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Genetic Technologies Limited (GTG.AX)

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  • GlobeNewswire

    Genetic Technologies Provides Update on COVID-19 Disease Severity Test Development

    MELBOURNE, Australia, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Limited (ASX: GTG, NASDAQ:GENE) (“Genetic Technologies” or the "Company") is developing a Polygenic Risk Score (PRS) test for COVID-19 which may enable an assessment of risk of an individual developing a serious disease should they contract the virus. The test is intended to predict ‘disease severity’ using a combination of genetic and clinical information. The Company is pleased to provide the following update on the test development program: * Completed development of a prototype Polygenic Risk Score * Completed development of a clinical risk model * Completed evaluation of the combined (clinical + polygenic) comprehensive risk model * Sourced cross validation data (expected late September / early October) * Filed provisional patent * Identified potential partner for pilot scale implementation study and commenced discussions * Completed preliminary analysis of “Workforce Management by Polygenetic Testing” Genetic Technologies utilized existing relationships with international biobanks and health studies to secure the requisite patient data to develop its COVID-19 Disease Severity Risk Test. The Company is extremely pleased with the early performance characteristics of the prototype test.  Crucial to the completion of the test is a cross validation of the model in an independent dataset. Although the State of Victoria in Australia has experienced a significant second wave of COVID-19 cases, the requisite data is not available locally at this time. To complete the test development process, the Company has sourced additional data from Europe that is expected to be available in late September / early October.The Company expects to submit the test validation studies for publication in the mainstream medical literature and make the data publicly available at the same time.Genetic Technologies has designed and ordered its first SNP (Single Nucleotide Polymorphism) array panel from US-based Thermo Fisher Scientific Inc, a world leader in genetic testing and GTG manufacturing partner for GeneType products. The first batch of prototype arrays are expected to be delivered to the Company’s laboratory during the week of September 21, 2020 and will be used to validate and verify the laboratory process prior to submission of the test for regulatory approval.As reported in the Company’s Quarterly Activities Report on July 29, 2020, the Company has held discussions to confirm procedural information with the Centres for Medicare and Medicaid Services (CMS) and National Association of testing Authorities, Australia (“NATA”) for regulatory Approval for the COVID-19 Disease Severity Risk Test in the United States and Australia.The submission of the technical file (to include scientific literature, algorithm validation, lab wet-work validation and laboratory procedural documentation) will be made to both organisations. Genetic Technologies has filed a provisional patent application for its COVID-19 Disease Severity Risk Test with IP Australia (2020901739 – Methods of assessing risk developing a severe response to Coronavirus infection). The provisional patent covers the specific SNP algorithm designed by the Company to calculate a PRS and the testing model that combines PRS and the clinical risk factors that together constitute the COVID-19 Disease Severity Risk Test.The test is intended to provide risk stratification information which may help personal and population management in two ways: * Providing risk stratification to guide quarantine measures on a personal, local, and national scale; and * Providing risk stratification to prioritise vaccination if and when a vaccine becomes availableIn preparation for the requirement to demonstrate supporting clinical utility of our approach, the Company has commenced a collaborative study to model the impacts on workforce protection through the use of the COVID-19 severity risk test. Employers cannot afford to close every time infections arise without significant damage to their businesses. The current modelling studies are designed to provide tailored workforce policies based on individual employee risk profiles provided by Genetic Technologies’ COVID-19 Disease Severity Risk Test.Genetic Technologies prototype COVID-19 test combining demographic factors, health indicators and polygenetic characteristics is able to identify individuals most at risk of hospitalisation if they are infected with COVID-19. Based on the characteristics of the prototype test, individuals in the top decile of polygenetic scores are more than three times as likely to require hospitalisation as those with average polygenetic scores. More accurate identification of individuals at highest risk could enable employers to tailor return to work and work at home policies that provide most protection. Modelling work undertaken by Sam Lovick Consulting using results from the prototype shows that tailored work from home policies based on the test, when combined with precautions against infection for home-based workers, could reduce workforce hospitalisations by between 20% and 65% (depending upon the proportion of home-based workers and the extent of infection in the community); a company with 10,000 employees could potentially reduce hospitalisations by 290 resulting in 10 fewer deaths.Preliminary discussions have been held with potential collaborating organizations to test this approach within a real workplace and will be announced in due course.On 11 September 2020 GTG announced that initial sales of its GeneType for Breast Cancer Risk Assessment commenced in the United States via an online health platform, elicity by InTeleLabs, an independent telehealth and personalised medicine company.The Company will now expand this online sales capability by making the COVID-19 Disease Severity Risk Test available to US customers, targeted as a Q4 2020 release.Dr George Muchnicki Acting CEO and Justyn Stedwell Company Secretary On behalf of the Board of Directors Genetic Technologies Limited +61 3 8412 7000Investor Relations and Media (US)Dave Gentry, CEO RedChip Companies Office: 1 800 RED CHIP (733 2447) Cell: US 407 491 4498 dave@redchip.com Australia Trevor Chappell WE Communications Email: tchappell@we-worldwide.com T: +61 407 933 43About Genetic Technologies LimitedGenetic 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 has capacity for COVID-19 testing and is developing a pipeline of risk assessment products.For more information, please visit www.gtglabs.com.Forward-Looking StatementsThis 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.

  • GlobeNewswire

    Genetic Technologies Announces US Sales Have Commenced via Online Health Platform

    MELBOURNE, Australia, Sept. 11, 2020 (GLOBE NEWSWIRE) -- Molecular diagnostics company Genetic Technologies Ltd (ASX: GTG; NASDAQ: GENE, “Company”) is delighted to announce that initial sales of its GeneType for Breast Cancer Risk Assessment have now commenced in the United States via an online health platform, elicity by InTeleLabs, an independent telehealth and personalised medicine company. This portal is secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant.The secure, Health Insurance Portability and Accountability Act (HIPAA)-compliant health platform enables women meeting the required criteria in the United States to purchase the test and receive results via telehealth clinicians. Its national network of clinical oversight for lab testing has made this groundbreaking Breast Cancer Risk Assessment Test very accessible, with the data-driven results enabling more women to discuss personalised preventative healthcare protocols with their physicians.GeneType for Breast Cancer is a disease risk prediction test that provides results that inform individuals if they are at low-, average- or high-risk of developing breast cancer. The test uses a patented combination of clinical risk factors and Polygenic Risk Score (PRS) to provide an estimate of the five-year and remaining lifetime risk of developing breast cancer.The test will be available in every State throughout the US, as the Company has CLIA certification for the sale and processing for all its lab-derived tests. GeneType for Breast Cancer will sell for US$249 and include the telemedicine consultations through InTeleLabs.Most tests currently available on the market are for women who have a family history of breast cancer, however 85 per cent of women have no family history of breast cancer, according to the American Society of Clinical Oncology. Further to this, 10 per cent have a family history but no pathogenic variants, such as BRCA [Cancer.Net, July 2020].“The Company’s GeneType for Breast Cancer is uniquely positioned to provide risk assessment to the general population—not just for women at hereditary risk. Our goal was always to give individuals unprecedented access to their own genetic data to understand their health risks and take a more proactive approach to prevention,” said Genetic Technologies CEO Dr George Muchnicki. “GeneType for Breast Cancer outperforms current standard risk assessment tools, giving clinicians and patients a better way to identify at-risk women for additional breast cancer screening and prevention options. Making this test available via telehealth clinicians gives individuals interested in risk assessment another avenue for access.”Once a woman is qualified by an independent telehealth clinician, a buccal swab kit (cheek swab) is sent directly to her home. After her results are in, telehealth clinicians provide post-test consultations to deliver the breast cancer risk assessment results and provide additional support for those who require referrals for appropriate downstream care. Women interested in purchasing GeneType for Breast Cancer may do so through gtglabs.com/breast-cancer or elicity.health/our-tests/details/breast-cancer-risk.“COVID-19 has deterred many women from seeking out standard check-ups, with mammography screening down since March,” said Dr Muchnicki. “While we suggest all women maintain their routine mammogram appointments, women who are still not comfortable scheduling their appointment, or clinics with an extremely long waitlist as they ramp back up, risk assessment can be a valuable tool to identify women who are at increased risk of breast cancer. GeneType for Breast Cancer should never be used as a mammogram-replacement, only as an additional tool to help individuals build a more comprehensive understanding of their own risk of developing the disease.”In addition to GeneType for Breast Cancer, GeneType for Colorectal Cancer will also be available through the third-party online platform as well as a pipeline of tests to follow.Genetic Technologies plans on launching its own online, telehealth-supported system to deliver its GeneType products to Australians.The Company intends to make its COVID-19 Severity Risk Test available through both online platforms, once complete.For further information, please visit: https://genetype.com/for-patients/breast-cancer-questionnaire/.Dr George Muchnicki Acting CEO and Justyn Stedwell Company Secretary On behalf of the Board of Directors Genetic Technologies Limited +61 3 9412 7000About Genetic Technologies LimitedGenetic 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 has capacity for Covid-19 testing and is developing a pipeline of risk assessment products.For more information, please visit www.gtglabs.com.Forward-Looking StatementsThis 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.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

  • GlobeNewswire

    Genetic Technologies Regains Compliance with Nasdaq Stockholders Equity Requirement

    MELBOURNE, Australia, Sept. 01, 2020 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) (the “Company”), a leader in the development of genetic risk assessment tests, is pleased to announce that it received notification from the Listing Qualifications Department of the Nasdaq Stock Market indicating that the Company has met the minimum stockholders equity requirement set forth in Listing Rule 5550(b)(1). Nasdaq has determined that the Company complies with Listing Rule 5550(b)(1), which requires a stockholders’ equity of $2.5 million. Since April 2020, Genetic Technologies has raised an aggregate of $16.37 million through offerings of its American Depositary Shares, and as a result, as of August 28, 2020, it has US GAAP stockholders’ equity in excess of $2.5 million.Accordingly, the Company's American Depositary Shares will continue to be listed on The Nasdaq Capital Market and Nasdaq considers the matter closed.About Genetic Technologies LimitedGenetic 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 has capacity for Covid-19 testing and is developing a pipeline of risk assessment products.For more information, please visit www.gtglabs.com.Forward-Looking StatementsThis press release may contain forward-looking statements about the Company’s expectations, beliefs or intentions regarding, among other things, statements regarding the offering, the expected gross proceeds and the expected closing of the offering. 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.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