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GTG Launches Revolutionary geneType Test covering 100% Risk of Breast and Ovarian Cancer

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Genetic Technologies (ASX: GTG; NASDAQ: GENE) unveiled its innovative geneType Comprehensive Risk Assessment test, targeting 100% of women at risk of breast and ovarian cancer. This test, launched at the 'Know Your Risk' event in California, evaluates both hereditary and sporadic cancer risks for women over 30. The event, co-hosted by Dr. Kristi Funk and Krystal Barter, emphasized genomics' role in women's health. The geneType test represents a significant advancement in preventative healthcare, covering 1 in 8 women in the US at risk for breast cancer (310,000 annual diagnoses) and 19,600 ovarian cancer cases yearly. GTG's new high-throughput automated lab in the US can handle up to 100,000 tests per month, anticipating high demand.

Positive
  • Launch of a groundbreaking test covering 100% of women at risk of breast and ovarian cancer.
  • The test assesses both hereditary and sporadic cancer risks, available for women over 30.
  • Significant market opportunity with 1 in 8 US women at risk of breast cancer, equating to 310,000 annual diagnoses.
  • Capability to handle up to 100,000 tests per month with the new high-throughput automated lab.
  • Strong endorsements from healthcare professionals and strategic partners.
Negative
  • High operational costs anticipated in scaling the automated lab for mass testing.
  • Competitive market potentially affecting the unique positioning of the geneType test.
  • Dependence on retrospective data, which may not fully predict future demand or success.
  • Potential logistical challenges in managing a vast volume of tests monthly.

Insights

The launch of GTG's new Comprehensive Risk Assessment test represents a significant milestone in genetic testing and preventative healthcare. Given that GTG operates in the genomics-based tests market, this new product expands their market reach considerably, especially in addressing both hereditary and sporadic cases of breast and ovarian cancer. From a financial perspective, the claim of covering 100% of women at risk could position GTG as a leader in this segment, potentially driving revenue growth through increased adoption of their testing services.

The company's preparation for high demand with a capacity to run 100,000 tests per month indicates a strong confidence in the market potential. Given the high incidence rates of these cancers, particularly breast cancer with about 310,000 diagnosed cases annually in the US, the addressable market is substantial. The ability to scale quickly is a positive indicator of GTG's operational readiness and potential to capture a larger market share.

However, investors should be cautious about the execution risks involved in expanding capacity and scaling operations. The company's financial health will also be important to monitor during this expansion phase.

The new geneType Comprehensive Risk Assessment test is a notable advance in preventative healthcare, especially due to its ability to cover both hereditary and sporadic cases of breast and ovarian cancer. Genomic testing has been a growing field, but the ability to screen 100% of women at risk and provide a personalized risk profile is truly innovative. This can significantly improve early diagnosis and intervention strategies, potentially reducing mortality rates associated with these cancers.

One point to consider is the clinical validation of the test. Investors should look for continued data supporting its efficacy and reliability. The retrospective data indicating that 5% to 10% of such cancers are due to gene mutations while the rest are sporadic underscores the importance of comprehensive testing.

In addition, the involvement of high-profile medical professionals and strategic partnerships with employer groups and clinics can enhance the credibility and adoption of the test. However, the success of this product will largely depend on its integration into clinical practice and insurance coverage.

GTG's launch event and the involvement of notable figures in the healthcare industry, such as Dr. Kristi Funk, underscore the market positioning and marketing strategy behind this new test. The emphasis on the Know Your Risk event highlights the company's effort to educate and attract potential users, which is key in gaining market acceptance.

The statistics provided—1 in 8 women in the US developing breast cancer and the deadly nature of ovarian cancer—highlight the market need for such comprehensive tests. By addressing both hereditary and sporadic cases, GTG is poised to cater to a wider audience, potentially leading to a high market penetration rate.

From a market perspective, the scalability of their automated laboratory in the US to handle up to 100,000 tests per month is a strategic move to meet anticipated demand. This reflects positively on their preparedness to capitalize on the market opportunity.

Nonetheless, market penetration will also depend on competitive dynamics, pricing strategy and the ability to demonstrate clear clinical benefits to both patients and healthcare providers.

MELBOURNE, Australia, May 29, 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,

is pleased to announce the Company has released its novel Comprehensive Risk Assessment test that covers 100% of women at risk of developing breast and ovarian cancer. The innovative test, available to all women above the age of 30, assesses a woman’s risk of cancer due to hereditary, including those with common gene mutations, and sporadic disease.

Launched at the inaugural “Know Your Risk” event in California, USA, the event provided invaluable insights of the role of genomics in women’s health. Co-hosted by Dr Kristi Funk, known for her surgical treatment of celebrity Angelina Jolie, alongside CEO & Founder of Humanise Health, Krystal Barter, the event also featured panellists such as US based OB-GYN Dr. Carolynn Young, Andrea Hans, Allyn Rose Oertel, and Matthew Zachary.

This new geneType Comprehensive Risk Assessment test represents a significant leap in preventative healthcare, whereby clinicians will have a complete understanding of their patient’s risk profile of developing one of the deadly cancers. The addition of the germline component to GTG’s platform provided the ability to screen 100% of women at risk. Retrospective data shows 5% to 10% of breast and ovarian cancers are caused by gene mutations and the remainder are due to sporadic condition.

This represents a massive market opportunity for geneType, with 1 in 8 chances of a woman in the US developing breast cancer equating to about 310,000 diagnosed cases annually. Although less prevalent, ovarian cancer accounts for 19,600 cases diagnosed yearly in the US and claims 12,700 deaths annually. Ovarian cancer is more deadly and is among the leading cause of cancer deaths in women¹. Dr Kirsti Funk noted that “Understanding your cancer risk based on critical diet and lifestyle and genetic factors allows me to create a more directed, effective risk-reducing strategy.²”

This advancement in personalised preventative healthcare, was welcomed by the company’s strategic partners in employer groups, functional medicine clinics and existing physician networks. The OB-GYNs are overwhelmingly excited about this launch and expressed their satisfactions on the abilities of our new comprehensive test for early diagnosis and ultimately saving lives.

GTG’s CEO, Simon Morriss, said “We are incredibly proud to have been part of this ‘Know Your Risk’ event which underscored the importance of genetic testing and risk assessment in transforming women’s health, inspiring attendees to advocate for their health and well-being proactively. We are also very fortunate and to have the opportunity to launch this unique risk assessment test in the presence of such a wonderful group of people”.

Peter Rubinstein, GTG’s Chairman commented, “We are also excited to announce that in preparation for significant demand for this revolutionary test we have fully onboarded a high throughput automated laboratory in the United States with capacity to scale up to run 100,000 tests per month should future demand require. Every woman deserves the right to know her risk”.

For more information, please visit www.genetype.com.

Authorised for release by the Board of Directors.

Enquiries
Simon Morriss
Chief Executive Officer
E: investors@genetype.com

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

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.

_____________________________
¹ https://www.cancer.org/cancer/types/ovarian-cancer/about/key-statistics.html
² https://www.instagram.com/p/C7XX-sKygdG/?utm_source=ig_web_copy_link


FAQ

What is Genetic Technologies 's new geneType test?

The geneType Comprehensive Risk Assessment test covers 100% of women at risk of breast and ovarian cancer, assessing both hereditary and sporadic risks.

When was the geneType Comprehensive Risk Assessment test launched?

The test was launched on May 29, 2024, at the inaugural 'Know Your Risk' event in California.

Who is the geneType test available to?

The test is available to all women above the age of 30.

What is the market opportunity for the geneType test?

The geneType test targets 1 in 8 women in the US at risk of breast cancer, equating to about 310,000 diagnoses annually, and 19,600 ovarian cancer cases yearly.

What is the throughput capacity of GTG's new lab?

GTG's new automated lab can handle up to 100,000 tests per month.

Genetic Technologies Ltd.

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