Genetic Technologies’ COVID-19 Risk Test Approved for Commercial Release
April 26 2021 - 8:00AM
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 Test (‘COVID-19 Risk Test’) via US Based Infinity BiologiX LLC
(‘IBX’), (ref: Genetic Technologies press release on March 4,
2021).
The Company confirms the submission of the COVID-19 Risk Test
regulatory pack to the regulators1. In conjunction with prior
correspondence with the regulators this submission enables the
commercial release within the United States Final steps in the
technical interface are being built with additional capabilities
for the telehealth platform to enable sales of GTG’s COVID-19 Risk
Test and further products2 within markets outside of the United
States. The Company will provide further updates on regional
releases as and when they are confirmed.
The commercial release is expected to occur no later than the
end of May once the technical interface for the United States
telehealth platform is completed by IBXs telehealth partners.
Simon Morriss stated: “We are excited to be at the precipice of
the commercial release of our COVID-19 Risk Test. With IBXs testing
capacity of ~100,000 SARS CoV-2 Tests undertaken per day we look
forward to seeing this rolled out and informing individuals of
their risk of developing a serious case of COVID-19. Additionally,
broadening the opportunity set by building a platform that can
enable sales beyond the United States will be critical in
streamlining market expansions and future product launches.”
The Company will provide further details on the updated launch
date for the COVID-19 Risk Test once confirmed between GTG, IBX and
their telehealth partner.
- Regulators include the Centres for
Medicare and Medicaid Services / Clinical Laboratory Improvement
Amendments (CMS/CLIA) and New York State Department of Health
(NYSDOH)/Clinical Laboratory Evaluation Program (CLEP).
For COVID-19 testing, we are following a policy March 2020 FDA
policy allowing laboratories to initiate patient testing once the
assay has been:
- Validated and approved by the laboratory director/ responsible
Certificate of Qualification Holder; and
- Submitted to CLEP via hard copy and digital.
- COVID-19 Risk Test availability within expanded markets outside
of the United States subject to regulatory approvals for each
region.
Authorised by the Board of Genetic Technologies
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.gtglabs.com
About Infinity BiologiX LLC
Infinity BiologiX (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 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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