09 February 2021
Adam Hargreaves By Adam Hargreaves

Diagnostics is Changing to Meet Your Demands.

What do you want from diagnostics?

Before COVID-19, this wouldn’t have been a question at the forefront of so many peoples' minds. However, the global pandemic has shone a spotlight on the healthcare industry and made consumers think about how they interact with the diagnostics market.

Diagnostics has been crucial in the fight against COVID-19, informing people when they need to self-isolate and providing early diagnoses which help save lives.

A lot of this testing has been with at-home self-testing kits, so people can keep safe and avoid visits to testing centres or hospitals where the virus is rife.

Home testing has proven to be quick, easy and effective. For people in countries without free healthcare, it’s also been a lot cheaper too.

This has made consumers question traditional testing methods, which is inconvenient and inflexible – revolving around trips to general practices or hospitals.

We’re Taking Charge of Our Health

People have come to realise that they want access to testing anywhere and anytime.

With this realisation apparent globally, diagnostic companies must adapt if they wish to be successful in this new era of diagnostics. They must improve their consumer experience. They must give people the power to act on their health by offering flexible, convenient access to tests.

While it will be tricky for some companies to adopt the at-home testing model, I expect many to try. After all, there’s so much opportunity in the space.

Already we’ve seen major investment in the at-home testing companies from around the world. A lot of this has been to meet the COVID-19 diagnostics demand. However, as these companies continue to prove the effectiveness of the at-home testing model, more trusting investors are sure to follow.

Meeting the COVID-19 Demand

Everlwell COVID-19 test kit

Everlywell is an established name in the at-home testing space and was quickest off the mark to provide a stand-alone at-home sample collection kit for COVID-19. Working alongside the FDA, the company received emergency-use authorization for its test on 16th May 2020.

The US company has grown rapidly throughout the pandemic. It sold over 500,000 COVID-19 tests throughout 2020 and received $175 million in new funding in December.

With this cash injection, Everlywell plans to expand its virtual care offering, hire more staff and improve its testing infrastructure to accommodate a new wave of at-home test users.

Everlywell is well-placed to cement itself as a market leader in the at-home testing space. Already, it offers over 30 panels including tests for fertility, cholesterol, heart health, STIs, Lyme disease, testosterone, thyroid health and more.

The company has recently been valued at $1.3 billion and is supported by a Scientific Advisory Board that includes some of the nation's top scientists from Harvard, MIT, Google and NYU. They’re in safe hands and undoubtedly going to play a big role in this new era for at-home testing.

LetsGetChecked COVID-19 test kit

LetsGetChecked has also been providing COVID-19 tests from May 2020 and experienced significant growth as a result.

The company began in 2014 with sexual health tests and have since added tests for men and women’s health, plus diagnostics for vitamin levels, thyroid function and cortisol levels. However, it’s the company’s COVID-19 test that’s encouraged its rapid rise.

LetsGetChecked has shipped more than one million coronavirus tests since the beginning of the pandemic, which meant its 2020 sales had an 800% year-on-year growth.

The COVID-19 test follows the same process as the other LetsGetChecked tests. When ordered, the test is shipped for next day delivery, anonymised and assigned a unique barcode that is linked to the patient. It’s tracked from the moment the test leaves facilities, giving patients the power to collect their own sample at a time and place that is comfortable to them.

The test is quick, accurate and uses robotics to process samples with results available in two to five days. Once the sample is processed, LetsGetChecked internal doctors review the results, contact the patient and discuss next steps - which can include advice on lifestyle changes or prescriptions.

This simple, effective process has proven favourable with consumers and LetsGetChecked is offers exciting growth potential, having opened its Dublin lab to expand its at-home coronavirus testing for Irish customers this February.

Cue Health COVID-19 test kit

Cue Health wasn’t far behind LetsGetChecked and Everlywell in its response to COVID-19. The rapid diagnostics start-up received Emergency Use Authorization for its molecular test for the virus in June.

Cue Health has played a major part of the US’ plans to combat the pandemic. In October 2020, the company was awarded $481 million from HHS and the Department of Defense (DoD) to expand production its COVID-19 test and deliver six million tests by March 2021.

This point-of-care test uses a nasal swab sample collected from the lower nose to detect the presence of SARS-CoV-2 RNA. It then transmits its test results from the start-up’s reusable cartridge reader device to the Cue Health App within 20 minutes.

The test is fully automated and designed to be easily administered with minimal training in point-of-care settings. The single-use Cue Cartridges (used with the Cue Sample Wand) contain all the complex biochemistry needed to convert test samples into accurate digital results.

Cue Health’s support during the pandemic has proven the value of its at-home testing platform, which also includes products in women's health, sexual health, respiratory health and more.

Ellume COVID-19 home test app

Like Cue Health, Ellume has received significant from the US government too.

This February, Australian diagnostics company was awarded $230 million by the Biden administration to scale up the manufacturing of its at-home COVID-19 test to support the US.

Ellume’s at-home test - which received emergency use authorisation from the FDA in December - is 95% accurate and provides results within 15 minutes.

The test includes a sterile nasal swab, a dropper, processing fluid and a Bluetooth connected analyser for use with an App on the user’s smartphone. Utilising the dedicated App, the user follows step-by-step instructions to perform the test including a self-collected mid-turbinate swab. The user’s sample is then analysed and results are automatically transmitted to the user’s smartphone via Bluetooth.

As well as delivering results for individual consumers, the test also supports efficient COVID-19 mapping by providing real time reporting of test results and critical data to health authorities, employers and educators through a secure cloud connection.

Thanks to the US’ backing, Ellume will be able to produce 19 million of these testing kits per month by the end of the year – which is a lot more than the 16,000 it used to manufacture per day, when the test was approved in December.

The Impact of COVID-19

All this fantastic work to meet the demand for COVID-19 diagnostics has proven one thing: at-home testing works. Sceptics have been silenced, consumers are engaging with the model and companies are primed to grow within the at-home testing space.

While I’m excited to see how this influences the diagnostics market, I’m also hoping it will have a positive effect on the way that people engage with their health. Diagnostics is on its way to becoming more convenient, flexible and accessible for patients. So, now it’s on us. We must utilise the innovative technology and allow it to provide more early diagnoses around the world. If we continue to engage with at-home testing, it will save so many lives.

If you’re excited about the at-home testing space (like me) and want to have a chat about it, or CM Life Science’s recruitment services, please email at Adam.Hargreaves@lifesci-cm.com.

For more content like this, go to my consultant page.

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Adam Hargreaves

Adam Hargreaves is Principal Consultant specialising within commercial IVD, covering a global market. Adam is a specialist at building teams and making sure new hires culturally align to company goals. Fascinated by his market, Adam is always keen to talk with experts and leading executives on the subjects that matter most to you. 

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