Former FDA chief Scott Gottlieb’s favorite real-world evidence platform is getting a new stream of cash, as it nears what will likely be the biggest test of the young company so far.

Aetion, the New York health tech startup, has for the second time raised an extension to their Series B, adding $19 million from J&J’s VC arm, Greenspring Associates and EDBI to bring their round to $82 million. Gottlieb, who championed real-world evidence as commissioner and later joined the company’s board, said in a statement that the new cash would help fuel a global expansion.

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.

Traditionally, the healthcare industry has moved slowly when embracing new technology innovations.

However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received increased attention is real-world data (RWD), specifically, the ways in which RWD can be used in clinical research to quickly reveal insights about treatments, outcomes, and risk factors for COVID-19.

The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

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At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic.

The FDA will be working to provide industry what data it believes is needed “to make that first assessment of patient safety, according to Hahn.

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FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform population testing strategies and help understand how widespread the virus is.

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FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.

Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used PCR-based diagnostics and serological antibody tests.

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a potentially lasting and positive impact on the agency’s view of the utility of RWE to support – or even guide – drug approvals and labeling expansions beyond the context of the current public health emergency.