Genetic Technologies Limited
Quarterly Activities Report and Appendix 4C of the ASX Listing Rules for the quarter ended 30 June 2017 - Seite 4
Excluding skin cancers, CRC is the third most common cancer diagnosed in both men and women in the U.S. representing an overall lifetime risk of about 1 in 20 (5%). CRC is also the third leading cause of cancer-related deaths in the U.S. when men and women are considered separately, and the second leading cause when both are combined. As with breast cancer, early diagnosis is key as the majority of CRC cases are preventable by early detection and removal of precancerous polyps. According to the American Cancer Society, when diagnosed at an early stage (before the disease has spread outside the colon), the relative 5-year survival rate for CRC is 92% and 87% for rectal cancer, while the respective survival rate for late stage (metastatic) disease is much lower, at 11% and 12%, respectively.
More detail regarding colorectal cancer risk assessment test can be found in the Company's announcement dated 29 November 2016.
Investigator initiated research Agreement with The Ohio State University
On 15 June 2017, Genetic Technologies executed a Clinical Study Agreement with The Ohio State University, Technology Commercialisation Office and Division of Human Genetics. This is an "investigator-initiated" study in which Genetic Technologies was approached to be the collaborating partner, reflecting the growing awareness of the Company's expertise in SNP-based risk assessment.
The terms and conditions of the Agreement are confidential however; Genetic Technologies will supply novel SNP-based genotyping for a clinical research study, through its CLIA laboratory facility, on a fee for service basis. The Company will be responsible for the development and validation of the new assay, although the fundamental technology is similar to the BREVAGenplus test and will fit synergistically into the Company's existing infrastructure and processes. Importantly, if the first phase of the study is successful, several other major genetics centres in the U.S. have expressed an interest in joining the study. This collaborative study provides two tangible benefits for the Company:
(i) engagement and collaboration with high profile cancer genetics researchers in the U.S. who are at the forefront of risk assessment research; and
(ii) the resulting data can be used to inform the design of future pipeline products
Lesen Sie auch
As with the exclusive worldwide license agreement with The University of Melbourne for the development and commercialisation of a novel colorectal cancer risk assessment test, this Agreement represents another milestone for the Company as it seeks to diversify its product pipeline and become a key player in the SNP-based cancer risk assessment landscape.
Clinical Studies and Peer-Review Publication Update
The Company's transition from a traditional reimbursement system through insurance providers, to a direct patient self-pay program has enabled the de-emphasis of clinical utility studies designed to achieve reimbursement coverage through the private insurers. With the realignment of the product to USPSTF guidelines on risk reduction, the output of two questionnaire-based clinical studies, which commenced in Q4 FY16, is being re-evaluated in light of the product change, and is likely to be combined with data from other studies for publication purposes.
Signed on behalf of Genetic Technologies Limited
Date: 27 July, 2017
Eutillio Buccilli
Executive Director and Chief Executive Officer
FOR FURTHER INFORMATION PLEASE CONTACT
Mr. Eutillio Buccilli
Executive Director & Chief Executive Officer
Genetic Technologies Limited
+ 61 3 8412 7050
Jamien Jones (USA)
Blueprint Life Science Group
+1 (415) 375 3340, Ext. 5