Helping transform medical discovery and innovation into viable solutions that can impact the world

The demand for rapid, accessible COVID-19 testing has driven more than a thousand companies to develop over 1800 diagnostic tests. Which solutions will meet commercial success depends on many factors including technology, use case, scalability, and of course cost. One or two years from now, which companies will stand strong, while their would-be competitors regroup or fail? Following his talk, one-on-one sessions are available with Mickey. Register here: https://qb3.org/upcoming-events/2020/10/1/qb3-seminar-mickey-urdea-halteres-associates

Dr. Mickey Urdea and Mr. Rich Thayer of Halteres Associates are authors on a recently published BMJ Innovations article entitled "Post-Mortems on Diagnostic Testing Start-ups: Reports of Commercial Successes and Failures and the Case of the Zombie Life Science Company." This article provides an in depth exploration of 28 diagnostics companies that were categorized as successful, failed, or zombies (companies have achieved financial solvency but without long-term viability). A five-phase framework was developed to generate a score that could predict diagnostic companies more likely to successfully and sustainably enter the market from those more likely to fail. https://innovations.bmj.com/content/early/2020/09/16/bmjinnov-2020-000431

Click here to access the SARS-CoV-2 Use Cases White Paper

Dr. Mickey S. Urdea is an invited speaker at the Cambridge Healthtech Institute's (CHI) breakOut free webinar series, "Testing for COVID-19 and Beyond". The CHI breakOut webinars are focused on connecting the life science community to advance COVID-19 diagnostics and therapeutics. Register at this link: https://www.covid-19webinars.com/covid-19-testing

Primum Non Nocere: Is the Performance of Available SARS-CoV-2 RNA and Immunoassays Good Enough To Do No Harm? 

» COVID-19 Diagnostic Use Cases

» Halteres SARS-CoV-2 Use Case Tables

March 26, 2020

Hello Readers:

We appreciate the overwhelming positive responses from so many of you concerning the COVID-19 test Use Case discussion we posted in our Newsletter of Friday March 20, 2020. We also are grateful for the inputs we have received. We will make modifications and improvements over time.

As promised, we have posted the COVID-19 Use Case Tables on our website. There are more details now for the six Use Cases presented than we presented last week. In addition, we provide three new Use Cases:

Use Case 7: Previous SARS-CoV-2 Exposure
Use Case 8: Surveillance in Sites of Previous or Potential Outbreaks
Use Case 9: Environmental Monitoring

These are quite different from the first six. In addition, we are accumulating additional Use Cases from a number of sources that we will address subsequently.

We greatly appreciate the inputs we received from Ranga Sampath and his team at FIND concerning the new Tables. They made a series of suggestions that we have tried to address.

As has been attributed to everyone from Cicero to Oscar Wilde, "If we had more time, it would have been shorter." Nevertheless, it is our hope that those of you involved in the development of SARS-CoV-2 tests will find these documents useful. There's so much to consider to get to the right test for the intended use. Hopefully, this will improve your chances of success. Let us know how we can help.

Stay well,
Mickey and Rich

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