Genetic Technologies Provides Update on its COVID-19 Disease Severity Risk Test and Expansion into Germline Testing

MELBOURNE, Australia, Jan. 21, 2021 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”), provides the following update to the market on further development on the COVID-19 serious disease risk Polygenic Risk Score Test (COVID-19 PRS Test) and expansion of the Company’s offering to include Germline Testing division.

Key Highlights

• Total COVID-19 positive patient data analyzed exceeds 5,500 following inclusion of further 4,000 patients’ data
  
    º  Predictive capabilities improved 100% over age and sex alone¹
  
    º  Analysis confirms that the test is well calibrated²
  
    º  Further datasets will continue to enhance the accuracy and consistency of the algorithm
• Anticipate submission for regulatory clearance via Centers for Medicare and Medicaid Services/Clinical Laboratory Improvement Amendments (CMS/CLIA) by the end of Q1 CY21 following final validation process of expanded dataset
• In active conversations on commercialization opportunities in conjunction with CLIA regulatory submission and clearance
• Additionally, as previously announced, the Company has commenced with equipment calibration along with specialized inhouse training of the scientific team to establish the Germline Testing division for hereditary cancer risk with initial focus on:
  
    º  BRCA testing to be offered in conjunction with GeneType for Breast Cancer, and
  
    º  Lynch Syndrome testing to be offered in conjunction with GeneType for Colorectal Cancer 

COVID-19 PRS Test

Product Advancements

Leveraging Genetic Technologies’ core expertise in predictive risk modelling, the Company utilized the initial dataset of 1,500 patients known to have a positive COVID-19 diagnosis from the UK biobank to develop a comprehensive predictive model to identify those patients most likely to require hospitalization should they become infected with the COVID-19 virus.

The UK biobank released a further dataset on COVID-19 positive patients consisting of ~4,000 confirmed COVID-19 infected patients in November 2020. Following further assessment the Company utilized this data to further update and validate the COVID-19 PRS Test. This has resulted in enhanced validation of the predictive capabilities of over 100%³ than disease risk severity based on age and gender alone and the test has been confirmed to be well calibrated⁴.

Further datasets are expected to be made available over the coming months and will be included in the platform to continue to enhance the predictive capabilities of the algorithm but will not impact on the current regulatory submission to CMS/CLIA by the end of Q1 CY21. These datasets will also enable further cross-validation and scientific publications based on the increased data and anticipated expansion of age assessment capabilities.

Laboratory Implementation

Laboratory reagents for performing the test commercially have been designed and are currently being validated in preparation for regulatory submission to CMS/CLIA with a view to targeting sales in the USA initially. The test is being validated as a multi-platform test, including as a Next Generation Sequencing Test, Mass array test with further platforms in development, to mitigate supply chain risk associated with the required reagents allowing for a de-risked commercialization pathway. This is also expected to provide greater flexibility for potential distribution partners. The laboratory reagents are being independently cross validated at the Australian Genome Research facility (AGRF).

Planned Commercialization

First-stage commercial distribution is intended to focus on engagement with key distributors in the US. The COVID-19 test was originally conceived as a personal and population-based risk management tool. Additional applications, now evident, may enable the ability to provide a test to assist in the prioritization of who will receive the vaccine first given the supply constraints and time for widespread access and a risk assessment tool for individuals given the rapid introduction of vaccines. The Company also anticipates that the knowledge gained may provide valuable insight for the development of a broadly applicable infectious-disease susceptibility model in the future.

Germline Testing Division

Expanding the scope of the GeneType Tests

As previously outlined, Genetic Technologies established the Germline Testing division following the strategic decision to offer hereditary testing for inherited cancer. The initial product focus for the division will be on BRCA testing to align with the Company’s GeneType for Breast Cancer product and Lynch Syndrome testing to align with the Company’s GeneType for Colorectal Cancer. This approach provides several strategic benefits, being the ability to identify cancer risk across the whole spectrum of cancer causation, from hereditary cancers caused by monogenic mutations to sporadic cancers with a polygenic, multifactorial cause.

Further announcements regarding the progression within the hereditary cancer testing will be provided as the Company progresses with the development and validation process.

Genetic Technologies Limited aims to provide a comprehensive risk assessment service across the full spectrum from sporadic to inherited disease.

Quarterly Results Release Date and Webinar

Genetic Technologies Ltd plans to release its quarterly results and activities report for the period ending December 31, 2020, on Thursday, January 28, 2021.

The Company will provide an update on further advancements to its diagnostic tests and hold an investor webinar to discuss the quarterly update, on Thursday, January 28, 2021 at 11:30 AEDT.

To participate on the quarterly investor webinar, please register at: 

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

Cautionary Note Regarding Forward-Looking Statements

Certain statements in this press release constitute "forward-looking statements," within the meaning of federal securities laws, including statements related to the Company's anticipated use of proceeds and plans and prospects and other statements containing the words "anticipate," "intend," "may," "plan," "predict," "will," "would," "could," "should," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The Company's actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the known risks, uncertainties and other factors described in the Company's prior filings and from time to time in the Company's subsequent filings with the Securities and Exchange Commission. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. All information in this press release is as of the date of the release and the Company does not undertake any duty to update this information, including any forward-looking statements, unless required by law.

SOURCE: Genetic Technologies Limited

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1</sup> Predictive accuracy of the test as assessed by analysis of the Area Under the Receiver Operating Characteristic Curve

² Calibration assessed using Pearson-Windmeijer goodness-of-fit test

³ Predictive accuracy of the test as assessed by analysis of the Area Under the Receiver Operating Characteristic Curve

⁴ Calibration assessed using Pearson-Windmeijer goodness-of-fit test