Exhalation Technology Launch Clinical Trial for CoronaCheck™ – A Rapid Covid-19 Diagnostic Test


Cambridge, England, 2 November 2020 – Exhalation Technology (ETL), a Cambridge, UK-based company, announced the start of a large clinical study on humans with its novel CoronaCheck™ diagnostic test for Covid-19 in exhaled breath condensate (EBC). This is a rapid test (aims for a result in under 5 minutes) of high specificity and sensitivity for Covid-19, meeting the need for efficient and accurate testing in a wide range of environments including hospitals, airports, retail outlets, schools and similar spaces.

ETL have developed CoronaCheck™, a rapid antigen test for Covid-19 virus, exploiting their expertise in exhaled breath diagnostics.


Before the initiation of clinical trials in the UK, CoronaCheck™ has shown very promising results on the laboratory bench:

  • It is able to detect as few as <1.5 copies of virus per µl EBC; infected patients are expected to exhale >20 copies per µl

  • Test sensitivity is as great as 100% and specificity >90% at test time which aims to be under 5 minutes, yielding a rapid result at point of care

  • CoronaCheck™ has been tested with live virus as well as in inactivated virus, and in controlled solutions as well as in “virus-spiked” Exhaled Breath Condensate (EBC)

  • Tests with UV-inactivated influenza virus shows that CoronaCheck™ can distinguish between Covid-19 and other viruses such as seasonal flu

  • Embedded Bluetooth functionality in CoronaCheck™ enables rapid reporting of results to healthcare authorities and other interested bodies

ETL has announced today that it has opened its human clinical trial program for CoronaCheck™ at the Clinic for Respiratory Medicine based in The Queen Alexandra Hospital, Portsmouth, headed by professor Anoop Chauhan. This will enable a cohort of 300 patients to be tested in a blinded, ethics-approved clinical trial on infected and normal patients; data on up to 150 patients will be available mid Nov 2020.

Exhalation Technology (“ETL”) seeks a global strategic partner with which it can collaborate to exploit its new Covid-19 test. ETL has a strong history in development of diagnostic products based on analysis of the respiratory tract where Covid-19 is prevalent.

ETL has developed CoronaCheck™, a very unique and timely, IP-protected test for rapid detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 also known as Covid-19), using a novel biosensor housed in a safe breath analysis device suitable for rapid point-of-care coronavirus testing. The test measures directly the presence of virus in breath, as opposed to antibodies in the blood.

CoronaCheck™ has safety features to prevent cross-infection and contamination, to measure the SARS-CoV-2 virus in exhaled breath.

Helle Funch Nielsen, CEO of ETL, said “Initial results from patients recruited into our clinical study are very promising. Our CoronaCheck™ test is set to provide novel technology for high volume screening of individuals in a range of environments including schools, airports, shopping centers and sporting events, to name but a few. The technology is entirely innovative and our initial test is based on rapid testing in exhaled breath, a simple and convenient means of sample collection. Our collaboration with Imperial College in London and clinical centers in the UK such as the Clinic for Respiratory Medicine based in The Queen Alexandra Hospital, Portsmouth, is providing rapid proving and validation of this novel approach to Covid-19 testing.”

Stig Lytke Brejl, Director of ETL, said “building on an existing CE marked IVD medical device platform is expected to enable a short time to market while at the same time de-risking the project significantly.”

ETL has partnered with a leading biosensor company for development of the Covid-19 specific biosensor with ETL’s device, CoronaCheck™. The initial product to be launched will measure SARS-CoV-2 in exhaled breath condensate with a readout time aiming to be less than 5 minutes time.

The CoronaCheck™ test is aimed to be available at under $10 or £8 per test.

CoronaCheck™ does not require any laboratory equipment or special handling or training. The biosensor is mounted in a test cartridge which is inserted into the device into which the subject breathes with results obtained in minutes, whereupon the test cartridge is safely discarded and the device is ready for a new test cartridge and subject.

For more information about Exhalation Technology and partnering opportunities for its CoronaCheck™ Covid-19 test, please contact:

Dr. Bill Mason The Sage Group The Old Black Barns Lord’s Lane, Ousden CB8 8TX UK Tel: +44 (0) 7785 950134 wtm@sagehealthcare.com


Or


Wayne Pambianchi The Sage Group Inc.

1802 Route 31 North #381 Clinton New Jersey 08809 USA Phone: +1 908 2306170 wpambianchi@sagehealthcare.com


Or


Helle Funch Nielsen Tel: +45 2830 7858 hfn@exhalationtechnology.com

About Exhalation Technology

Exhalation Technology develops breath analysis devices for disease diagnosis, monitoring, and management.

ETL aims to revolutionise respiratory care by providing clinicians the tools they need to provide optimal patient care – with confidence.

By giving clinicians access to information related to underlying causes, ETL can strengthen their decision-making process – and create better outcomes for patients.

Why? Because ETL believe monitoring and managing respiratory diseases should be simple and reliable – for everyone involved. ETL is committed to helping transform the way we diagnose, treat and monitor respiratory diseases.

In improving patient outcomes, we help clinicians meet the challenges and opportunities in an ever-evolving respiratory healthcare world.

Website: https://www.exhalationmedicaltechnology.com/

About The Sage Group, Inc.

The Sage Group Inc. is a leader in the provision of strategic and transactional advice to health care companies in the pharmaceutical, diagnostics, medical device, biotechnology and life science fields. Sage currently maintains offices in USA, Europe, Israel and Japan. Since its founding in 1994, The Sage Group has served more than 200 clients in the US, Europe and Asia, and completed numerous transactions including divestitures, alliances, acquisitions and financings with values ranging from $5 million to $500 million.

The Sage Group is an organization of experienced and successful executives who are committed to the service of the very vital and dynamic health care industry and its investors.

The range of services offered includes:

  • Strategic alliances and licensing/partnering

  • M&A, divestment, buy- and sell- side

  • Global product and technology acquisition searches

  • Strategic assessment and planning

  • Due diligence, technology and molecule assessment, valuation

  • New ventures, interim management

  • Facilitating investment in R&D and/or company equity through introductions, network and brokering

The Sage Group's Principals, each an Executive Director, have been Founders, Chairmen, Presidents, CEO's and COO's of a number of emerging health care companies. These Principals have also held senior level management positions in large multi-national organizations. In addition to their management backgrounds, The Sage Group's Principals also have extensive experience in providing professional management consulting services to healthcare industry clients. All these experiences are being applied by The Sage Group to assist industry participants in these challenging times.


Website: www.sagehealthcare.com

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