diagnostic testing

Why have diagnostic tests for the Coronavirus been slow on the scene? What have been the challenges for lab directors? Were they scientific? Were they regulatory? Were they scaling challenges? Are they still scaling challenges? Supply chain problems?

Elaine Lyon worked for many years at the molecular genetics lab at ARUP at the University of Utah and is now the Clinical Services Lab Director at Hudson Alpha. In both of these jobs she has designed and overseen the design of many diagnostic tests.

She takes us behind the scenes and talks about the many challenges so many lab directors have been facing over the past month in developing good diagnostic tests for the Coronavirus. Perhaps she will answer some of your questions.

“It got to us before we had many papers to be looking at. We’ve been doing it so quickly. Usually in the scientific field, you do appropriate experiments, you analyze, you draw your conclusions, write up your findings, submit for publications, which is then peer reviewed and published and disseminated to the scientific community. Obviously that wasn’t able to happen here. So we’ve been communicating in other ways. Still going to what is published online. And yet we need to make sure this information is correct."

After the virus reached American shores, was the FDA quick enough to allow companies and labs to develop their own tests without restrictive oversight? The question sparked a sweeping new bill in congress, the VALID Act that could overhaul FDA oversight of diagnostics altogether—something that has been clamored for for a generation.

Turna Ray has been covering the FDA and diagnostics for GenomeWeb since 2006. She has recently written a piece on the new VALID Act that includes responses from various members of the community.

As Turna says in her piece, now could be an odd time for Congress to be putting through such important legislation regarding FDA’s oversight of diagnostics and LDTs with everyone in crisis mode. It could be an appropriate time as well. As one community member told Turna:

“Historically it often takes a big public health catastrophe to change the regulatory system for medical products."

What is the general state of testing today? Why was the CDC so slow? Will at-home tests happen? Turna covers all of this in her interview.

Laura comes to us from her flat in New York, Nathan is stuck in San Diego, but they are here and ready to discuss what a month ago was a warning and now is a full blown world crisis. What have they faced personally? What are their thoughts on testing? And what are some of their early big picture reactions as to how this will all go down?

We make some time for some Corona-free science as well.