About Genetic Technologies

Genetic Technologies Limited operates as a molecular diagnostics company that offers predictive testing and assessment tools to help physicians proactively manage women’s health. In June 2020, the company received US Patent No: US 10,683,549, Methods for assessing risk of developing breast cancer. The company is the first company in the world to successfully commercialise a polygenic risk test for breast cancer. The granted patent covers the company’s proprietary panels of single nucleotide polymorphisms (SNPs) and the combination of clinical and phenotypic risk models to create the most comprehensive risk assessment tool on the market: GeneType for Breast Cancer. In May 2019, the company announced the development of two new cancer risk assessment tests branded as GeneType for Colorectal Cancer and GeneType for Breast Cancer. The new breast cancer test provides substantial improvement over its legacy breast cancer test BREVAGenplus, by incorporating multiple additional clinical risk factors. This test will provide healthcare providers and their patients with a 5-year and lifetime risk assessment of the patient developing breast cancer. The colorectal cancer test will provide healthcare providers and their patients a 5-year, 10-year, and lifetime risk assessment of the patient developing colorectal cancer. The company develops other risk assessment tests across a range of diseases, including cardiovascular disease; Type 2 diabetes; prostate cancer; and melanoma. The company successfully launched the first generation BREVAGen test across the U.S. via its U.S. subsidiary Phenogen Sciences Inc. The company marketed BREVAGenplus to healthcare professionals in comprehensive breast health care and imaging centers, as well as to obstetricians/gynecologists (OBGYNs) and breast cancer risk assessment specialists (such as breast surgeons). In May 2019, the company announced that it had developed two new cancer risk assessment tests branded as ‘GeneType for Colorectal Cancer’ and ‘GeneType for Breast Cancer’. The new breast cancer test provides substantial improvement over the company’s legacy breast cancer test BREVAGenplus, by incorporating multiple additional clinical risk factors. This test will provide healthcare providers and their patients with a 5-year and lifetime risk assessment of the patient developing breast cancer. The colorectal cancer test will provide healthcare providers and their patients a 5-year, 10-year, and lifetime risk assessment of the patient developing colorectal cancer. In June 2020, the company received US Patent No: US 10,683,549, Methods for assessing risk of developing breast cancer. The company is the first company in the world to successfully commercialise a polygenic risk test for breast cancer. The granted patent covers the company’s proprietary panels of single nucleotide polymorphisms (SNPs) and the combination of clinical and phenotypic risk models to create the most comprehensive risk assessment tool on the market: GeneType for Breast Cancer. The company’s service testing laboratory in Melbourne became the leading non-Government genetic testing service provider in Australia. The genetic testing services of the company expanded to include at certain times, such as medical testing, animal testing, forensic testing, and plant testing. A strategic alliance with Myriad Genetics Inc. delivered to the company exclusive rights in Australia and New Zealand to perform DNA testing for susceptibility to a range of cancers. In November 2003, the company joined the world-wide genetic testing network GENDIA as the sole reference laboratory for the network in Australia and New Zealand. GENDIA consists of more than 50 laboratories from around the world, each contributing expertise in their respective disciplines to create a network capable of providing more than 2,000 different genetic tests. On April 14, 2010, the company announced that it had acquired certain assets from Perlegen Sciences, Inc. in California, with the main asset being the BREVAGen™ breast cancer risk assessment test (BREVAGen). In addition to the BREVAGen test, the company also acquired a suite of patents valid to 2022 which augment and extend its current non-coding patent portfolio. On June 28, 2010, the company incorporated a wholly owned subsidiary named Phenogen Sciences Inc. in the state of Delaware which commenced selling the BREVAGen™ test in the U.S. marketplace in June 2011. In October 2014, the company released its next generation breast cancer risk assessment test BREVAGenplus. In 2016, the company announced the signing of an exclusive worldwide license agreement with The University of Melbourne for the development and commercialisation of a novel colorectal cancer (CRC) risk assessment test. In 2019, the company signed a three-year collaboration agreement with Translational Genomics Research Institute (TGen). In 2019, the company’s U.S. subsidiary entered into a Research Agreement with Memorial Sloan Kettering Cancer Center of New York and the University of Cambridge. The company entered into an agreement with Shivom in 2018. Shivom is a biotechnology data and analysis company that optimises the way DNA is shared, secured and analysed. Under the agreement, Shivom would provide genetic population data for the development of an Indian market polygenic predictive diabetes test to be developed by the company, as well as future genetic tests it develops, and its CLIA laboratory facilities would be used to develop a regulatory approval strategy for the distribution of completed products. Government Regulations In April 2011, the company obtained certification of its Australian laboratory under the U.S. Clinical Laboratories Improvements Amendments of 1988 (CLIA), as regulated by the Centers for Medicare and Medicaid in Baltimore, Maryland. This certification enables the company to accept and test samples from U.S. residents, and was the culmination of preparations required for the U.S. launch of the company’s BREVAGen test, which occurred in June 2011. Research and Development During the year ended June 30, 2021, the company’s research and development costs were $3,109,383. Regulations The company’s operations are subject to environmental regulations under Australian State legislation. In particular, the company is subject to the requirements of the Environment Protection Act 1993. History Genetic Technologies Limited was founded in 1989. The company was incorporated in 1987.