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Founders Focus

Exact Sciences (EXAS) granted FDA emergency use authorization for COVID-Flu Multiplex Assay

Quotes from the article

There is an FDA-approved/cleared test for the qualitative detection and identification of SARSCoV-2, influenza A virus and influenza B virus (among other organism types), but this is not an adequate and available alternative to your product. Respiratory viral infections caused by the influenza A and B viruses and SARS-CoV-2 can have similar clinical presentation and diagnostic considerations. Thus, to differentially detect SARS-CoV-2, information from a test that detects and differentiates the virus that causes COVID-19 and the common influenza viruses that cause seasonal epidemics of flu, influenza A and B (not influenza C) is needed during the flu season that coincides with the COVID-19 pandemic.

FDA considered the totality of scientific information available in authorizing the emergency use of your product for the indication above.

Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19 through the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus nucleic acids and that the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product; and there is no adequate, approved, and available alternative to the emergency use of your product.

Your product is a real-time RT-PCR assay intended for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus and/or influenza B virus in anterior nasal swab specimens self-collected in a healthcare setting by individuals suspected of respiratory viral infection consistent with COVID-19 by a healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Your product is not intended to detect influenza C virus.

This test is also for use with anterior nasal swab specimens that are (1) self-collected at home by individuals age 18 years and older using the Exact Sciences Nasal Swab Home Collection Kit when home collection is determined to be appropriate by a healthcare provider, or (2) collected using the Everlywell COVID-19 & Flu Test Home Collection Kit when used consistent with its authorization. Specimens collected using the Exact Sciences Nasal Swab Home Collection Kit and Everlywell COVID-19 & Flu Test Home Collection Kit can be transported at ambient temperature for testing.

My Takeaways

I’m very impressed by Exact Science’s display of optionality and execution through COVID in 2020. The company ended FY 2019 with $876 million in revenue, up 93% from 2018. In February of 2020 (before the impact of COVID), management guided to revenue of $1.63B for FY 2020 which would have been 86% YoY growth.

Management guided for screening revenue to be $1.15B and Precision Oncology revenue