GENE stock rose more than 50% in morning trade on July 15, 2020, after the company released an update on its COVID-19 disease severity test.

Molecular diagnostics company Genetic Technologies Ltd (ASX: GTG; NASDAQ: GENE, “Company”), provides the following update to the market on the development of the Company’s COVID-19 Severity Risk Test.

Genetic Technologies 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 COVID-19 virus. The test is intended to predict ‘disease severity’ using a combination of genetic and clinical information.

Highlights:

  • Genetic Technologies has filed a provisional patent for its COVID-19 Severity Risk Test with the Patent Office in Australia
  • The COVID-19 Severity Risk Test comprises a polygenic risk test (PRS) and assessment for clinical risk factors
  • Genetic Technologies has completed the design and request for initial production of the SNP (Single Nucleotide Polymorphism) panel required to process the polygenic risk test portion of the COVID-19 Severity Risk Test from US-based Thermo Fisher Scientific
  • Genetic Technologies has confirmed with major manufacturers that the COVID-19 Severity Risk Test, including a reagent and SNP panel, is capable of being rolled out on a large scale
  • Discussions held with Centres for Medicare and Medicaid Services (CMS) and National Association of testing Authorities, Australia (“NATA”) for regulatory Approval for the COVID-19 Severity Risk Test in the United States and Australia
  • First successful working prototype developed on a data sample of approximately 3,000 patients
  • Options for clinical risk model currently being evaluated
  • The Company is in discussions with several international biobanks and clinical laboratories to source an independent cross-validation dataset
  • The Company has established strong relationships with international biobanks that enable them to secure additional, current COVID-19 patient data to continuously refine the COVID-19 Severity Risk Test. This data is crucial to the completion of the development and validation of the COVID-19 Severity Risk Test.

Genetic Technologies has commenced ordering its first SNP array panel from US-based Thermo Fisher Scientific, the world leader in genetic testing and Genetic Technologies’ manufacturing partner for GeneType products. The SNP array panel is a key reagent that is required to process the polygenic risk test portion of the COVID-19 Severity Risk Test, which is intended to categorize individuals as being of high, average or low risk of developing life-threatening conditions due to COVID-19.

“We see ourselves playing a very important part in responding to COVID-19 and we’re moving quickly to mobilise our partners to develop the right tools and technology to manage this pandemic,” said Genetic Technologies Chief Executive Officer Dr George Muchnicki. “We believe that the COVID-19 Severity Risk Test has the potential to play a critical role in how companies, governments and entire countries understand and manage preventative protocols moving forward.”

Furthermore, Genetic Technologies has confirmed capacity to scale up production for a global-roll out of the COVID-19 Severity Risk Test (reagent and SNP array panel) with major manufacturers, including Thermo Fisher Scientific. The product uses technical components that are already being produced by healthcare manufacturers for other genetic-based tests, which will support the Company’s plans to accelerate production to meet anticipated global demand. Genetic Technologies’ Australian facilities will have the capacity of producing up to 250,000 tests per year. The scale-up of manufacturing will require global distribution partnerships if COVID-19 Severity Risk Test is widely adopted.

In anticipation of high demand, Genetic Technology expects to make its data pack for the COVID-19 Severity Risk Test available to global labs.

Discussions held with Centres for Medicare and Medicaid Services (CMS) and National Association of Testing Authorities, Australia (“NATA”) for regulatory Approval for COVID-19 Severity Risk Test in the United States and Australia.

  • A complete technical package will be submitted to the Centres for Medicare and Medicaid Services (CMS) for review and approval
  • Clinical Laboratory Improvement Amendments (CLIA) turn-around time for approval expected to be approximately 45 days from submission
  • The submission of the technical file to include scientific literature, algorithm validation, lab wet-work validation and laboratory procedural documentation
  • NATA assessment to be provided upon internal review of final independent data set for test validation
  • Intended Use

“The COVID-19 Severity Risk Test can play a critical role for many healthcare systems as they work through their pandemic management plans over the next year,” said Dr Muchnicki.

“We expect that the COVID-19 Severity Risk Test, once fully developed and distributed, will ultimately support public health initiatives globally and that all countries will benefit from deploying the 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
  • Providing risk stratification to prioritize vaccination if and when a vaccine becomes available
  • “While scientists move forward with developing a vaccine for coronavirus, the COVID-19 Severity Risk Test is intended to empower individuals, their employers and governments by identifying personalized preventative protocols for each person as they navigate shifting restrictions and best public health practices,” said Dr Muchnicki.

“If and when a vaccine is created, governments will benefit from having a strong understanding of risk stratification for COVID-19 in their populations to assist with resourcing. There will be a category of people who are at high risk of life-threatening complications should they contract the virus. If they are identified beforehand, those most at risk can be prioritized to receive the vaccine.”

Genetic Technologies has filed a provisional patent for its COVID-19 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 (Single Nucleotide Polymorphism) 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 Severity Risk Test.

“The Company holds an existing patent for the GeneType platform (polygenic risk test and clinical risk factors) that is the base of two genetic testing products already available in the USA and Australia,” said Dr Muchnicki. “The COVID-19 Severity Risk Test uses the same platform, which gives the Company confidence that the test contained in the provisional patent for the COVID-19-specific model will be successful.”

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