The Rise Of At-Home Lab Tests

If I had to name which futuristic healthcare innovations are the easiest to put into practice now that can really make a difference in people’s lives today, I’d say one of those is definitely at-home testing. Having access to a wide range of analyses determining our lab markers and blood results without the wait at the doctor’s, at the lab, and without even meeting anyone… Sounds great. Not to mention that it’s already in the existing testing kits. We just need to use all these in a more systematic way.

Pregnancy tests or finger-prick diabetes tests, for example, were game-changers. They are easy to use and about 100 per cent accurate. A handful of other tests can do the same, delivering results with efficiency and ease. But there’s a vast difference between knowing if you’re pregnant or not and analysing your own genetic test results.

Although there was a lot of professional criticism towards taking tests at home, with the pandemic all that has changed. The pandemic led to a situation where it suddenly became advantageous to do certain lab tests at home to avoid exposure to the infection. On top of that, the pandemic also led to the development of interesting new testing methods, like breathalysers, cough analysing phone apps and skin-patch tests. Not all of these delivered the promise, but the field is buzzing.

Over-the-counter (OTC) tests vs direct-to-consumer (DTC) tests

There is an important difference. OTC tests are like pregnancy or COVID tests we can buy pretty much everywhere, taking the test at home and getting an immediate reading. Direct-to-consumer tests, which represent the majority of the examples mentioned in the article are different: although we take the sample ourselves at home, the specimen is sent to a certified laboratory, where it is analysed by professionals with professional equipment, and we, consumers, will receive the results directly from the lab. The latter becomes available in a number of areas that previously required the physicians’ order to make the test happen, and us to go to a specific place where the test was administered.

At-home science

Over the past few years, I’ve tried and used many tests that used to be only available in laboratories: Microbiome test helped refine my diet. My whole genome sequencing analysis and a BRCA-focused genetic test encouraged me to design a preventive plan with my primary care physician. She also took notes when I provided her with my medication sensitivity genetic test (MyDNA) results. 

I’ve tried the Nima sensor to search for gluten and peanut content in food just for the sake of trying the technology and did a celiac disease test (Imaware) to confirm that I am indeed not sensitive to gluten. I’m awaiting my results from FoodMarble on intolerance for fructose and lactose and even did Genetic Ancestry by National Geographic to find out about my ancestors and where they are coming from.

One can say I have vast knowledge about at-home testing and speak from experience. And I can say that many of these companies did not discover new tests or invent new technologies – but they built accessible, sleek and innovative technologies or devices to let people access testing.

Is testing at home reliable enough?

EverlyWell and other companies like LetsGetChecked, MyLabBox or 23andme provide tools to make lab tests at home, aiming to be faster and cheaper than official laboratories. On top of these advantages, many of these companies also provide support or treatment via telemedicine, so if you ever test positive, help is often included in the test price. 

At-home tests

After the fall of Theranos, testing companies had to fight for their trustworthiness and accuracy big time. We touched the base of their issues in an earlier article on blood testing, but my original conclusion there, that “point-of-care, as well as home lab testing, will be the most significant advancement in the field – completely changing the methods used in primary care and diagnostics” is still a utopia instead of our everyday reality. So what’s missing?

How will it make its way to clinical practice?

Although DTC tests might seem like a niche game for geeks, they in fact have profound benefits. A great example of how these might make their way to clinical practice is the collaboration between digital health platform PocDoc and pharmacy chain Dears in Scotland. The pharmacy chain – with over half a million customers per year – offers on-site cholesterol level testing via the PocDoc app and will prescribe the necessary drugs in real-time within 12 hours of testing on-site. As 1 in every 8 Scot is living with heart disease, making testing that easy – no need to make hospital appointments, no need to travel, no waiting for the results – can make a real difference.

And so much more to come!

The future of at-home testing will drastically change in the coming years. One exciting example is this microsensor that can perform real-time measurements of stress hormones from one drop of blood. The technology aims to help patients measure the natural changes in cortisol levels and monitor trends over time, without having to send blood samples to a lab.

Pros and Cons

At-home laboratory testing has its obvious advantages. One can have multiple important tests without even leaving the apartment. It’s private and convenient, moreover, such tests can remove a serious burden off the shoulders of healthcare systems. In the U.S., these can also become the first step for uninsured Americans to finally access healthcare. 

On the other end, red tape from medical professionals is one of the hurdles for at-home tests. They claim that such tests are likely to be wrong simply because they are tested wrong. Many of these tests won’t require an FDA approval either, and that obviously adds to the uncertainty around them. Some have scientific issues where some experts disagree with the testing methods and others don’t.

Further, in some cases, test results must consider factors like age, family history or other health issues of the patient before evaluation. So you’d probably still need a doctor to help you understand the outcome.

From Theranos to home lab test kits

Almost exactly 7 years ago, in June 2015, Julia Cheek, who was, in her words “probably the least qualified person to start a healthcare startup” grounded a company focusing on at-home lab tests. Remember: this was the year when controversial blood-testing startup Theranos was named the ‘2015 Bioscience Company of the Year’ by the Arizona BioIndustry Association. (At that time nothing was (publicly) known of the shortcomings of this firm.) The two companies at first seem similar in offering affordable lab tests for Americans. However, their disparities are bigger.

Theranos CEO Elizabeth Holmes has failed to deliver the technology she based her entire company on. A California jury found her guilty on four charges of fraud and conspiring to defraud private investors. She is to be sentenced in September, facing up to 20 years in jail.

Cheek’s company, EverlyWell has received an FDA approval for its COVID-19 test tools. The main difference? How the two tried to approach the same problem differently.

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