Press Release
May 3, 2022
COVID-19 and In Vitro Diagnostics – how it worked

The COVID-19 pandemic has changed the world forever and we have surpassed the two year anniversary since the UK first imposed their lockdown sanctions in the hopes to gain some control over the virus. 

In vitro diagnostic medical devices (IVDs) played a huge role in ensuring the spread of the virus was contained and gave medical advisers and politicians vital data in order to make crucial decisions for the benefit of mankind. But how did it all work?

In vitro diagnostic medical devices are tests performed on human body samples such as saliva, mucus in the nose, urine, sweat or blood. They are used to detect infectious diseases or chronic conditions, monitor the ongoing health of a patient and can help to advise on treatment paths to prevent diseases in combination with the patient’s clinical symptoms.

There are several types of IVDs for COVID-19:

Tests used to diagnose the presence of the COVID-19 virus. These can include nucleic acid amplification tests, antigen tests and breath analysis diagnostic tests.  
Serology/Antibody and Other Adaptive Immune Response Tests: These tests are designed to detect antibodies to COVID-19 or measure immune responses. These types of tests cannot be used to diagnose a current infection.
Tests for Management of COVID-19: Some tests are able to detect biomarkers related to inflammation that can inform patient management decisions once someone has been diagnosed with COVID-19. 
In vitro diagnostic medical devices are far from a new concept for the biotechnology and life sciences industries. They are also not limited to being found in hospital laboratories as we all well know. In fact, you may even have some in your bathroom cabinet at home – some leftover lateral flow tests from when the pandemic was at its height, a typical pregnancy test stick, self-blood glucose monitoring and more. 

This video from MedTech Europe explains it in more detail:

What was different for IVDs with the introduction of COVID-19 was that this was a previously unknown virus that medical professionals had very little information and data about which initiated a government funded response to develop a new testing programme. Way back in March 2020, the government announced plans to work with industry, philanthropy and universities to scale up their testing programme. They announced partnerships with Thermo Fisher Scientific, Amazon, Boots, Royal Mail and top UK universities to boost testing capacity in particular for frontline NHS staff. 

Let’s also not forget the funding that was provided to research and develop the vaccine. On 21st April 2020, a UK government briefing announced the human trial for the vaccine. 

In vitro diagnostic medical devices have never seen so much coverage than in the last two years. Their power is limitless and they have a strong future in modern medicine with vast capabilities and benefits. These include the management of rising antimicrobial resistance, improving early detection of life altering diseases like cancer and increasing availability of personalised medicinal routes for patients who are no longer responding to antibiotics. 

Biophys Ltd hopes that diagnostics remain in the spotlight using their time to demonstrate their value and increase the available funding to continue their life-saving work. Find out more about how we can support biotechnology companies with medical device development here.

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