Diagnostics

FDA: The steps we’re taking to push precision medicine forward

"At FDA, we're thinking very seriously about genomics," Litwack said. "Genetic tests and in vitro diagnostics are driving a lot of the advancements in medical science today."

Standardizing the quality of diagnostics that use next-generation sequencing is a huge priority of the Food and Drug Administration as it moves to promote the adoption of precision medicine.

“We want this because precision medicine is moving so quickly,” said David Litwack, a staffer in the FDA’s precision medicine unit, during a presentation at Mayo Clinic’s Individualizing Medicine conference this week. “We want to build a dynamic system that we don’t have to update every time there’s a change – and that accounts for the rapid changes in this field.”

Here are some interesting slides from Litwack’s presentation at the Mayo Clinic conference, that really outline the FDA’s approach to precision medicine:

FDA announced last month that it’s launching an open-source platform called precisionFDA that allows community sharing of genomic information. It’s one of the latest developments of the White House’s Precision Medicine Initiative – and it’ll launch beta testing of the cloud platform this December.

“Our new regulatory strategies involve developing and implementing standards for quality,” Litwack said. This involves standards for the analytical performance of NGS tests, ensuring they meet some minimum bar of quality.

Here’s the outlines of how it works:

 

FDA has had a fairly long history in helping push precision medicine forward. As Litwack pointed out, FDA has approved 23 companion diagnostics. It has helped validate 40 biomarkers that are used in targeting 147 approved drugs, in conditions like cystic fibrosis, cancer, cholesterol, pulmonary disease, psychiatric disorders and infectious disease.

“At FDA, we’re thinking very seriously about genomics,” Litwack said. “Genetic tests and in vitro diagnostics are driving a lot of the advancements in medical science today.”

But, simply put, traditional clinical studies are often not possible because the number of patients with a given variant is usually too small. It’s hard for the FDA to work lithely to approve tools that are rapidly developing in this nascent field – which is why it’s launching tools like precisionFDA.

 

The message the agency’s trying to convey? Despite being regulators, it has the same end goals as academicians and industry: Get this precision medicine thing going.

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