MELBOURNE, Australia, Aug. 30, 2022 (GLOBE NEWSWIRE) — Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GENE”), a global leader in guideline-based genomics-based testing in the health and well-being and critical illness is pleased to publish its annual results for the year ended June 30, 2022.
We’ve had an exciting 12 months focusing on our journey to market. We now have the most comprehensive portfolio of genetic tests available for people and animals. In addition to our patented geneType polygenic risk tests, our portfolio includes pharmacogenomics, non-invasive prenatal testing (NIPT), carrier screening, oncogenetic diseases and companion animal care.
This year, we have moved from an R&D organization with a polygenic risk test to an organization whose revenues are anchored in 3 brands: geneType, EasyDNA and AffinityDNA.
Highlighting our business progress, the company reports revenue for the year ended June 30, 2022 of A$6.674 million, an increase of 5,536% over 2021.
This revenue was supported by our acquisition of EasyDNA in August 2021. In July 2022, we announced the acquisition of AffinityDNA, which will provide additional opportunities for core revenue growth in new markets and new canals.
Our patented multi-risk geneType test is a pioneer in risk assessment by combining genetic and clinical risk models with cutting-edge research. We are leading a personalized healthcare revolution. This first-in-class test wallet can predict a person’s risk by up to 70%1 annual mortality and morbidity before onset. This allows us to make material progress in our mission to unlock personalized preventative healthcare. We transform the conversation from a one-size-fits-all model to a truly personalized one, giving patients and physicians the insights they need to proactively develop and manage patient journeys based on their own risk.
In October 2021, we launched a global relaunch of the geneType brand, followed by the commercialization of the geneType multi-risk test in February 2022. The multi-risk test provides six risk assessments in a single test covering breast cancer, colorectal cancer, cancer prostate cancer, ovarian cancer, coronary artery disease and type 2 diabetes. As noted earlier, these diseases together account for approximately 70% of all annual pre-onset morbidity.
To support the launch of geneType and drive adoption of the tests, we have undertaken a number of strategic initiatives.
In the US, we have launched a number of key strategies, with the appointment of an experienced vice president of business development, John Haslet. John has considerable experience in building sales networks for the geneType brand in three key sales channels, namely:
- Independent Physician Networks (IDN)
- Concierge Medicine
- Payment systems
An important element in generating revenue through these channels is obtaining reimbursement for geneType testing. Our first step to obtaining reimbursement was completed earlier this year with the finalization of a Budget Impact Model (BIM). BIM demonstrated significant improvement in health and economic benefits and also improved patient outcomes when the geneType breast cancer risk assessment test was implemented for eligible patients. The independently developed and validated BIM has been prepared by our ALVA10 consultants and has the following advantages:
- US payers could see savings of up to US$1.4 billion or 3.6% per year
- 69% to 74% overall increase in the number of women getting tested
- 6.8% to 9.2% improvement in additional screening frequency
- 14.8% – 8.8% decrease in interval cancers
- 57% to 67% improvement in early cancer detection
The importance of these results cannot be underestimated, they provide a very compelling case for US payers to reimburse the geneType breast cancer risk assessment test. We now have over 10 active discussions with payer groups in an effort to gain coverage for the test.
Reimbursement of our geneType test would be a “game changer” event for GENE. This would see the test widely adopted in the world’s largest healthcare market. Additionally, this initiative will provide a pathway for other tests in the multi-hazard testing portfolio to also be reimbursed.
In Australia, we have appointed a virtual sales team supported by Hahn Health, now part of the global DKSH group, to promote geneType to Australian physicians. This approach has been very effective in establishing our geneType Hub concept, integrating more than 40 practices (at the end of August 2022). We have further expanded the geneType Hub strategy through a partnership with leading specialist in obstetrics and genecology, Associate Professor Charles Siles. The partnership provides GENE with immediate access to more than 1,000 referring physicians and 15,000 patients each year. In addition, the partnership also provides GENE with a significant opportunity in expanding Carrier and NIPT testing.
In May 2022, we launched the new EasyDNA brand and started rebuilding the websites. Our team continued to search around the world for unique growth initiatives and launched a number towards the end of the year:
- Carriage testing and non-invasive prenatal testing (NIPT) in Europe
- Partnership in India with stud farms extending paternity to the equine sector
- DNA storage solution at GENE’s NATA accredited facility
Our science team has been very busy. In the past year, the company has obtained 10 granted patents and 5 new provisional patents filed. The team has four publications published in peer-reviewed journals and three other articles submitted and under review. Additionally, we continue to work on optimizing our existing tests. An important example of optimizing our existing test was a 200,000 participant study that we presented late last year at the San Antonio Breast Cancer Symposium. This work validated the geneType breast cancer risk assessment test model with an expanded panel of 313 single nucleotide polymorphisms (SNPs). In addition, the scientific team worked on increasing the number of diseases that the multi-risk test can predict.
In the coming year, we plan to add melanoma, type 2 diabetes and pancreatic cancer to the portfolio.
The quality of the work undertaken by Dr. Allman’s team is evidenced by the strength of the collaborations that GENE has built, including:
- Professor Bernard Rosner. Channing Division of Network Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, USA – Principal Investigator of the Nurses’ Health Study (international expert in breast cancer biostatistics and epidemiology)
- Professor Graham Colditz. Deputy Director, Institute of Public Health. Washington University School of Medicine, St. Louis, Missouri (International expert in breast cancer biostatistics and epidemiology)
- Professor Jon Emery, Professor of Primary Care Cancer Research at the University of Melbourne and the Victorian Comprehensive Cancer Center
- Professor John Hopper, Professorial Fellow at the Center for Epidemiology and Biostatistics, School of Global Population Health, University of Melbourne
The Australian lab has expanded its capabilities by gaining NATA accreditation for six polygenetic risk score tests and a new GSA pipeline. The lab has also received US CMS – CLIA certification for the same six polygenetic risk tests and the GSA pipeline. Finally, our regulatory team received the ARTG notification from the Therapeutic Goods Administration (TGA) for the geneType Multi-Risk test.
Over the coming year, we are focusing on four key areas:
- Drive revenue and commercialization of the geneType test suite, expanding the launch of the described initiatives
- Driving the growth of the EasyDNA and AffinityDNA brands with new tests, new markets and new channels
- Continue to demonstrate the clinical utility of geneType tests with our highly committed scientific and medical advisors and our strong patent and publication strategy
- A focus on innovation with the establishment and evaluation of new divisions
We have the most comprehensive testing portfolio available; we now offer more than 50 tests in 14 categories with future revenue anchored in our three brands; geneType, EasyDNA and affinity DNA.
We would like to thank you for your continued support. Our company is uniquely positioned to seize a multi-billion dollar opportunity in a highly visible and rapidly growing market.
Cleared for publication by the Board of Genetic Technologies Limited
About Genetic Technologies Limited
Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE). A global leader in genomics-based testing for health, wellness and critical illness through its geneType, EasyDNA and AffinityDNA brands. GENE leads the most comprehensive portfolio of genetic testing, from carrier screening and NIPT to advanced predictive testing and assessment tools to help physicians improve health outcomes for people around the world. The Company’s Polygenic Risk Scores (PRS) platform is a proprietary risk stratification platform developed over the past decade integrating clinical and genetic risks and providing actionable results to physicians and individuals. World leader in risk prediction in oncological, cardiovascular and metabolic diseases. Genetic Technologies continues to develop a line of risk assessment products. For more information, visit www.genetype.com
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1 https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm
