FDA Approvals for At-Home COVID-19 Testing

Jun 19, 2020 | Blog


Issue #59. Friday, June 19

Hello Everyone,

For this edition of the Zoic newsletter, we’ll still be looking at a few more trends for COVID-19 diagnostics, as well as other fields that we are still keeping an eye on. As we have talked about before, we have seen that investments are still going forward, and well-run startups with enough runway are still proceeding along their development plans, even clinical trials.

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Deal Flow News & Insights

FDA Approvals For At-Home COVID-19 Testing

We have previously discussed the limited number of at-home or self-administered COVD tests available. So far, the FDA has only approved a few amid concerns that self-gathering the sample needs to be reliable. There are ways in which new technology in sample collection can improve this. When it does, it is actually found the self-administered tests are actually more effective and comfortable. This is great news potentially for increasing the number of tests done, but also for future at-home testing for any similar diagnostic, which can span from cold and flu to other infectious diseases.
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On the same topic, the FDA did recently approve another at-home specimen collection kit, this time from Quest. The large lab companies such as Labcorp and Quest have put together, in a short time, these self-administered testing kits even though the testing itself is done at a central lab. One positive benefit to these developments is the advancement of these technologies and approvals, as mentioned previously. The field had been neglected for quite some time as it was assumed that sample collection could always be done at a clinic. However, that assumption was limiting the development and implementation of some at-home diagnostic technologies that could be used instead of a central lab.
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In other deals, we continue to follow technologies in the diagnostic space. We still see quite a bit of activity in the mental health space, particularly with diagnostics. At the moment, the only accurate diagnostics require the use of large and expensive machines such as MRIs, CTs, and PETs. Taking the same accuracy but greatly reducing the cost and complexity will allow for more continuous, at-home testing. This will mean earlier and more effective intervention that is not as costly and without the side effects of later stage therapies such as surgery or pharmaceuticals. For example, the retina is seen as a literal “window into the soul” that allows a non-invasive diagnostic to find conditions such as eye conditions all the way to Alzheimer’s. A company just received FDA clearance for such a retina imaging system. This will be used to diagnose eye conditions like macular degeneration, but such a system can be used to find other biomarkers that are early indicators of more systemic conditions.
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In a similar space, home-based diagnostics are also increasing in interest. There had already been a strong focus, as this allows physicians to more closely monitor patients while they are at home, particularly high-risk patients with a comorbidity or recovering from an incident. This interest has only increased with the pandemic, as even office medical visits are discouraged. For example, monitoring of stroke patients is critical, as a continuous monitoring can show a patients progress (or lack thereof) as well as the progress from a particular treatment regiment. A startup recently received breakthrough designation for such a system. A true platform in this space could also be used for other conditions, such as monitoring from traumatic brain injury or even diagnostics for mental conditions such as schizophrenia or depression.
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Also in the same space, much of the limitations for implementing such an at-home system is the hardware – specifically the ability to non-invasively, yet accurately measure brain wave activity with an inexpensive, light device. Current EEG leads require attachment to bare skin and to a large device, requiring the patient to be immobile. A new system shows that advances in technology can potentially replace this current system with something much more like simple headwear, making at-home monitoring a possibility.
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What We’re Reading
Results from the VC & Founder COVID-19 Sentiment Survey, Part I
Results from the VC & Founder COVID-19 Sentiment Survey, Part II
 Cowboy Ventures
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Connect With Zoic Capital
The Biweekly Dealflow Update, curated by the team at Zoic Capital.

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