GENE Genetic Technologies Ltd

Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”), provides the following update to the market.

• Breast Cancer and Colorectal Cancer tests commissioned, and sales commenced First Quarter 2020 with over 100 test kits distributed.
• Early data generated from tests identified a number of high-risk individuals leading to personalised care plans designed for early detection
• Consumer Initiated Testing (CIT) via online and telemedicine to achieve mass market penetration and conserve scarce practitioner resources and implements social distancing

Colorectal test sales commence

As announced to the market on 31 January 2020, the Company has fully commissioned its Australian Laboratory for the provisioning of its generation 3 breast cancer test (GeneType for Breast Cancer), with sales having commenced during the quarter. We are pleased to report that this is now accompanied by the first-to-market GeneType for Colorectal Cancer test with sales also having now commenced.

Medical practitioner support

Both tests have been well received by medical practitioners, with over 15 clinics in Australia having agreed to offer the GeneType portfolio of tests. Overall, in excess of 100 test kits having been requested and approximately half of those samples have been received into the Melbourne laboratory during the first 4 weeks on market. 

High risk breast cancer patients detected

An interim analysis of those patients who received the GeneType for Breast Cancer test in Australia has revealed that 4 patients have already been identified as potentially being at high risk of developing breast cancer. It is highly significant that these patients were not eligible for hereditary mutation testing and would not have been identified as high risk during routine health checks.

Clinical utility and reimbursement initiatives Genetic Technologies continues to progress its in-house R&D program in support of the tests. Data derived from large scale cohort studies, have confirmed that both the discrimination and calibration of both GeneType tests are excellent and set the stage for progressing our plans to develop clinical utility evidence in support of our reimbursement strategy.

Clinical utility studies have been designed to support both the breast and colorectal cancer tests and the Company is currently engaging with potential clinical collaborators to complete these studies at the earliest opportunity. As alluded to above, the evidence is building that the GeneType tests have the potential to personalize individual screening recommendations.

Tele-health and Consumer Initiated testing to relieve practitioner stress and opens access to Mass consumer markets

Notwithstanding the above, the Company is taking an aggressive and pro-active response to the current COVID-19 pandemic. In light of world-wide recommendations on social distancing, which is impacting on our ability to fully engage with physicians, we have brought forward our plans to introduce a Consumer Initiated Testing (CIT) Platform. The Company is in the final stages of choosing an independent provider network who will oversee patient ordering of the consumer-initiated testing (CIT) pipeline. This sales pipeline deviates from a traditional sales approach that targets clinicians and instead allows patients to request a test directly, with clinician oversight of the testing process through an independent provider network and telemedicine. When a consumer is interested in purchasing a GeneType product, a clinician from this independent network will review the patient health history before confirming whether or not the patient may proceed with testing. The independent clinician will then order the test for the patient and will also review the final test results prior to delivering them back to the patient

In an age where primary care clinicians are overburdened by large patient volume and thus restricted to short clinical visits, certain disease risk assessments are often overlooked, particularly if the patient is asymptomatic, or visually “healthy”. 

The current push to adopt telemedicine as recently announced by Australia’s minister for Health Minister Greg Hunt is exactly on point with GTG’s CIT platform strategy and has been in development by GTG over the past 3 months.

Personalized proactive approach to health

Understanding a patient’s risk of developing disease can lead to earlier screening, more frequent and alternative surveillance methods, options for risk-reducing medications, and at the very least, some suggested lifestyle changes. However, in order to be proactive about screening and prevention measures, patients and physicians alike, must understand the patient’s risk of developing disease. By allowing our GeneType risk assessment product lines to be requested via CIT, we are enabling a patient to take a proactive approach to his/her healthcare.

Dr George Muchnicki Acting CEO and Justyn Stedwell Company Secretary On behalf of the Board of Directors Genetic Technologies Limited +61 3 9412 7000

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer for non-hereditary breast cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class.

Genetic Technologies is developing a pipeline of risk assessment products.

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

Investor Relations and Media (US) Dave Gentry, CEO RedChip Companies Office: 1 800 RED CHIP (733 2447) Cell: US 407 491 4498 dave@redchip.com 

Caution Regarding Forward-Looking Statements

This press release contains “forward-looking statements” Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, often signify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information that the Company has when those statements are made or management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.