GENE Genetic Technologies Ltd

Genetic Technologies Limited (ASX:GTG; NASDAQ:GENE,”Company”, “GTG”), a global leader in guideline-driven genomics-based tests in health, wellness and serious diseases, is pleased to provide the following business update for the first half of the 2023 financial year.

Operating in the multibillion dollar predictive and consumer genomics markets, GTG has achieved five consecutive quarters of growth. Our portfolio features the most comprehensive genetic solutions for the modern medical challenges. Our presence is building, now operating in more than 40 countries with more than 50 tests on offer via our global network of partner laboratories.

Our priorities focus on the following core areas to secure further commercial growth and revenue:

1. Business to Business (B2B) commercialisation of our geneType suite of tests
2. Demonstrating clinical validity and utility of our priopritary geneType platform
3. Driving revenue growth for EasyDNA and Affinity DNA with the introduction of new tests, distribution channels and markets.

1. Business to Business commercialisation of the geneType suite of testsThe Company’s geneType tests are underpinned by 27 patents, 18 of which are granted patents, protecting geneType sales in key markets.

Highlighting the Budget Impact Model (BIM) to US Payers is the cornerstone initiative that underpins GTG’s B2B strategy and therefore gaining coverage for geneType in the U.S.

Gaining coverage/reimbursement from payers in the U.S. is a key driver of step-change growth in revenues for geneType. For the geneType Breast Cancer Risk Assessment Test, multiple discussions highlighting the significant health and economic benefits of implementing the GeneType test (BIM) were held with U.S. employer groups, unions and health systems. This has led to positive engagement with Insurers and Payors. The BIM is is scalable for all payer systems and proven to deliver near tem ROI.

Currently we are engaged in more than ten active conversations with U.S. payer groups which combined have an aggregated covered lives total an estimated 42million people.

GTG are also targeting smaller niche payers such as employer groups. Commercial pilot studies highlighting the benefits of adopting the GeneType test with one or more payers are expected to commence during the coming months. Completion of these pilot studies are an important inflection point for the Company.

At the clinical practice level, GTG now has a number of independent clinics regularly referring patients for geneType tests, with new clinics being added weekly.

GTG has also engaged with a number of KOL’s in the U.S. who are actively supporting the implementation of the geneType risk assessment tests - these KOL’s including geneType:

• Dr Joel Evans
• Dr William Stanford
• Dr Lisa Larkin

In Australia, through the sales efforts of our Virtual Sales Representative (VSR) and face to face engagements using MedLab Medical Science Liaison personnel, over 90 medical practices are currently evaluating the geneType platform with their patients. A number of these have begun referring patients on a commercial basis.

GTG is continuing to build partnerships with key users in Australia including:

• Associate Professor Charles Siles who provides immediate access to more than 1,000 referring primary care physicians and 15,000 patients annually in Australia;
• Director and founder and Breast Speacialist, Dr Nicole Yap, at The Australian Breast Care Centre; and
• Professor Bruce Mann at Royal Women’s Hospital, Melbourne, where the breast cancer risk screening test was launched.

A number recent of media events are building the brand awareness of geneType. These included a segment on channel 7 News http://youtu.be/21SoDP8PTxg, a Webinar in which GTG’s Director of Medical Affairs, Dr Erika Spaeth, interviewed Associate Professor Charles Siles on the utility of geneType Breast Cancer Risk Assessment Test https://www.youtube.com/watch?v=Xmwn-WYFIeE, and an interview with GTG’s CEO, Simon Morriss, that aired on Bloomberg US https://youtu.be/YPBOPf8tPDE.

2. Demonstrate clinical validity and clinical utility of geneType platformIn recent weeks, GTG has announced the publication of three separate peer-reviewed papers in scientific journals which validate the benefits of the geneType test. These papers assess geneType as a predictor of breast cancer, ovarian cancer, cardiovascular disease (CVD) and type 2 diabetes. They each provide growing evidence of the clinical utility of geneType providing increased awareness amongst physicians which will assist in escalating the adoption of the geneType platform.

The publications are:

• “Polygenic risk scores for cardiovascular diseases and type 2 diabetes” published in PLOS ONE1;
• “A combined clinical and genetic model for predicting risk of ovarian cancer” published in the European Journal of Cancer Prevention2; and
• “Integrating Personalized Medicine into Preventative Care through Risk Stratification” published in the Journal of Precision Medicine3.

GTG will continue the strong commitment to scientific and clinical validity with our publication strategy in peer reviewed journals with innovation for geneType focussed on ethnicity diversity for a global healthcare system.

3. EasyDNA and Affinity DNA Revenue Growth: Tests, Channels & Markets

The Company’s revenue base continues to grow through the EasyDNA and Affinity brands.

Commercial achievements made during the half-year include:

• Launching a carrier test and Non-Invasive Prenatal Tests (NIPT) into Europe;
• Partnering in India with stud farms extending our paternity infrastructure into the equine industry;
• Launching a DNA storage solution within our Australian based NATA approved facility;
• Creating a NEW EasyDNA Website and eCommerce Platform, which is expected to launch in the coming weeks

Our growth strategy for EasyDNA focuses on expanding Direct-to-Consumer channels and our U.S. presence.

Authorised for release by the board of directors of Genetic Technologies Limited.

Enquiries

Investor RelationsAdrian MulcahyAutomic MarketsM: +61 438 630 411E: adrian.mulcahy@automicgroup.com.au

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 StatementsThis 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 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. Because 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 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.

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1 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.02787642 https://journals.lww.com/eurjcancerprev/Fulltext/9900/A_combined_clinical_and_genetic_model_for.27.aspx3 https://www.thejournalofprecisionmedicine.com/wp-content/uploads/integrating-personalized-medicine-preventive-care.pdf