Wow, what a year! If we can make it through 2020, we can make it through anything. A year ago today, the thought of bringing healthcare into the home was far-fetched and required a massive behavior change.
As we move into 2021, the country is empowered to take control of their healthcare while living through a pandemic and seeking and adopting healthcare solutions like telemedicine, digital health tools, and at-home diagnostics.
For Checkable Medical, this is the silver lining of COVID-19, the democratization of healthcare. Behaviors and perspectives have shifted, which will significantly impact the adoption cycle of the strep test.
We decided to research and seek approval for the COVID-19 rapid antibody test in conjunction with developing the at-home strep test and digital platform.
Five driving factors determined this decision:
It provided a faster path to revenue.
The COVID-19 product had a shorter regulatory process - the EUA pathway.
It would serve as a launchpad for the Checkable Medical brand to the consumer market.
Clinical research came to a screeching halt except for COVID-19 research, and we seized the opportunity.
We could apply what we learned in the COVID-19 trial to the strep trial.
In December 2020, the FDA approved three rapid at-home antigen tests. These tests’ approvals are extremely promising and indicate the agency’s willingness to approve quality at-home rapid diagnostics. The rapid antibody test provides three data points for consumers, while the antigen and PCR tests only provide one.
The Checkable Medical COVID-19 At-home Rapid Antibody Test market opportunity is massive. We are rapidly developing our launch strategy with a chosen partner while conducting further research; the goal is to be the first at-home approved rapid antibody test.
We continue to receive phone calls and emails from moms who Google "at-home strep test," asking if they can purchase a test. Pediatricians and family medicine physicians overwhelmingly comment on the need and benefits of an at-home strep test.
2020 Highlight Reel
Brought in revenue $$.
Identified and hired a complete team, including quality, engineering, regulatory, design, marketing, and project management roles.
Designed a strep test and built multiple iterations of prototypes.
Identified a manufacturing partner and proven feasibility of COGS targets at volume.
Rebranded and completed box design - Strep + COVID-19 rapid antibody test.
Executed a clinical trial.
Contracted as a CRO for our distribution partner.
Found an assay supplier and analytical test lab.
Designed and coded a telemedicine platform.
Launched our social channels and SEO strategy.
Awarded with several grants and awards.
Want more details? Read on...
At-home Strep Test
The strep platform remains the innovation and core of Checkable Medical. Our focus remains on this product through to approval.
The at-home strep test went from a concept to four designs, narrowed down to one design to 3D printed models, to a prototype in 9 months (and a lot of engineering work!).
In January, we will cut tooling for feasibility trial units and order our packaging samples. The tooling and packaging will allow the engineering team to evaluate the first parts out of the tool. Once completed and validated, we will move to execute our first pilot study of 25 subjects. The pilot study will validate the test design, protocol, and confirm that lay users can collect a throat sample and administer it using the package insert or digital instructions. If design changes aren’t necessary, we can freeze the design and prepare for the clinical trial and execute in late 3Q2021 and 4Q2021.
We are proud to share that Checkable Medical brought in revenue in 2020 as a CRO and distributor of the COVIBLOCK rapid antibody test, and we executed our first clinical trial. We partnered with our distributor and conducted two trials, one for the CLIA waiver for our distributor and the other for the at-home Checkable Medical COVID-19 At-home Rapid Antibody Test.
We will begin a second trial at a research site in Fargo, ND, in January. The data will be supplemental to the current submission and will be used for the 510k application. The goal is EUA approval and e-commerce launch of the at-home test in 2Q2021. Digital Platform The first portion of the digital training component is complete. The "how to take a throat sample" training has been coded and animated, and we're now moving to how to run the test with a timing mechanism. The telemedicine architecture and integration with 3rd party API and AWS is nearing completion.
In Q4 2020, we completed a branding and messaging refresh with our go-to-market partner, The Stable. We engaged with this team because their breadth and depth of offerings span from launch strategy to sales and creative to product positioning and messaging. We had previously created messaging and were aware of our target audience, but The Stable brought confirmation of our assumptions with detailed data and findings.
Follow, like, and subscribe to our social channels (Instagram, Facebook, LinkedIn and Youtube) and share them with your connections. Social media allows small brands like Checkable to test our messaging and understand the organic reach our content has. The more content, the more likes. The more traffic to our site, the better our search rankings will be and, most importantly, conversions when we have a live product.
The convertible note remains open. We were awarded a loan from the State Bank of North Dakota in September, a $10,000 award for Securian Financial’s most Family Friendly Innovation in the MN Cup, and $40,000 from a Federal Cares Act grant from the State of North Dakota.
We wish you and yours a prosperous 2021!
Warmest regards, Patty Post
CEO - Checkable Medical