on selling capital equipment and laboratory reagents, in addition to the development and production of new technologies. In response to the rapid growth of the reagent business and the desire to specialize, Shaanxi GaoYuan In-vitro Diagnostic Reagent Co., Ltd., also known as GaoYuan, was formed in 2010. GaoYuan has been providing in-vitro diagnostic products to the Chinese market since 2010. During this time, GaoYuan has successfully introduced advanced screening technology for prenatal conditions, newborn diseases, gynaecological cancers and molecular diagnostics.
Forward Looking Statements This announcement may contain forward-looking statements, which include all matters that are not historical facts. These forward-looking statements speak only as at the date of this announcement. These statements, by their nature, are subject to a number of known and unknown risks and uncertainties that could cause the actual results, performances and achievements to differ materially from any expected future results, performance or achievements expressed or implied by forward-looking statements. Without limitation, indications of, and guidance on, future earnings and financial position and performance are examples of forward-looking statements. No representation, warranty or assurance (express or implied) is given or made by Sienna that the forward-looking statements contained in this announcement are accurate, complete, reliable, or adequate or that they will be achieved or prove to be correct. Except for any statutory liability which cannot be excluded, each of Sienna, its related companies and their respective directors, employees and advisers expressly disclaim any responsibility for the accuracy or completeness of the forward-looking statements and exclude all liability whatsoever (including negligence) for any direct or indirect loss or damage which may be suffered by any person as a consequence of any information in this presentation or any error or omission therefrom
