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Overview of Genetic Technologies (GENE)
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) is a diversified molecular diagnostics company at the forefront of predictive genomics. The company specializes in developing and commercializing advanced genetic testing solutions that integrate DNA-based insights to optimize health outcomes. Operating globally, Genetic Technologies focuses on personalized predictive testing for health, wellness, and serious diseases, with a strong emphasis on oncology, cardiovascular, and metabolic conditions.
Core Business Model
Genetic Technologies operates through a dual revenue model, offering its products and services to both healthcare providers and direct-to-consumer (DTC) markets. Its flagship platform, geneType, provides multi-risk assessment tests that combine genetic and clinical data to deliver actionable insights. The company also markets its EasyDNA brand, which offers a range of genetic tests, including paternity and wellness testing, with significant recurring revenue streams globally. By integrating its proprietary risk stratification platform into healthcare systems, Genetic Technologies enables physicians and individuals to adopt a more preventive approach to disease management.
Product Portfolio and Differentiation
Genetic Technologies' product portfolio includes over 50 risk assessment tests across 14 categories, supported by 25 granted patents and nine pending patents. Its proprietary polygenic risk assessment technology sets it apart in the competitive landscape. Unlike traditional genetic testing, which focuses solely on hereditary factors, the company's solutions incorporate polygenic risk scores to evaluate a broader range of genetic and clinical risk factors. This innovation allows for more comprehensive and personalized risk predictions, particularly in oncology and cardiometabolic diseases.
Market Context and Competitive Landscape
The company operates in the rapidly expanding predictive genomics market, projected to grow at a compound annual growth rate (CAGR) of over 17% and reach $4.6 billion by 2025. Key competitors include established players like 23andMe and Myriad Genetics, as well as emerging startups in the genomics space. Genetic Technologies differentiates itself through its focus on polygenic-integrated risk assessment and its strategic partnerships, such as the collaboration with CancerIQ. This partnership enhances the company's visibility within U.S. healthcare systems and streamlines the integration of its tests into clinical workflows.
Global Reach and Strategic Initiatives
With operations spanning the Asia-Pacific, the United States, and other global markets, Genetic Technologies is committed to scaling its presence. The company employs a capital-light model, leveraging contract-based sales teams to optimize operational efficiency. Its recent initiatives include expanding direct-to-consumer testing programs and integrating its geneType platform into healthcare systems through partnerships. These strategies aim to make its advanced testing solutions more accessible to both clinicians and consumers.
Significance in the Genomics Industry
Genetic Technologies plays a pivotal role in advancing preventive healthcare through genomics. By offering tools that enable early disease risk detection, the company aligns with the broader healthcare industry's shift toward personalized medicine. Its innovative approach to integrating genetic and clinical risk factors positions it as a leader in the field of predictive genomics, contributing to improved health outcomes on a global scale.
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) has been granted US Patent No. 11,031,098 for 'Computer Systems and Methods for Genomic Analysis,' adding to its portfolio of intellectual property. This patent, a significant milestone, enhances the company’s offerings beyond breast cancer risk assessment, including methods for identifying genetic variations linked to diseases and drug responses. The multitest, which will cover over 70% of known mortality and morbidity, is set for release in Q4 2021, showcasing the company's ongoing commitment to advancing genomic health solutions.
Gene's COVID-19 Risk Test has officially launched for sale in the US through its partnership with Infinity BiologiX (IBX). The test predicts COVID-19 severity using genetic and clinical data, aiming to inform treatment options and vaccination priorities for those aged 18 and over. IBX, with its capability to process 100,000 tests per day, will handle production and distribution. This initiative is positioned as a critical tool for employers, governments, and public health entities, helping to manage the pandemic effectively.
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) announced that CEO Simon Morriss will appear on The RedChip Money Report® airing on the Bloomberg Network on May 15, 2021. The interview will cover key updates on the company's lead products, including GeneType for Breast Cancer and GeneType for Colorectal Cancer, as well as the Covid19 Risk Assessment test. Morriss will also discuss future milestones and product commercialization plans, which are critical for investor awareness.
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) announces significant progress in the US commercial launch of its COVID-19 Serious Disease Risk Test in partnership with Infinity BiologiX LLC (IBX). The regulatory submission for the test has been completed, enabling commercial release by the end of May 2021. IBX's telehealth platform will facilitate testing, with a capacity for ~100,000 daily tests. The company aims to expand beyond the US market following necessary regulatory approvals, promising further updates on regional releases.
Genetic Technologies Limited (NASDAQ: GENE) has appointed Michael Tonroe as Chief Financial Officer, effective June 28, 2021. Tonroe brings over 25 years of experience in finance at both private and public companies, including substantial roles in the biotech sector. Chairman Peter Rubinstein expressed confidence that Tonroe's expertise in cross-border financial management will strengthen the company’s leadership team. Tonroe aims to enhance the in-house finance function to support Genetic Technologies' long-term strategy of transitioning to full commercialization in the molecular diagnostics space.
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) announced progress on the US commercial availability of its COVID-19 Serious Disease Risk Test through Infinity BiologiX (IBX).
The validation and data analysis for the test have been completed, with IBX finalizing a technical interface for submission to the Centers for Medicare and Medicaid Services before commercial launch.
IBX, with three labs in New Jersey and Minnesota, is positioned to process over 100,000 tests daily, aiding in the risk assessment of serious COVID-19 cases using genetic and clinical data.
Genetic Technologies Limited (NASDAQ: GENE) has entered a three-year agreement with Infinity BiologiX LLC for co-exclusive production and distribution of its COVID-19 Serious Disease Risk Test in the U.S. Under the deal, IBX will pay a minimum of $2.9 million, including an upfront fee of $50,000, and is required to make minimum payments of $850,000 in the first year and $1 million in each of the subsequent years. IBX's labs can process over 100,000 tests daily, enhancing GTG's test market reach amidst the ongoing pandemic.
Genetic Technologies Limited (NASDAQ: GENE) announced that Dr. George Muchnicki, Chief Medical Officer, will be featured on The RedChip Money Report on Bloomberg TV, airing on February 27. The interview highlights the company’s cancer predictive tools and global market opportunities in genetic testing. Dr. Muchnicki will discuss the upcoming milestones and the potential for Covid-19 serious disease risk testing. The company aims to enhance proactive health management through its risk assessment products, including Germline panel testing for various diseases.
Molecular diagnostics company Genetic Technologies Limited (NASDAQ:GENE) is making strides in developing a Polygenic Risk Score (PRS) test for COVID-19, aimed at assessing the risk of severe disease from the virus. Key updates include the completion of a prototype, a clinical risk model, and a combined risk model. The company has also filed a provisional patent and is in talks for pilot studies. Further development relies on sourcing validation data from Europe. The test is expected to assist in guiding quarantine measures and vaccination prioritization, with an anticipated US release in Q4 2020.
Genetic Technologies Ltd (NASDAQ: GENE) has announced the launch of its GeneType for Breast Cancer Risk Assessment test in the U.S. through the elicity telehealth platform. Priced at $249, the test uses clinical risk factors and Polygenic Risk Scores to estimate breast cancer risk for women without a family history of the disease. The platform is HIPAA-compliant, ensuring secure access to health data. The test aims to empower women with personalized health insights, especially in light of decreased standard check-up rates during COVID-19.