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MedTech Outlook | Thursday, November 03, 2022
As increasing technological advancements continue to play a key role in diagnosis and supporting physicians and patients, there will be more innovation in the IVD ecosystem, highlighting a promising future for IVD.
FREMONT, CA:In-vitro diagnostics (IVD) is expecting massive growth in the near future. Many studies reveal that the development of condition-specific markers and tests, the growing significance of companion diagnostics, and point-of-care (POC) tests with multiplexing capabilities will offer considerable growth opportunities in the coming years.
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Software such as medical devices and microarrays is an opportunity for IVD companies. For example, the advancements in the last two decades using microfluidic technologies, next-generation sequencing, and microarrays like using one plate to analyse a person's genres with limited effort and time. Today, there is an increasing focus on precision medicine as companion diagnostics in monitoring and identifying therapeutic drug response, and the industry is now at a stage where it is easy to predict future outcomes and prognoses of cancer and genetic disorders.
The technological advancements enable the industry to move beyond the diagnosis stage. The IVD sector now plays a vital role in identifying and diagnosing symptoms, inpatient monitoring, personalised medicine, hospital management, and supporting physicians, clinicians, and patients.
In terms of sensitivity and specificity enhancement, there is no one-size-fits-all approach. Some tests will have low sensitivity, and others will have low specificity. While the latest technologies, such as molecular diagnostics, have high specificity and sensitivity for other types of rapid tests, there is space for improvement, particularly in tests used for confirmatory purposes. For example, in many countries, POC tests are recommended for disease identification and not for disease confirmation. However, with high sensitivity and specificity, it can be recommended for confirmatory, and no follow-up is required.
Research indicates that most of the errors occur at either the pre-analytical stage or the post-analytical stage. Nonetheless, there are some pre-analytical factors that manufacturers address. This includes avoiding the misplacement of sample tubes by barcoding the tubes and ensuring the stability of the specimen during transportation by adhering to guidelines. There is no complete standardisation approach for improving specificity and sensitivity. Much effort is seen in research and development for analytical validation and verifications following international standards.
Currently, laboratory identification tests are expensive compared to routine diagnostics, and there is a need to balance the test costs and produce accurate results for the patient. Manufacturers and laboratories initiate several steps to make molecular diagnostics more affordable. For example, manufacturers consider multiplexing capabilities provision and high throughput of samples, process optimization through automation and lean manufacturing, and open system utilisation, allowing customers and laboratories to select their reagent choice and kit to reduce test cost.
On the other hand, laboratories help reduce costs by optimising the capital equipment costs by taking a higher sample volume load of equipment. They are also aware of the timeframe for holding the samples and have added this into their standard operating procedures and are considering a POC molecular diagnostic test for a better turnaround time. Overall, there is more innovation in the IVD domain as increasing technological advancements continue to play an integral role in diagnosis, assisting physicians and patients.
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