Health Sciences Innovation

Objectively Assessing an In Vitro Diagnostic Startup

Objectively Assessing an In Vitro Diagnostic Startup Analyze

Confirming a startup's product development plan and timeline

An in vitro diagnostic (IVD) startup was seeking funding for an advanced test for respiratory illness that could significantly improve critical care and emergency room triage. Potential investors, wanting to know if the science and business plans were sound, turned to Exponent for a thorough evaluation.

The Challenge

When patients arrive at the emergency room with respiratory distress, it could be caused by COVID-19, influenza, pneumonia, or more than a dozen other things. The correct diagnosis is vital for determining whether to use antibiotics or newer antiviral medications. And until doctors know for sure it's not COVID-19 or another highly communicable disease, the patient must be kept in valuable isolation space. An IVD startup was promising its new test could find the answer across over 20 possible pathogens within 30 minutes, 50% faster than the incumbent in the marketplace.

But the road from a promising technology to a viable product is complex. Our client wanted to acquire the startup company, with many questions remaining about its science, product development plan, and the business itself. Did the technology work? Could the product be developed in the proposed timeframe?  Were the clinical trial plan and regulatory strategy sound? What were the development, scale-up, and regulatory risks?

To address each question with the right multidisciplinary perspective, Exponent brought together a dynamic team of Biomedical & Engineering Sciences, Mechanical Engineering, Polymer Science & Materials Chemistry, and Electrical Engineering & Computer Sciences experts who worked together seamlessly. 

EXPONENT's Multidisciplinary Solution

Exponent studied multiple aspects of the product and business, employing experts in molecular diagnostics, manufacturing, and clinical studies along the way. Our team delivered a comprehensive assessment to help inform the client's investment decisions.

Exponent's Impact 

 Our team determined that the startup's science and product were sound, aside from some fixable design issues. The startup's timetable for getting to market, however, was overly ambitious. With an additional six months needed for product development and a year more expected for clinical trials, Exponent provided the client with the hard facts and science-based risks regarding their potential investment.