# EDGAR Filing Document

**Accession Number:** 0001166272
**File Stem:** 0001493152-23-003463
**Filing Date:** 2023-2
**Character Count:** 11437
**Document Hash:** 95595425d669008d6fa6edd70185a5ee
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-003463.hdr.sgml**: 20230203

**ACCESSION NUMBER**: 0001493152-23-003463

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 3

**CONFORMED PERIOD OF REPORT**: 20230203

**FILED AS OF DATE**: 20230203

**DATE AS OF CHANGE**: 20230203

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** GENETIC TECHNOLOGIES LTD
- **CENTRAL INDEX KEY:** 0001166272
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **IRS NUMBER:** 000000000

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 000-51504
- **FILM NUMBER:** 23583661

**BUSINESS ADDRESS:**
- **STREET 1:** 60-66 HANOVER STREET
- **CITY:** FITZROY, VICTORIA
- **STATE:** C3
- **ZIP:** 3065
- **BUSINESS PHONE:** 011613-9415-1135

**MAIL ADDRESS:**
- **STREET 1:** 60-66 HANOVER STREET
- **CITY:** FITZROY, VICTORIA
- **STATE:** C3
- **ZIP:** 3065

**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 February 3, 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: February 3, 2023

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| | |
|:---|:---|
| GENETIC TECHNOLOGIES LIMITED | GENETIC TECHNOLOGIES LIMITED |
| By: | */s/ Tony Di Pietro* |
| Name: | Tony Di Pietro |
| Title: | Company Secretary |

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EXHIBIT INDEX

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| | |
|:---|:---|
| **Exhibit** | **Description of Exhibit** |
| 99.62 | [20230203 – GTG to Launch World's First Comprehensive Risk Test for Breast & Ovarian Cancer FINAL](ex99-62.htm) |

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## Exhibit 99.62

**Exhibit 99.62**

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| | |
|:---|:---|
| **ASX Market Announcement** | ![](ex99-62_001.jpg) |

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**GTG to Launch World's First Comprehensive Risk Test for Breast & Ovarian Cancer**

**Melbourne, Australia, 3 February 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 the Company will launch a 'World First' Comprehensive Risk Assessment Test which evaluates a women's risk of developing Breast and/or Ovarian Cancer either from a hereditary genetic mutation or from the far more common familial or sporadic cancer. Combined with other clinical risk factors the test provides a comprehensive risk assessment in a simple saliva test.

**Highlights:**

● New
 test integrates the patented and proprietary GeneType platform for both Breast and Ovarian Cancer.

● GTG's
 unique approach "appends" the detection of the 13 major "actionable" breast and ovarian cancer susceptibility
 genes to the GeneType test platform.

● Results
 in a higher classification rate of women at elevated risk of breast and ovarian cancer than traditional clinical tools by assessing
 breast and ovarian cancer susceptibility from both rare and common genetic variants in addition to other known clinical risk factors
 associated with the development of both diseases.

● Advances
 the goal of providing population-based genetic screening for Breast and Ovarian cancer where up to 85% of cancers diagnosed do not
 have hereditary or family history<sup>1</sup>.

● The
 new test platform addresses those women over 30 years of age in the general population that are at higher risk of developing breast
 and/or ovarian cancer, not just from rare genetic mutations.

● The
 comprehensive risk assessment test will be clinically validated and have appropriate regulatory approval.

● This
 test will be launched via our Business to Business ('B2B') and Consumer Initiated Testing ('CIT') channels
 in the United States.

● The
 Comprehensive Risk Test will be showcased at the BRCA 2023 Symposium in Montreal in early May.

Globally, there are more than 2.26 million cases of Breast Cancer<sup>2</sup> and 313,000 cases of Ovarian Cancer<sup>3</sup> diagnosed annually. In the USA there are 297,790 new cases of invasive breast cancer that are diagnosed annually<sup>4</sup> and 19,880 women diagnosed with ovarian cancer<sup>5</sup>

Currently women are under screened and underdiagnosed for risk of hereditary breast and ovarian cancer syndrome (HBOC) based on their clinical criteria. There is considerable evidence that these criteria do not capture all women who are HBOC carriers. One recent general population screen among more than 6,000 women found that of 38 HBOC carriers identified nearly half would not have qualified for HBOC testing based on clinical criteria and their elevated risk of cancer would not have been identified.

<sup>1</sup> https://www.breastcancer.org/facts-statistics

<sup>2</sup> https://www.wcrf.org/cancer-trends/breast-cancer-statistics/

<sup>3</sup> https://www.wcrf.org/cancer-trends/ovarian-cancer-statistics/

<sup>4</sup> https://www.cancer.org/cancer/breast-cancer/about/how-common-is-breast-cancer.html

<sup>5</sup> https://www.cancer.net/cancer-types/ovarian-fallopian-tube-and-peritoneal-cancer/statistics

---

| | |
|:---|:---|
| Genetic Technologies Limited | 60-66 Hanover Street<br>|
| <u>www.genetype.com</u> | Fitzroy Victoria 3065<br>|
| <u>info@gtglabs.com</u><br>| Australia<br>|
| ABN 17 009 212 328 | +61 3 8412 7000<br>|

---

![](ex99-62_001.jpg)

GTG's comprehensive risk assessment for both cancers inform women of their risk profile and as a result, the opportunity to take proactive actions to increase screening and lessen their risk of developing these diseases. The risk assessment is performed from a single saliva sample and a brief questionnaire.

Implementation of the test as a population-based genetic screening for Breast and Ovarian is supported by GTG's independently developed Budget Impact Model ('BIM') providing a strong health and economic case for payers and insurers in the U.S. Supplemental screening in a subpopulation of women identified as at-risk by geneType can lead to an increase in early-stage, screen-detected cancers, which in turn is associated with high 5-year survival rates 99%<sup>6</sup> and 93%<sup>7</sup> for breast and ovarian, respectively.

GTG's CEO, Simon Morriss, commented "GTG believes this Comprehensive Risk Test for Breast and Ovarian Cancer is one of our most important and significant contributions to the advancement of population-based genetic testing. We are moving beyond rare cancer-susceptibility genetics. We can look for the needle in the haystack, but we are also able to look at the haystack itself. Our non-invasive risk assessment test will address cancer risk at a population health level."

-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: <u>adrian.mulcahy@automicgroup.com.au</u>

**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 <u>www.genetype.com</u>

**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.

<sup>6</sup> https://www.cancer.org/cancer/breast-cancer/understanding-a-breast-cancer-diagnosis/breast-cancer-survival-rates.html

<sup>7</sup> https://www.cancer.net/cancer-types/ovarian-fallopian-tube-and-peritoneal-cancer/statistics

---

| | |
|:---|:---|
| Genetic Technologies Limited | 60-66 Hanover Street<br>|
| <u>www.genetype.com</u> | Fitzroy Victoria 3065<br>|
| <u>info@gtglabs.com</u><br>| Australia<br>|
| ABN 17 009 212 328 | +61 3 8412 7000<br>|

---