Gene Business Update

Private Hospital Partnership; Expanded Multi-Test for Australian Market and Commercial Partner for Cancer Clinical Trial - Seite 2

The partnership will be initiated with a 50-patient pilot study to establish workflow and patient reporting, with the study utilising geneType Multi-risk test combined with PGx tests, providing a comprehensive wellness profile for GCPH patients. Patient recruitment has commenced and positive outcomes could enable the rollout of additional Precision Medicine Clinics throughout the Healthscope network. Healthscope is Australia's only national private hospital operation and healthcare provider with a network of 42 hospitals that service every state and territory with approximately 19,000 employees.

geneType granted approval for Pancreatic Cancer, Melanoma, and Atrial Fibrillation in Australia

In September the Company announced that the expanded geneType Multi-Risk Test, to include pancreatic cancer, melanoma, and Atrial Fibrillation (AFib), was approved for sale in Australia by the National Association of Testing Authority (NATA). In March 2023, the expanded test was granted approval for sale by the Centers for Medicare & Medicaid (CMS) for the U.S. market.

The geneType Multi-Risk Test now performs a total of nine individual serious disease risk assessments, all from the one simple saliva sample. The risk assessment panel focuses on Oncology, Cardiovascular and Metabolic diseases, including: Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Prostate Cancer, Melanoma, Colorectal Cancer, Diabetes, Coronary Artery Disease, and Atrial Fibrillation.

The expanded Multi-test panel caters for most ethnicities over the age of 30¹. Each of the new diseases recently approved cause significant mortality and morbidity. According to the Australian Institute of Health and Welfare, in 2023 there will be approximately 10,639 new cases of melanoma, Australia’s third most diagnosed cancer. The estimates for pancreatic cancer are even more dire. In Australia it is estimated that 2,355 people will be diagnosed with pancreatic cancer during 2023 and a staggering 87% of these people will die. For both of these cancers, identifying people at increased risk provides an opportunity for early diagnosis and early intervention, leading to a significant improvement in patient outcomes, extending life expectancy, and saving lives. In the case of AFib, surveys and studies on sections of the Australian population suggest that AFib affects approximately 2% of the general population, equivalent to more than 500,000 people.