Highlights:
- Solid cash balance of
A$13.5 million and increased customer receipts ofA$1.8 million further extending runway for growth - ‘One company two brands’ approach leverages EasyDNA acquisition with launch of the Multi-Test product
- Multi-Test technical validation complete and submitted to NATA1 and CMS2 for final regulatory approval ahead of the commercial release
- Multi-Test to address a burgeoning market determining personal risk of developing a range of serious diseases including:
- breast cancer
- colorectal cancer
- ovarian cancer
- prostate cancer
- coronary artery disease
- type 2 diabetes
- US patent application for novel geneType COVID-19 Risk Test has been accepted and cross validation study completed in independent cohort confirming test performance and utility
- Study of 200,000 participants presented at 2021 San Antonio Breast Cancer Symposium validating the risk model with an expanded panel of 313 Single Nucleotide Polymorphisms (SNPs)
- EasyDNA distribution network provides access to a significant addressable market with 70 websites in 40 countries and further engagement with IBX on the COVID-19 Risk Test
- COVID-19 Risk Test – expanded US patient access with new partnership agreement signed with 1Health and IBX. Cross validation study completed, independent cohort confirms test performance and utility. Emergence of new strains of COVID-19, such as Omicron, highlight the importance and utility of GENE’s COVID-19 Risk Test.
EasyDNA Acquisition and geneType Brand Launch
GENE announced the acquisition of EasyDNA in
Overall, the Company is in a strong position with a portfolio of high-quality products both in the market and under development and a substantial international platform for the distribution of the Direct-to-Consumer product base via EasyDNA.
As part of the EasyDNA integration, the Company announced the launch of the geneType rebrand in
Total cash receipts for the quarter from EasyDNA were
Commercialization and Product Overview
The Company’s strategy to commence commercialization and enhance the product distribution network is well underway. Key avenues for commercialization of launched products currently include the consumer-initiated testing and online sales and marketing platform (CIT) available in
Core products for release include GENE’s geneType for Breast Cancer, geneType for Colorectal Cancer and the COVID-19 Risk Test with the commercial release of the Company’s Multi-Test to cover both Colorectal Cancer and Breast Cancer in addition to Prostate Cancer, Ovarian Cancer, Coronary Artery Disease and Type 2 Diabetes.
GENE now has distribution coverage in
Multi-Test Product Commercial Release
In late
The phase one launch is the culmination of 10+ years of research and development and include Breast Cancer, Colorectal Cancer, Ovarian Cancer, Prostate Cancer, Coronary Artery Disease and Type 2 diabetes. The Company is now focused on finalizing commercial distribution opportunities via our EasyDNA brand and through our existing partner network with IBX, 1 Health and Vitagene.
The direct-to-consumer genetic testing market represents a significant growth opportunity for GENE, the total worldwide market is expected to grow from
Of particular relevance to GENE’s Multi-Test development is the emergence of Precision Medicine and its ability to classify individuals into subpopulations that differ in their susceptibility to a particular disease. GENE’s Risk Assessment Tests are an important part of eliminating the traditional “one size fits all” approach, enabling preventive or therapeutic measures to be concentrated on patients who will gain the most benefit, significantly improving patient outcomes and health economics.
COVID-19 Risk Test
In
1health is a leading US-based cloud platform service provider for diagnostic test management. 1health has built infrastructure that helps laboratories, such as IBX and their customers, connect patients to testing and care. 1health’s services will be managed in partnership with IBX under our three-year co-exclusive licence agreement previously announced on
The Company has continued to expand and develop the geneType COVID-19 Risk Test, having recently completed a cross-validation study on a European data set confirming the test performance metrics. A paper describing the study has now been submitted to a peer-reviewed journal and will be released upon publication. The emergence of the Omicron variant underscores the importance of being able to identify those patients, whether vaccinated or not, who are at greater risk of developing severe disease.
The geneType COVID-19 Risk Test is designed to predict disease severity in people aged 18 and older, using genetic and clinical information providing a risk score that can be used to understand a person’s risk of contracting a serious case of COVID-19. In addition, employers, governments, and other public health entities may use the data to make informed decisions about disease risk, treatment options, and importantly guiding vaccination and booster priorities. According to the
Research and Publications
Over the quarter, the Company has continued to invest in its product development supporting a self-funded study in collaboration with the
In
The Company is pleased to report a further peer-reviewed research publication entitled “Ability of known colorectal cancer susceptibility SNPs to predict colorectal cancer risk: A cohort study within the
The study describes how the addition of a polygenic risk score to a family history model improves the stratification and discriminatory performance of both 10 year and full lifetime risk using a prospective population-based cohort within the
Current screening guidelines in the
Outlook
The Company remains focused on the commercialization opportunities for the Multi-Test, continued leveraging the EasyDNA brand and product suite to grow the revenue base, further investment in R&D to enhance our Multi-Test offering and COVID-19 Risk Test and continuing to remain at the cutting edge of genetic testing and preventative health.
Commenting on the forward outlook,
Investor Webinar
The Company will provide an investor webinar to discuss the quarterly results. To register please follow the link below.
Date:
Time:
Registration Link: https://us02web.zoom.us/webinar/register/WN_YLLED0yxRHGiDMX6htX8jg
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About
For more information, please visit www.genetype.com
Forward-Looking Statements
This press release may contain forward-looking statements about the Company's expectations, beliefs or intentions regarding, among other things, statements regarding the expected use of proceeds. In addition, from time to time, the Company or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as "believe," "expect," "intend," "plan," "may," "should" or "anticipate" or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by the Company with the
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