Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

FORM 6-K

U.S. SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE

SECURITIES EXCHANGE ACT OF 1934

dated September 11, 2023

Commission File Number 0-51504

GENETIC TECHNOLOGIES LIMITED

(Exact Name as Specified in its Charter)

N/A

(Translation of Registrant’s Name)

60-66 Hanover Street

Fitzroy

Victoria 3065 Australia

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒ Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes ☐ No ☒

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): Not applicable.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused the Report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: September 11, 2023

	GENETIC TECHNOLOGIES LIMITED

	By:	/s/ Tony Di Pietro
	Name:	Tony Di Pietro
	Title:	Company Secretary

EXHIBIT INDEX

Exhibit		Description of Exhibit

99.1		MRFF Grant names GTG as sole Industry Partner

Exhibit 99.1

MRFF Grant names GTG as sole Industry Partner

Trial to Assess Multi Cancer Genetic Risk Assessment in General Practice

Melbourne, Australia, 11 September 2023: 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 that a Medical Research Future Fund (MRFF) Genomics Health Futures Mission Grant has been awarded to a group of renowned national and international research and charity organisations. The grant will provide funding for the CASSOWARY Trial: a randomised controlled trial of the clinical utility and cost-effectiveness of a multi-cancer polygenic risk score in general practice. GTG is the National Research Partner for trial which is to be led by Professor Jon Emery.

Highlights:

	●	Results from the trial are expected to change the way risk is assessed and reshape the standard of care in general practice for serious disease.
	●	The trial results will inform future policy including the 5-year goal in the Australian Cancer Plan of using genomics for risk-stratified cancer screening.
	●	Results of this study could lead to a revision of national guidelines and improve risk stratification for four of the most common cancers in Australia; breast, colorectal, prostate, and melanoma.
	●	The study will recruit nearly 600 participants from eight general practices across Victoria.
	●	As the sole industry partner, GTG will receive funding to cover the supply of test kits and the analysis of the sample returned.

The project titled, “The CASSOWARY (CAncer genomic riSk ScOres in primARY Care) Trial: a randomised controlled trial of the clinical utility and cost-effectiveness of a multi-cancer polygenic risk score in general practice,”. This is a multi-institutional, multidisciplinary collaborative initiative with internationally recognised experts. Disciplines include academic, general practice and primary care trials, clinical genetics and genetic counselling, genetic/cancer epidemiology, health economics and modelling, biostatistics, implementation science, genomic test development and commercialisation, consumer investigators with lived experience of cancer and associate investigators with expertise in cancer policy with Cancer Australia. The Cassowary Trial is a collaboration between international investigators from GTG (Industry partner), University of Melbourne and Queen Mary University of London, The Royal Melbourne Hospital, Royal Marsden NHS Foundation Trust, and the Daffodil Centre.

The study will recruit a targeted cohort to create high quality evidence about the clinical utility and cost-effectiveness of using cancer polygenic risk scores, such as geneType multi-Test to tailor cancer screening and possible treatment in general practice.

Professor Jon Emery, the lead investigator of this study team, has an established history in genomics in Australian general practice and has been involved in national and international screening and cancer risk assessment guidelines. This funding is one of several trials that he leads, “We look forward to extending our work in the space of polygenic risk score implementation in general practice. Over the years, our team has created a framework for risk-assessment implementation in clinical practice, and with each subsequent study we are building our evidence to support a structured, real-world implementation strategy.”

Genetic Technologies Limited

www.genetype.com

info@gtglabs.com

ABN 17 009 212 328

60-66 Hanover Street

Fitzroy Victoria 3065

Australia

+61 3 8412 7000

This multi-year utility trial will focus on the implementation of four of geneType’s multi-Test integrated polygenic risk scores: breast, colorectal, prostate, and melanoma. The trial will assess patient and provider behaviour, and assess the economic impact of the resulting behaviour.

GTG’s Director of Scientific Affairs, Erika Spaeth, a co-investigator of the study said, “We are proud of our academic partnerships and honoured to be a part of the growing body of evidence showing the utility of polygenic risk in clinical care. We look forward to the implementation evidence outcomes that will result from this utility study.”

GTG has a strong history of research partnerships with academic institutions, including the University of Melbourne. The company is committed to its collaborative initiatives that support the evolution of predictive population healthcare. GTG’s CEO, Simon Morriss noted, “This is an important step forward for preventive precision medicine. The results from the Cassowary Trial have the ability to support the clinical utility of geneType multi-Test and even more importantly provide compelling evidence for its’ inclusion into National Guidelines and standard of care. The results from this study will be a major leap forward for geneType.”

-END-

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

Enquiries

Investor Relations

Adrian Mulcahy

Automic Markets

M: +61 438 630 411

E: 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 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.