Genetic Technologies Provides Update on COVID-19 Risk Test Launch
Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) announced progress on the US commercial availability of its COVID-19 Serious Disease Risk Test through Infinity BiologiX (IBX).
The validation and data analysis for the test have been completed, with IBX finalizing a technical interface for submission to the Centers for Medicare and Medicaid Services before commercial launch.
IBX, with three labs in New Jersey and Minnesota, is positioned to process over 100,000 tests daily, aiding in the risk assessment of serious COVID-19 cases using genetic and clinical data.
- Completion of validation and data analysis for COVID-19 Risk Test.
- Technical interface nearing completion for Medicare submission.
- IBX positioned to process over 100,000 tests daily.
- None.
MELBOURNE, Australia, April 09, 2021 (GLOBE NEWSWIRE) -- Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a diversified Genomics and AI driven preventative health business provides an update to the market on the progress of the US commercial availability of the Company’s COVID-19 Serious Disease Risk (“COVID-19 Risk Test”) via US Based Infinity BiologiX LLC (‘IBX’), (ref: ASX Announcement 3 March 2021).
Genetic Technologies advises that the Company has completed all validation and data-based analysis for the COVID-19 Risk Test. IBX, our US based distribution partner is currently completing the technical interface with their telehealth partner for the commercial availability of the COVID-19 Risk Test across the United States.
The technical interface is a requirement for the submission to Centres for Medicare and Medicaid Services (‘CMS’), with submission required prior to the commercial release of the COVID-19 Risk Test by IBX.
IBX has three well-established labs, with two in New Jersey and one in Minnesota and a network of COVID-19 testing partners, with access to testing sites across the country providing a clear pathway for the sale and distribution of GTG’s COVID-19 Risk Test.
GTG’s COVID-19 Risk Test may enable the risk assessment of an individual developing a serious disease should they contract the COVID-19 virus. The COVID-19 Risk Test is intended to predict ‘disease severity’ using a combination of genetic and clinical information.
“Our COVID-19 Risk Test is a crucial product that will provide individuals with the ability to understand their personal risk associated with contracting a serious case of this disease,” commented Simon Morriss, CEO of GTG. “Alongside existing treatment options and vaccines, we believe this test will enable more insightful decisions for states, workplaces and individuals on pathways forward in managing this pandemic.”
IBX is a market-disrupting central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas.
IBX launched its COVID-19 saliva-test in May 2020, after receiving FDA Emergency Use Authorization. It was the first test to utilize saliva as the primary biomaterial for SARS-CoV-2, and IBX subsequently became the first company to offer an at-home collection with this approach.
IBX currently has the capacity to process over 100,000 COVID-19 Risk Tests per day across its two major labs and is well-positioned with an existing network of SARS-CoV-2 testing partners and associated medical practitioners across the US to be able to use GTG's COVID-19 Risk Test in conjunction with these existing third-party SARS-CoV-2 Tests.
Further updates will be provided in due course.
Authorised by the Board of Genetic Technologies
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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.gtglabs.com
About Infinity BiologiX:
Infinity BiologiX (IBX) is a market-disrupting next-generation central laboratory supporting academia, government, and industry. IBX provides global sample collection, processing, storage, and analytical services integrated with scientific and technical support in both the research and clinical arenas. As a leader in biomaterials, IBX provides support to the development of diagnostics, therapeutics, and research in the genomics, precision, and regenerative medicine arenas. IBX previously operated as RUCDR Infinite Biologics before spinning off from Rutgers University-New Brunswick in August 2020.
For more information, visit www.ibx.bio
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