EKF secures COVID-19 novel sample collection kit manufacturing and supply contracts

EKF Diagnostics announces it has secured new contracts for manufacturing and supplying a novel, patented sample collection device that allows COVID-19 samples to be rapidly inactivated in the collection tube, avoiding contamination and preserving RNA without refrigeration. To support the increase in COVID-19 testing globally, a safe and easy sample collection and transport mechanism is essential; the PrimeStore® MTM sample collection device provides this.

EKF is a contract manufacturer and supplier for the PrimeStore® MTM, which is an FDA-cleared and CE-marked microbial nucleic acid storage and stabilization device owned and created by Longhorn Vaccines and Diagnostics LLC (Bethesda, Maryland, US). PrimeStore® MTM deactivates viruses, bacteria, fungi, and mycobacterium tuberculosis, allowing safe sample handling and transport and eliminating the risk of infection during transport and in laboratories. In addition to removing the need for cold chain storage of samples, RNA and DNA are perfectly preserved, ready for safe testing immediately on arrival at a laboratory, and without the need for containment. COVID-19 has led to a significant increase in global demand for this unique device, the only FDA Class II-cleared device for microbial nucleic acid storage and stabilization (RNA and DNA) available to safely transport samples that may contain viruses.

In addition to more than doubling its current manufacturing capacity of this device in the US on behalf of Longhorn, EKF has now rapidly repurposed its European manufacturing facilities in Cardiff, UK, and soon Germany. This substantial increase in manufacturing capacity is to meet new US orders and new European supply contracts for PrimeStore® MTM, including an agreement with Source BioScience UK Ltd to be used for its growing COVID-19 testing service.

Source BioScience provides ISO:15189 laboratory testing services for the NHS and private healthcare. It is working with several businesses to provide their staff with COVID-19 testing services to enable them to bring back those who may be self-isolating due to concerns over infection or that of a family member. Using the PrimeStore® MTM transport media significantly removes the cold chain transportation protocol that is necessary for other transport media.

“We are delighted to supply Longhorn’s PrimeStore® MTM collection kits to Source BioScience, a well-established provider of testing services to the NHS. These collection kits will ensure that COVID-19 samples can be handled and transported without expensive refrigeration or fear of contamination,” said Julian Baines, CEO of EKF Diagnostics. “This is a key part of the testing supply chain, which can underpin the safe and rapid increase of testing capacity. In addition to the US, we will continue ramping up our production capacity here in the UK and Europe to meet increasing demand and support efforts to limit the spread of Coronavirus globally.”

Jay LeCoque, Chairman and CEO of Source BioScience, added: “We are very encouraged with this partnership and significant development from EKF, which allows the removal of cold chain transportation, making logistics of samples less expensive and more available to the many hospitals and businesses needing to test key workers and staff regularly. This dramatically expands the reach of COVID-19 testing services to a larger population and will support a faster economic recovery.”

PrimeStore® MTM was invented and patented by Longhorn Vaccines and Diagnostics LLC in 2006 in preparation for a worldwide pandemic and has already been used in testing for many infectious diseases and high consequence pathogens, including influenza, RSV, TB, HIV, and coronavirus. As it inactivates pathogens rapidly and stabilises the RNA for up to four weeks with no requirement for cold storage, this makes the logistics of sample collection less expensive and makes testing more readily available to institutions and businesses that need to test staff regularly. Furthermore, in the case of COVID-19, by inactivating the virus, testing can now take place outside of containment facilities, opening up capacity for more testing laboratories.