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SureScreen Dx Antigen Test Moves to Forefront of UK Effort to Control Spread of COVID-19

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NEW YORK – As part of an effort to try to contain the spread of the coronavirus, SureScreen Diagnostics, a Derby, UK-based diagnostics manufacturer, will deliver 2 million lateral flow antigen tests to the UK government for use in mass testing this month.

The agreement reached by the two parties comes as SARS-CoV-2 has spread rapidly and widely throughout the country and a new, highly contagious variant of the virus has been isolated there. 

Amelia Worley, a representative for the UK Department of Health and Social Care, said that the government ordered the tests from SureScreen to "ensure a reliable supply" of rapid antigen tests going forward. She noted that such assays are already in use in a number of settings across the UK. 

SureScreen's test will be deployed in educational settings, she noted, as well as for the testing of National Health Service and care home, or nursing home, staff. Enabling the surveillance of health and care workers will allow them to "continue their vital work through the pandemic," Worley noted.

The UK government announced the order for SureScreen's tests on Jan. 10. In its statement, DHSC said that the procurement of the assays would allow the regular testing of asymptomatic patients at all 317 local health authorities in the UK with a focus on those who are unable to work from home during the current lockdown, which began on Nov. 5, 2020, the third lockdown the island country has experienced since the pandemic began in late 2019.

UK DHSC also said that NHS Test and Trace, the national service designed to track and control the spread of SARS-CoV-2, would scale up testing of its workforce using the new tests.

A selling point for SureScreen's test is its rapid turnaround time. The lateral flow antigen test can provide results in about 15 minutes. It relies on swabs collected from a patient's nose or throat, which is then introduced into a test cassette by suspension in a buffer solution, and can be read either visually, or via an electronic reader.

According to David Campbell, a director at SureScreen, the company has extensive experience in designing lateral flow assays, including for infectious diseases, and had worked on Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) in the past that served as a basis for its initial work on SARS-CoV-2. The company introduced an antibody test for SARS-CoV-2 in the early spring, and then continued to work on its antigen assay, which it launched in October.

Both assays are CE-IVD marked and have been cleared for clinical use by the UK Medicines and Healthcare Products Regulatory Agency, which is responsible for regulating tests in the UK.

"Our history with building tests allowed us to already have a platform to build up," noted Campbell. "We had done some work on SARS and MERS previously in terms of developing flow tests, so when we started hearing about COVID-19, we thought it would be a similar situation," he said. "We were quite quick to market with an antibody test initially just because of that prior work we were able to do." 

At 25 years old this year, SureScreen is something of a family business. David Campbell's father, Jim Campbell, founded the company and is the managing director. Alastair Campbell, David's brother, is also a director at the firm, which currently employs around 250 people. Over the past few decades, the company has built up a roster of diverse clients to accompany its growing menu of tests, including the maritime industry as well as security services and prisons.

"The thing with diagnostics is there are so many places they can be applied and be very beneficial," said Campbell. "We supply a number of logistics companies that have sea freight and also a number of cruise liners, as well," he said. These clients typically use glucose and urinalysis tests as well as infectious disease assays. They also use the company's drugs-of-abuse assays, which are also popular in the prison sector, where they are part of voluntary and mandatory testing programs. 

As such, SureScreen was well prepared to handle an order of 2 million kits. "We are quite used to supplying contract tenders," noted Campbell. "We have shipped our COVID-19 products to over 50 countries around the world and are quite used to producing in volume." Campbell declined to discuss pricing for the assay, but said it was "an affordable test with a mid-range price."

The winter plan

Beyond the current order, the UK government said in its Jan. 10 statement that it will likely order "millions more" in coming months from SureScreen. The government also said it decided to order from SureScreen as having a British manufacturer "provides greater certainty that we will be able to continue to grow our supply of these important tests."

The tests are being made available for testing of asymptomatic individuals as part of the NHS's Winter Plan, which was published in November. According to the World Health Organization, there have been 3.5 million confirmed cases of COVID-19 in the UK since the pandemic began, as well as 90,000 deaths, with nearly 315,000 new cases confirmed in the past seven days. Given this ongoing, acute need, the government has decided to make lateral flow tests, like SureScreen's a cornerstone of its response strategy.

"Lateral flow devices are already available at significant scale, and so are the focus of our near-term expansion of rapid testing," the NHS said in its Winter Plan. NHS patient-facing staff, care home staff and residents, food manufacturing plans, prisons and asylums, and vaccine testing staff in particular should benefit from this expansion in testing. Schools, colleges, and universities are also being targeted. As part of the plan, NHS Test and Trace received an additional £7 billion (about $9.6 billion) to bolster its efforts through the winter months.  

The UK is also dealing with a new variant of SARS-CoV-2, called B.1.17, which is suspected of being more contagious, though not more lethal. According to SureScreen's Campbell, the company's antigen test has undergone a validation process for the new variant and "was found to perform very well." He said the firm has been trying to access samples containing a Brazilian variant, called P.1, as well as a South African variant, called 501Y.V2. Both are associated with increased infectivity.

Campbell said the SureScreen does not foresee any issues related to detecting SARS-CoV-2 in asymptomatic patients infected with these emerging strains of the virus.

While the company works to serve the market for SARS-CoV-2 testing, it has other products in its pipeline. Campbell said the firm has developed an electrochemical device that can diagnose the quantity of alcohol in a finger prick blood sample within 3 minutes.

"This is critical for [accident and emergency] and ambulance services that most often rely on the lab blood alcohol results which can take 2 hours to get back," said Campbell. "Breathalyzer tests aren't practical in this environment due to patients often being unable to provide a sample."

Originally slated for release last year, Campbell said the product launch was delayed because of the pandemic. He said the product, which is called Alcostick, should launch by summer 2021.