Genetic Technologies (GTG) Signs Multi-Year US Distribution Agreement for COVID Risk Test

March 4, 2021 7:09 AM EST

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Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a diversified Genomics and AI-driven preventative health business is pleased to announce a co-exclusive production and distribution rights and license agreement (‘Agreement’) with US-based Infinity BiologiX LLC (‘IBX’), a leading central laboratory providing sample collection and processing, storage, analytical services, and scientific and technical support, for the production, distribution and sale of the Company’s COVID-19 Serious Disease Risk (sdr) Test (‘COVID-19 Risk Test’) in the United States.

Highlights

  • Initial three-year co-exclusive licence agreement between IBX and GTG for the production, distribution, sales and marketing of GTG’s COVID-19 Risk Test in the US, under the ‘powered by GeneType’ branding
  • IBX is required to make minimum payments to GTG totaling US$2.9 million over the term to maintain exclusivity with an initial upfront payment of US$50k followed by minimum payments totaling US$850k in the first year and US$1.0 million in each of the second and third years1
  • IBX may terminate this agreement at any time and for any reason upon 60 days written notice to GTG with effect upon the expiry of the 60-day period
  • 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
  • Underlying royalty structure is on a per unit basis of US$10
  • IBX will define and decide the sales and end-to-consumer pricing structure for the COVID-19 Risk Test

Genetic Technologies has secured a co-exclusive three-year agreement for the production, sale and distribution of its COVID-19 Risk Test across the United States with IBX, subject to IBX's rights to early termination on 60 days’ notice. The payment structure includes an initial upfront payment of US$50k followed by minimum payments totalling US$850k in the first year and US$1.0 million in each of the second and third years totalling a minimum US$2.9 million to maintain exclusivity.

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.

Simon Morriss, CEO of Genetic Technologies, stated: "We are excited to be partnering with IBX, to enable our COVID-19 Risk Test to be introduced commercially into the COVID-19 product landscape in the US. This agreement is a significant milestone for GTG representing the first multi-year commercial agreement the Company has entered into for the sale and distribution of one of its developed products.

“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. 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.

“We view this initial agreement for the sale and distribution of Genetic Technologies’ COVID-19 Risk Test as a critical collaboration in line with our mission to understand the genetic causes of common, complex diseases and to discover diagnoses, treatments and, eventually, cures for these diseases,” explained Robin Grimwood, IBX Chief Executive Officer, “We are uniquely and strategically positioned with our partners to deliver the test and provide remote telehealth services and reporting, utilizing our extensive array capability and capacity across a number of platforms. We were proud to offer the first COIVD-19 PCR saliva test last spring and now see the Risk Test as an important next step with providing patients with the information they need to make the best decisions possible for their own health, their family’s health and the health of their community.”

Peter Rubinstein, Chairman of GTG stated: “This agreement is a testament to the hard work of the team both at IBX and within GTG who have navigated challenges and a changing landscape to ensure we can deliver this product to market and provide a valuable resource in the fight against COVID-19. We look forward to a long and fruitful relationship with IBX as we collaborate to bring this valuable resource to market in the fight against COVID-19.

“Our head of strategic partnerships, Adam Kramer, was critical in driving this agreement through his strong relationships within IBX and his incredible passion to bring new, innovative, and transformative healthcare technologies and advancements to market.

“We also recognise and applaud the significant contribution of our Scientific Team, headed by Dr Richard Allman, our Medical Team now headed by Dr George Muchnicki and Kathy Koskiris heading our Regulatory Team for their ongoing dedication to refining and improving our COVID-19 Severity Predictor to enable us to be at this critical juncture for the Company.

“We value and recognise the long-term and significant support we have received from our shareholder base throughout these past months and years and are thrilled to be delivering on our strategic objective outlined to the market at the start of this COVID journey.”

The GTG team is in final stages to submit the COVID-19 Risk Test for clearance from Clinical Laboratory Improvement Amendments (CLIA) and will update the market when clearance is received.



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