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Genetic Technologies Expands Operational Capacity in North America

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Genetic Technologies (NASDAQ: GENE) has launched testing operations in the U.S. for its geneType genetic risk assessment product series. Utilizing the advanced facilities of Gene by Gene in Houston, the company aims to process up to 25,000 tests per month, enhancing operational capacity and reducing turnaround times for North American samples. This expansion is bolstered by a distribution agreement with Stayhealthy, expected to drive growth across North America. GeneType's tests, which are non-invasive and saliva-based, cover risks for nine diseases, including metabolic, cardiovascular, and oncological conditions. The collaboration aims to meet rising demand for personalized health information.

Positive
  • GeneType tests will now be processed at Gene by Gene, enhancing operational capacity to 25,000 tests per month.
  • Gene by Gene's central U.S. location will reduce sample turnaround times.
  • GeneType's non-invasive, saliva-based tests are clinically validated and regulatory approved.
  • Partnership with Stayhealthy provides access to up to 1.5 million users and over 200 million U.S. email addresses.
  • Stayhealthy's distribution channels include employee health benefits and online pharmacy, broadening consumer reach.
Negative
  • No specific financial figures or revenue projections provided in the PR.
  • Potential risks associated with scaling operations quickly and maintaining quality control.
  • Increased competition in the genetic testing market could impact growth.

Insights

GeneType's expansion represents a significant milestone in the field of personalized genetics. By teaming up with a highly accredited lab like Gene by Gene, GTG is enhancing its operational capabilities to process up to 25,000 tests per month. This capacity increase means a more rapid turnaround for patients, which is critical in disease risk assessment and management. The location in the central US further shortens the timeframe for sample processing, thereby improving the overall efficiency of the testing process.

The integration of Polygenic Risk Scores (PRS) with clinical risk models provides a more comprehensive view of an individual’s disease susceptibility. This approach is innovative as it blends genetic data with clinical parameters to deliver actionable health insights. It's worth noting that GTG’s suite of tests covers diseases responsible for 70% of annual mortality and morbidities, making their application highly relevant for public health.

Such advancements reflect the growing trend towards personalized medicine, where treatments and preventive measures are tailored to individual genetic profiles. This collaboration could drive significant growth for GTG, particularly as public awareness and demand for genetic testing continue to rise. However, it's essential to monitor regulatory compliance and data privacy considerations, which are critical in the healthcare sector.

This expansion through collaboration with Gene by Gene and Stayhealthy significantly boosts GTG's potential in the North American market. The ability to process up to 25,000 tests per month underlines substantial revenue potential. Additionally, Stayhealthy's established distribution network, including a consumer base with access to 1.5 million users and a B2B2C model, offers extensive market reach.

From a financial perspective, this operational boost could lead to higher revenue streams and improved margins due to economies of scale. However, investors should be aware of the financial commitments involved in scaling operations and the associated risks. It's important to monitor GTG's quarterly earnings reports to understand the financial impact better and how these expansions translate into actual revenue growth.

Moreover, regulatory approvals for new tests in development could provide a competitive edge and open new revenue channels. The key takeaway for investors is to focus on the company's ability to maintain growth momentum and manage operational costs effectively.

Global leader in personalized predictive genetics launches testing operations for geneType disease risk assessments at US based, world-leading genetic laboratory, Gene by Gene

CHARLOTTE, N.C., June 18, 2024 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a global leader in genomics-based tests in health, wellness and serious disease, today announces the start of testing operations in the United States for its revolutionary geneType™ genetic risk assessment product series.

GeneType’s multi-patented, clinically validated tests will now be performed by Gene by Gene, a premier specialty genetic laboratory based in Houston, Texas, a state-of-the-art, highly accredited laboratory (CLIA, CAP, AABB and CDPH licensed). Gene by Gene’s ability to process up to 25,000 tests per month greatly increases geneType’s operational capacity in North America. The lab’s location in central US will also shorten the turn-around time for samples sent in from North America. Together with the company’s recent distribution agreement with health and wellness technology leader Stay Healthy, Inc. (“Stayhealthy”), geneType is poised for exponential growth across North America.

Stemming from its significant contributions to the Human Genome Project nearly 20 years ago, GTG pioneered and patented the burgeoning area of genetic testing known as polygenic risk score (PRS). By combining PRS with clinical risk models, the company has refined a suite of integrated genetic testing and assessment tools designed to assess an individual’s risk for serious disease and ultimately enable actionable recommendations to help mitigate that risk.

Since the first geneType assessment for breast cancer was developed, in 2022 after 20 years of research, the company has developed a Multi–Risk test which is a comprehensive suite of the most innovative tests for nine specific diseases (as one non-invasive cheek swab) evaluating risk for metabolic, cardiovascular, and oncological diseases, covering 70 percent of annual mortality and morbidities. Clinical-grade assessments for new cancers and chronic conditions are in development. GeneType’s non-invasive, saliva-based tests are clinically validated and regulatory approved.

“As personalized medicine and health-consciousness continue to trend upwards, we are confident that the uniquely integrated, highly accurate geneType test will continue to meet the rising demand for personalized, actionable health information,” said Simon Morriss, CEO of Genetic Technologies. “Our collaboration with Gene by Gene and Stayhealthy solidifies the infrastructure needed to deliver that information so that individuals and healthcare providers in North America can take control of their health.”

Stayhealthy’s partnership with geneType will bring geneType’s innovative suite of tests to a broader consumer base through employee health benefits and online pharmacy channels across the US and Canada. In 2023, Stayhealthy launched a Direct to Consumer (DTC) online discount pharmacy card and website with access of up to 1.5 million users and a Business to Business to Consumer (B2B2C) with Level 5 Section 125 (cafeteria) plan for employers and workers. With a database of over 200 million U.S. email addresses, Stayhealthy is well-positioned to promote geneType’s portfolio of personalized health risk assessments across North America.

John Collins, CEO of Stayhealthy, stated, “Our mission at Stayhealthy is to empower individuals to take control of their health. GeneType’s non-invasive, predictive genetic testing not only complements our mission; it also integrates perfectly with our technology.”

For more information, please visit GeneType.com, GenebyGene.com, and Stayhealthy.com.

For media inquiries, contact:
Mara Quigley
Steve Allen Media
E: mara@steveallenmedia.com
661.255.8283

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GTG offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products. For more information, please visit www.genetype.com

About Gene by Gene

Gene By Gene is a world leader in genetic testing services with over 20 years of experience. Our laboratory holds accreditation from multiple agencies, including CAP, CLIA, New York State Department of Health, California Department of Public Health, and AABB. With a cutting-edge laboratory and highly trained team of experts, we are committed to excellence in the field of genetic analysis. www.genebygene.com

About Stayhealthy

Founded in 1995, Stayhealthy Inc. is a healthcare technology company that has brought together the most advanced tools to measure, track and change millions of users' health and wellness status. With its diverse team of experts and creative minds from medicine, science, technology, media, advertising, and design, Stayhealthy has launched mobile platforms with a robust suite of personalized healthcare apps. These offerings are differentiated not only through their highly accurate, clinically valid screening tools but with their dynamic use of augmented reality images created using patented technology, as a way to add further emotional impact. www.stayhealthy.com

Forward Looking Statements

This announcement 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 U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of the Company's authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. As forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause the Company's actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause the Company's actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements as detailed in the Company's filings with the Securities and Exchange Commission and in its periodic filings with the ASX in Australia and the risks and risk factors included therein. In addition, the Company operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. The Company does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.


FAQ

What is the impact of Genetic Technologies launching geneType operations in the U.S.?

The launch increases operational capacity to 25,000 tests per month and reduces turnaround times for North American samples.

How does the partnership with Stayhealthy benefit Genetic Technologies?

Stayhealthy's channels provide geneType access to up to 1.5 million users and 200 million email addresses, broadening consumer reach.

What diseases does the geneType Multi-Risk test cover?

The geneType Multi-Risk test covers risks for nine diseases, including metabolic, cardiovascular, and oncological conditions.

What is the significance of Gene by Gene's central U.S. location?

Gene by Gene's location reduces turnaround times for samples sent from North America, improving efficiency.

Are geneType tests validated and approved?

Yes, geneType tests are clinically validated and regulatory approved.

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