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Maximizing Value

Understanding market needs. Learn More »»

Portfolio Planning

Balancing technical difficulty of development with commercial attractiveness. Learn More »»

Informatics in Molecular Medicine

The use of multi-methodology algorithms in medical practice today. Learn More »»

The Role of Impact Modeling

Establishing the “value” in high-value diagnostics. Learn More »»

Delivering Diagnostics for Global Health

Understanding needs and developing diagnostic solutions that improve linkage to care in low resource settings. Learn More »»

Point of Care Testing

Renewed interest in decentralized or Point of Care Testing: what’s changed?. Learn More »»

Consumer Digital and Mobile Health

Understanding regulatory, payment and education challenges in the consumer digital health space. Learn More »»

Latest News

Dr. Mickey S. Urdea and Mr. Rich Thayer will be presenting at the Pandemic Influenza Preparedness (PIP) Framework for the
Sharing influenza viruses & access to vaccines and other benefits — Briefing Session for AdvaMedDX Influenza Diagnostic Manufacturers, on April 13, 2021.


The Halteres Associates video production team has wrapped another video production project! Many clients have asked what exactly goes into a day on set, so here is a peek behind the scenes!   learn more

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

» 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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