Seismic Changes are required in order to improve patient outcomes and provide economic benefits for In Vitro Diagnostics

Seismic Changes are required in order to improve patient outcomes and provide economic benefits for  ...

The present state of in vitro diagnostics is no longer fit for purpose. Inadequate procedures leave critical insights often missed, while expenditure statistics on both sides of the Atlantic reveal significant disparity in investment. It''s time to explore the potential of emerging techniques and technologies to help improve the whole area of clinical testing.

We are all working day-to-day on these problems as a result of Cambridge Consultants. Often, the team is working with established companies to develop new clinical diagnostics. Some examples include lateral flow tests that provide instant response with polymerase chain reaction (PCR) sensitivity to determine disease status.

As far as Im concerned, the urge of the last couple of years should not be allowed to decomposed large areas of in vitro diagnostics (IVDs) remain ripe for innovation. Most often, current diagnostics are limited by only being able to provide a snapshot of a single parameter in time. Often, this is a single data point, which might lead to further monitoring. It''s unlikely that you are missing crucial insights.

Discrepancy between value and investment

IVDs inform 70% of all clinical decisions taken, while only 1% of NHS expenditure will be invested in diagnostic testing. This is because of the clear gap between the value of diagnostics and our investment in them.

The 2015 National Academy of Medicine report was absolutely unmistakable. It concluded that healthcare has been delivered for decades without a blind spot: diagnostic errors are widespread in all settings of care and continue to cause damage to an acceptable number of patients. Although diagnostics are not fully appreciated or adequate invested in, however, concerns remain.

At least 5% of US outpatients have a diagnostic error. Six to 17% of adverse events in hospitals are linked to diagnostic errors, which are responsible for 10% of all patient deaths. However, underinvestment will not improve the status quo, and although COVID-19 will not teach us anything, it is that IVD testing is required in the treatment and management of disease. Moreover, IVDs are critical in the evolution of our healthcare system and must be improved in several ways.

These improvements should include:

  • Accessibility democratization testing for all which should include more point of care and testing at home
  • Reduced time to result improved efficiencies from getting a diagnosis to the clinician quicker and even starting the appropriate treatment when the patient is already in a clinical setting
  • Increased accuracy and reduced false positives and negatives
  • Reduced costs and the removal of barriers to use

The development of more robust and accurate IVDs will have a significant impact on the healthcare system in the short term. Early detection fits with the personalized medicine approach, which includes genetic variations in patients, knowing which treatments work and which dont. This has the purpose of preventing the formation of specific diseases and promoting the best treatment if there isnt a treatment to stop the disease.

Continuous patient monitoring

This seismic shift in diagnostics'' role will have significant economic implications and positively impact patient outcomes. However, diagnostics will need to undergo longer periods to ensure that patients are monitored, thus they may transition to continuous monitoring for everyone. Technological advances combining the diagnostic depth and coverage of currently complex molecular diagnostics with easily accessible samples such as sweat and saliva with simple at-home testing might be a viable strategy.

The immediate challenges would be to develop molecular diagnostics that are more sensitive, where the technology can be democratized and doesn''t require expensive hardware. Perhaps it would be directly uploaded to the cloud, and advanced AI can quickly detect changes or abnormalities, without the need for human intervention. All of this data generation will be critical.

Moving from clinical settings to home use and point of care is critical. Here, were making strides to make this much more accessible. Digitization means tests can be taken at home, quickly, when necessary, and the results can be sent to clinicians immediately to make a quick diagnosis and ensure swift appropriate medical treatment. Wearables that offer robust data over a longer period are assisting transition from the single snapshot and the single timepoint analysis.

We are constantly pushing the boundaries of science and engineering, to provide them with the best possible and most effective treatment we can in vitro diagnostics. I believe that with emerging technologies and techniques, the sector can make a real difference in the lives of patients.

About the author:

Andrew Goulter has over 20 years of experience in the life sciences industry, including working in the pharmaceutical industry, in the development of scientific instruments and medical equipment.

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