Thermo Fisher Scientific Inc., the world leader in serving science, officially cut the ribbon on its new $40 million facility in Lenexa, Kansas dedicated to viral transport media (VTM) production. The company is also announcing that the site will continue to expand to meet expected sustained demand for COVID-19 testing. The facility has created more than 300 new full-time jobs and added 120,000 square feet of manufacturing capacity.

In early May, Thermo Fisher received a contract from the U.S. government to provide a significant quantity of highly specialized VTM for COVID-19 sample collection. VTM is dispensed into plastic tubes that are used to safely collect and transport clinical specimens containing viruses. This ensures that the sample collected from a COVID-19 nose swab maintains viability while it is shipped to a lab for testing. Thermo Fisher has responded quickly to meet increased demand for VTM by ramping up production in Lenexa from 50,000 units per week to now more than 8 million per week since the new facility began production in early July.

“Thermo Fisher is proud to support virtually every aspect of the global COVID-19 response and our colleagues in Lenexa have played a key role in those efforts,” said Gianluca Pettiti, senior vice president and president of the company’s Specialty Diagnostics business. “Thanks to their hard work, Lenexa significantly increased production of VTM units. The team has worked with unrelenting intensity to build out and open a new site in just about six weeks. They understood the urgent national need, accepted the challenge and have delivered for the American people.”

Company executives and government leaders, including Governor Laura Kelly, U.S. Senator Jerry Moran and Lenexa City Mayor Michael Boehm, will attend the ribbon cutting and ground-breaking ceremony on August 28. The site will allow for social distancing for the 200 guests expected in attendance.

“Widespread testing is a necessary component to keep the American economy running safely,” said U.S. Senator Jerry Moran. “Thermo Fisher has stepped up to produce additional test tubes to help meet the national demand for COVID-19 testing and has created 300 new jobs by expanding its manufacturing base in Lenexa. Kansans never fail to do their part in our country’s time of need, and this is no different. Thermo Fisher’s ability to manufacture test tubes and significantly increase production is important for making certain Americans can feel secure in their health and safely return to work.”

“I’m grateful to the team at Thermo Fisher for the many ways they’ve stepped up for the health and safety of people in Kansas and across the country,” Governor Laura Kelly said. “This facility will do important work innovating and supporting the tools we have to fight this pandemic. I applaud Thermo Fisher’s commitment to this critical endeavor.”

To ensure accuracy of COVID-19 test results, VTM must be manufactured and dispensed into tubes in an aseptic environment. The new facility is dedicated to accelerating production and ensuring quality control by utilizing the proven blueprint for high-quality VTM production that has been developed in Lenexa. In addition to supporting America’s pandemic response, the products will be used for collection and sampling for flu and other viruses.

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.

Relay Medical Corp. and Fio Corporation announce the signing of U.S. and French distribution partners for the Fionet Mobile COVID-19 testing and tracking platform.

Relay and Fio previously announced a joint venture on August 19, 2020 to rapidly launch and deploy a new COVID-19 testing, data collection and reporting solution. The JV operates under the name “Fionet Rapid Response Group” (FRR) and is headquartered in Toronto, Canada. On August 25, Relay and Fio announced the commencement of FRR operations.

Today, FRR announces that Fio has signed distribution partners in France and in the U.S. to market Fionet to pharmacies and certain other sectors.

Pharmacies are community-based and thereby access the vast majority of the population; they are approximately 10x more numerous than clinics; and France, the UK, and the U.S. have already legalized COVID testing in pharmacies, and other countries are following suit. Pharmacies are well-positioned to deliver effective mass testing and triage and for safe return to work programs.

For example, the U.S. has 67,000 community pharmacies, dwarfing the 7,000 hospitals and community health centers combined. The U.S.’s 175,000 pharmacists are referred to as the most over-trained and under-utilized healthcare professionals in America.(1)

In France, Fionet will be distributed by Magentine, a company set up to distribute Fionet and rapid diagnostic tests (RDTs). In exchange for its marketing rights, Magentine has committed to a minimum order in 2021. Magentine was founded and is headed by Mr. Francois Dupoteau, who previously co-founded a successful in vitro diagnostic company, ECS Prograstrin. In addition to marketing Fionet to pharmacies, Magentine will market Fionet to physicians’ offices.

Fionet is a mobile testing and tracking platform that enables community-based return-to-work programs by performing at hospital-grade accuracy, yet in higher volume, faster-speed, and with less-skilled frontline workers.

Fionet thus enables the controlled expansion of diagnostic testing and triage beyond the few overburdened medical centres to the many community-based settings such as pharmacies, small clinics, workplaces, airports, nursing homes, schools, etc.

The platform combines handheld devices linked to online AI-powered cloud, automating frontline testing and capturing test results for tracking. Rugged, mobile devices are compatible with multiple third-party antigen and antibody COVID-19 rapid diagnostic tests (RDTs), which creates sourcing flexibility for RDTs which are of limited supply and continuously evolving. Fionet also connects with molecular testing devices such as PCRs.

The UK’s Royal Marsden Hospital in London has developed an e-form solution using Hyland OnBase that captures and tracks COVID-19 symptom responses from cancer patients remotely, prior to an appointment or treatment visit.

When the pandemic struck, tech-savvy oncologists at the Royal Marsden Hospital (RMH), which specialises in cancer treatment, wanted to develop a new system to protect cancer patients from COVID-19 exposure. The oncologists asked their CIO, Lisa Emery, to help them develop software to pre-screen patients for the infection, before arrival at hospital, to protect immuno-compromised cancer patients. To pre-screen patients effectively, they needed to know when newly admitted patients tested positive for COVID-19, when patients exhibited symptoms of the disease and when patients came into close contact with someone with the virus. Additionally, the cancer specialists wanted to monitor the health of COVID-19 patients already discharged from hospital.
Manual pre-screening process was labor intensive

A COVID pre-screening questionnaire already existed in paper form at the hospital, but completing it was a labour-intensive, manual process. According to Emery, skilled nurses spent time calling patients to administer the questionnaire, removing them from more pertinent tasks. The right solution would allow RMH to pre-screen patients simply and quickly, allowing nurses to return to more pressing work. It would also empower patients, allowing them to take a more active role in their care.
Collaboration and flexibility produce innovative solution

RMH turned to OnBase, Hyland’s enterprise information platform, to build the solution. Emery and her team suggested transforming the paper questionnaire into a dynamic electronic form, which could check symptoms remotely. As the teams began to collaborate, they reimagined the content of the form. Beyond a simple pre-screening, collected data could, in turn, trigger a response from a nurse cancer specialist to contact the patient, provide reassurance and set up a video-consultation, if necessary. It was imperative that Information could be collected easily and shared quickly.

Automated workflow notifies clinicians of patient needs

The teams also wanted to make sure the software was simple for patients to use as they did not want to overload cancer patients with too many system changes. RMH worked with the Hyland team to create a web portal where patients could easily access and fill out the symptom checker. Patients could provide up-to-date medical information, as well as any COVID-19-specific symptoms they may be experiencing. The answers provided could trigger a specialist response and other clinical intervention. The trigger would arrive via automated workflow and an email would notify the specialists that patients may be in need.
RMH expands symptom checker throughout enterprise

After development and launch, adoption of the remote symptom checker has increased. It is now used to check any patient for COVID-19 symptoms, prior to arrival, for any form of treatment. RMH is now working with several clinical teams and expanding its use of the symptom checker to outpatient clinics as well. The hospital also plans to revisit the technology and apply it to other communicable diseases, like the flu.

NOWDiagnostics, Inc. announced it is working with BARDA, the Biomedical Advanced Research and Development Authority arm of the U.S. Department of Health and Human Services, to develop a serological test for SARS-CoV-2 antibodies that can be used across a variety of health care settings—from clinics to hospital emergency rooms—and ultimately by consumers for at-home use.

The COVID-19 rapid antibody test, using NOWDiagnostics’ self-contained ADEXUSDx® platform, requires no additional materials (reagents and buffers), equipment, processing, or refrigeration. No matter where it is conducted, the ADEXUSDx® COVID-19 Test is designed to deliver lab-quality results in 15 minutes detecting the presence of SARS-CoV-2 antibodies in individuals who have been exposed to the virus. This can include those who have been recently or previously infected with COVID-19, regardless of whether they presented with severe, moderate, mild or no symptoms.

The rapid-results ADEXUSDx® COVID-19 Test requires only a fingerstick to obtain 40 μL of capillary blood, venous whole blood, serum, or plasma and has the potential to be deployed directly in homes and workplaces. Availability of point-of-care (POC) and over-the-counter (OTC) tests would allow individuals to be screened easily and quickly, yielding test results in minutes instead of days. An application for Emergency Use Authorization (EUA) was filed with the Food and Drug Administration (FDA) in May 2020 for moderate complexity use of the ADEXUSDx® COVID-19 Test.

This project has been funded in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00156. BARDA’s support for this project includes funding of $695,500 of the project costs and technical support required for NOWDiagnostics to request Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for POC and OTC uses of the ADEXUSDx® COVID-19 Test.

The information contained in this press release is provided by NOWDiagnostics, Inc. and does not indicate endorsement by the federal government of the company or its products.

NOWDiagnostics, Inc., based in Springdale, Arkansas, is a leader in innovative diagnostics testing. Its proprietary ADEXUSDx® platform features a lab at your fingertip, using a single drop of blood to test for a variety of common conditions, illnesses, and diseases, with results in a matter of minutes. By eliminating the need to send tests to off-site laboratories, NOWDiagnostics products have the potential to decrease the waiting period to determine test results from days to minutes.