Adam Bonislawski

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

Investment firm Kent Lake said the securities deal, which is linked to the firm's planned acquisition of Akoya, is "backdoor financing" and "highly unfavorable to Quanterix shareholders."

The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.

Stakeholders expressed hope that the Trump administration's funding disruptions are temporary but noted academia's key role in generating investment opportunities.

Public health labs have handled most testing thus far for the Texas and New Mexico outbreaks, but commercial labs are beginning to bring molecular measles assays online.

The company said it expects its first quarter revenue to be down 10 percent to 15 percent year over year due in part to a decline in US academic sales.

The deal is part of BioReference's ongoing effort to streamline its business to achieve profitability and follows the sale last year of clinical laboratory assets to Labcorp.

Such tests are increasingly moving beyond their origins in cutting-edge research and into the laboratory and diagnostic mainstream.

While electronic exchange of orders and results is commonplace in the commercial lab world, public health labs struggle with inconsistent levels of connectivity.

Following pushback from industry stakeholders, the Trump administration appears to have reversed a number of the planned CDRH layoffs.