Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, ‘Company’, ‘GENE’, ‘geneType’), a global leader in genomics-based tests in health, wellness and serious disease provides the following business update:

Rhea-AI Summary

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) reported a 112% increase in projected cash receipts to A$1.8 million in 2QFY22, driven by the successful integration of EasyDNA. The company completed submissions for its Multi-Test product to NATA and CMS, expecting regulatory approval soon. As part of its growth strategy, the US patent application for the geneType COVID-19 Risk Test has been accepted, and a cross-validation study confirmed its effectiveness. Strategic partnerships with 1Health and IBX enhance patient distribution networks.

Positive

• Projected cash receipts of A$1.8 million for 2QFY22, a 112% increase from prior quarter.
• Successful integration of EasyDNA aligning with acquisition expectations.
• Completion of technical validation for Multi-Test, awaiting regulatory approval.
• Acceptance of US patent application for geneType COVID-19 Risk Test.
• Cross-validation study confirms performance of geneType COVID-19 Risk Test.
• New partnerships with 1Health and IBX to expand patient distribution network.

Negative

• None.

• Forecast 2QFY22¹ cash receipts +112% versus the prior quarter (1QFY22) to A$1.8 million following the completed integration of EasyDNA in the quarter
  
• Multi-Test technical validation complete and submitted to NATA² and CMS³ for final regulatory approval ahead of the commercial release
• US patent application for novel geneType COVID-19 Risk Test has been accepted and cross validation study completed in independent cohort confirming test performance and utility
• Enhanced patient distribution network with new partnership agreement with 1Health and IBX
• Study Involving 200,000 participants presented at 2021 San Antonio Breast Cancer Symposium validating the risk model with an expanded panel of 313 Single Nucleotide Polymorphisms (SNPs)
  

MELBOURNE, Australia., Dec. 21, 2021 (GLOBE NEWSWIRE) -- The Company confirms the completion of the integration of EasyDNA and expects to deliver customer receipts for the quarter of A$1.8 million, a 112% increase on the prior quarter and in line with acquisition expectations. In the coming quarters, the focus will be on further leveraging the acquisition by including the Multi-Test product, where we expect to see solid growth in revenue across all brands and products as these initiatives are rolled out.

The Company is set to release phase one of the Multi-Test subject to final regulatory approval and confirms that all regulatory submissions to NATA and CMS have been completed. NATA completed their onsite audit of GENE’s Melbourne laboratory on December 15, 2021. The certifying body is preparing their final documentation on the audit in the coming weeks. This phase one launch is the culmination of 10+ years of research and development and includes Breast Cancer, Colorectal Cancer, Ovarian Cancer, Prostate Cancer, Coronary Artery Disease and Type 2 diabetes. The Company is now focused on finalizing commercial distribution opportunities via our EasyDNA brand and through our existing partner network with IBX, 1 Health and Vitagene.

GENE’s CEO, Simon Morriss, noted, “We have delivered solid growth with strong advancement against our strategic objectives and continue to build on our history of genetics-based research. We confirmed that our geneType COVID-19 Risk Test is now available through our US partners, IBX and 1Health, and customers should consider this as an optional ‘add on’ request for a COVID-19 polymerase chain reaction (PCR) test. We also completed our submissions to NATA and CMS in October and November respectively for our Multi-Test and are working closely with the regulators ahead of approval. These building blocks alongside further studies and industry engagement are enhancing the profile of GENE through our two brands, EasyDNA and geneType. We are pleased with the progress over the year and will continue the momentum achieved over the last few quarters as we launch into the new year.”

The Company announced in December 2021 a new partnership to expand access to the COVID-19 Risk Test in the US through its agreement with IBX and 1health on their ‘Vitagene’ platform directly from https://genetype.com/for-individuals/COVID-19. 1health is a leading US-based cloud platform service provider for diagnostic test management. 1health has built infrastructure that helps laboratories, such as IBX and their customers, connect patients to testing and care. 1health’s services will be managed in partnership with IBX under our exclusive license agreement.

GENE has continued to expand and develop the geneType COVID-19 Risk Test, having recently completed a cross-validation study on a European data set confirming the test performance metrics. A paper describing the study has now been submitted to a peer-reviewed journal and will be released upon publication. The emergence of the Omicron variant underscores the importance of identifying patients who are at greatest risk of developing severe disease.

In December 2021, GENE’s Director of Clinical Affairs, Dr Erika Spaeth presented a poster at the San Antonio Breast Cancer Symposium. In her presentation Dr Spaeth released new data that demonstrated an improved version of the Company’s geneType Breast Cancer Test with an expanded panel of 313 SNPs showed improved discrimination and calibration over traditional clinical models. The study included over 200,000 women and highlighted GTG’s commitment to the ongoing development of geneType Breast Cancer Risk Test.

“On behalf of the board and management we would like to thank you for your continued support, and we are looking forward to a very prosperous 2022,” added Morriss. 

Investor Relations (AUS)	Investor Relations and Media (US)
Stephanie Ottens	Dave Gentry
Market Eye	1 800 RED CHIP (733 2447)
M: +61 434 405 400	Cell: 407 491 4498
E: stephanie.ottens@marketeye.com.au	E: dave@redchip.com

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.genetype.com

Forward-Looking Statements

This 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.

^{____________________________}

¹ Projected customer receipts
² National Association of Testing Authorities, Australia
³ Centers for Medicare & Medicaid Services

A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/31457c36-bbad-45fd-aca7-6c0189ca2829

FAQ

What were the cash receipts for GENE in 2QFY22?

The projected cash receipts for Genetic Technologies Limited (GENE) in 2QFY22 were A$1.8 million, representing a 112% increase from the prior quarter.

What is the status of the Multi-Test product for GENE?

The Multi-Test product has completed technical validation and submissions to NATA and CMS, awaiting final regulatory approval.

What recent partnerships has GENE established?

Genetic Technologies Limited has formed new partnerships with 1Health and IBX to enhance its patient distribution network.

What is the significance of the geneType COVID-19 Risk Test for GENE?

The geneType COVID-19 Risk Test has had its US patent application accepted and has completed a cross-validation study confirming its performance, contributing to GENE's growth.

How many participants were involved in the breast cancer study presented by GENE?

The study presented by GENE involved over 200,000 participants and validated an improved version of the geneType Breast Cancer Test.