News
Relay, Fio to add COVID-19 testing to Fio's data device
2020-05-15 16:15 ET - News Release
Mr. Clark Kent reports
RELAY MEDICAL AND FIO CORPORATION ANNOUNCE THE SIGNING OF MOU AGREEMENT TO COLLABORATE ON A RAPID DIAGNOSTIC TESTING PLATFORM
Relay Medical Corp. and Fio Corp. have signed a memorandum of understanding to define a mutually beneficial collaboration to accelerate the enhancement of Fio's data-device platform as a COVID-19 testing, data collection and reporting platform.
Under the terms of the agreement, Relay will provide expertise in medical technology development and commercialization as well as the integration of compatible and complementary assets from its portfolio, including HemoPalm Corp. and Pharmatrac technologies, to enhance Fio's data-device platform for COVID-19 testing regimes using third party rapid diagnostic tests (RDT). Fio's technology has been proven for community-based RDT testing, triage and tracking to manage outbreaks of high-consequence infectious diseases, such as malaria, HIV, dengue and others.
The objective of the MOU is for the companies to jointly form a plan and partnership for the rapid expansion of Fio's platform to encompass multiple emerging COVID-19 tests. The companies will assess and establish a collective infrastructure for the advancement and pursuit of commercial opportunities related to the project with the intent to execute a definitive agreement within 60 days from signing.
During the MOU period, both companies will allocate resources to the project and Relay will provide development resources including its extensive expertise in medical-device development, regulatory strategy, diagnostics, software and artificial intelligence, project management, and its lab, workshop and office space to support the growing operational requirements of the partnership.
"The COVID-19 situation will evolve -- new and more tests, new triage procedures, new treatments, and ups and downs in threat patterns. In this time, a safe return to social and economic life can be accomplished only by new, rapid and flexible technological responses. This requires companies to combine capabilities for a common purpose, which is what Relay and Fio are doing," said Dr. Michael Greenberg, chief executive officer of Fio.
"It is clear that COVID-19 will continue to present multiple health care challenges before we move into the next phase of recovery and we are very excited to participate in the delivery of a meaningful technological solution to potentially give individuals, families and governments the confidence required to return to day-to-day life, and do so safely as we continue to fight the pandemic," said Yoav Raiter, CEO of Relay Medical.
"Fio's data-device platform, Fionet, offers an elegant and powerful way to solve many COVID-19 testing problems, from the administration of efficient serological surveys that enable public health decision making, to the practical assurance of biosecurity at work, public and educational facilities. Relay's HemoPalm team looks forward to working with Fio to create optimized solutions for these challenges," said Paul Glavina, vice-president of in vitro diagnostics for Relay Medical.
On April 29, 2020, Fio, with Relay as a joint venture partner, filed a proposal to Innovative Solutions Canada through the COVID-19 testing stream call for proposals for a grant to test a jointly developed COVID-19 antibody testing platform with a federal government organization.
Need for distributed COVID-19 testing using RDTs
Rapid diagnostic tests are being developed for active infections targeting antigens of the COVID-19 virus, and for detecting past infections and immune response by detecting the presence of specific antibodies. These tests are typically lateral flow rapid diagnostic strips, similar to an over-the-counter pregnancy test, and offer low-cost and simple operation, and can be manufactured at high volumes. However, such tests suffer from several issues including lack of automation and a requirement for visual human interpretation to determine the outcome. In a mass testing regime, manual interpretation can have significantly high error rates, and documenting and communicating the results is not streamlined and is subject to transcription errors. Given the importance of the data, tools that can help reduce error rates, automate interpretation and collate results are needed to facilitate safe and effective mass testing of the population for disease presence and exposure.
Fio's platform enables distributed testing and automated aggregation of diagnostic data from multiple diagnostic devices that can support public health decisions with accurate, real-time data. Its components are:
- Fio Deki mobile device:
- A rugged mobile RDT reader that improves diagnostic quality and testing accuracy;
- Includes procedures and protocols for running approved RDT tests;
- Machine interpretation of RDT tests;
- Compatible with third party diagnostic tests, devices and laboratory instruments;
- Real-time data capture and geotagging.
- Fionet Cloud:
- Device connectivity even in areas with poor connectivity;
- Seamless data exchange with third party health databases;
- Secure, encrypted storage of private health data;
- Remote updating of protocols and software to Fio mobile devices.
- Fionet on-line portal:
- Oversight of testing results and protocol adherence;
- Intervention planning with real-time, anonymous epidemiological data;
- Track and evaluate resource allocation and efficiency.
The company's platform has been deployed in 12 countries where front-line health care workers have benefited one million patients for testing, triage and management of diseases such as malaria and HIV. The information collected from these health visits resulted in over 50 million data points that were available in near real time for public health managers. With Fionet, public health authorities were able to reduce diagnostic errors, ensure correct testing and clinical procedures, monitor performance, capture data, and support supply chain management.
COVID-19 pandemic adaptation
Fio and Relay's collective aim is to offer a system that is automated and ready to perform mass distributed testing, triage and tracking for COVID-19 organized by public health agencies and private-sector companies. This will require efforts to customize the Fio platform for specific COVID-19 approved third party RTDs and ensure that the device is compliant with Food and Drug Administration, Health Canada and other medical device standards. Innovations are envisioned to expand the software's security, workflow, throughput and data capture for mass serological surveillance programs.
The companies are not making any express or implied claims that its product has the ability to eliminate, cure or contain COVID-19 at this time.
About Relay Medical Corp.
Relay Medical is a medical technology innovation company headquartered in Toronto, focused on the development of novel technologies in the diagnostics and artificial intelligence data science sectors.
We seek Safe Harbor.