Clinical Testing Laboratories Could Benefit from the Growing Home Testing Market

AUSTIN, Texas - Sept. 9, 2024 - PRLog -- Changing Attitudes Towards Personal Healthcare Decisions are Driving a Surging Home Self-Testing Market

The home healthcare and wellness self-testing market is surging, with some analysts predicting the total market will expand from nearly $11.5 billion in worldwide sales in 2024 to just over $21 billion by 2033.

What's the reason for the rapid growth?

There may be several factors at play, starting with changed attitudes toward "taking control" over personal healthcare and wellness decisions that began with COVID-19.

The pandemic helped people become more comfortable with relying on in-home testing kits for detecting the Covid virus instead of visiting a clinic in person.

Unfortunately, the pandemic may have also encouraged increasing skepticism towards "big medicine" – including traditional doctors. Additionally, among some consumers, there is also a newfound prejudice against public health recommendations, such as taking recommended vaccines or wearing masks.

Instead of turning to a doctor's care, many people are looking for healthcare advice online, including seeking the advice of the growing number of healthcare and wellness influencers. For example, Dr. Eric Berg, a chiropractor and Scientologist who is noted for his trademarks "The Knowledge Doc™" and "Healthy Keto®," has over 12 million YouTube subscribers who seek out his online nutrition and supplement advice and also purchase products from his online store.

FDA Created a Regulatory "Loophole" for Single Clinic Laboratory Testing. Will it Close the Barn Door Again?

While prescribed medicines and medical procedures remain highly regulated by the FDA, there is a regulatory gap in two key areas governing home healthcare and lab tests.

The first gap is that products and tests whose use is classified "for wellness purposes only" are not currently regulated by the FDA. This distinction allows many personal devices (from trendy Oura rings to Fitbits) to escape the FDA's regulatory oversight governing medical devices.

The second gap has to do with a waiver exception created by the FDA in 1988 as part of Clinical Laboratory Improvement Amendments (CLIA) regulations. The CLIA rules categorize different laboratory tests according to a complexity scorecard, which offers waivers to many simple self-administered tests or tests performed by single laboratories (known as laboratory-developed tests, or LDTs).

These two gaps have allowed many of the home tests described below a safe harbor to operate.

Changes to These FDA Waivers are Coming, However.

In April 2024, the FDA announced it had finalized a new regulation governing laboratory-developed tests (LDTs).

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