Tempus AI Shares Up After FDA Clearance for In Vitro Diagnostic Device

By Freddy Sebastian

Tempus AI Inc. shares rose after it said it received 510(k) clearance from the Food and Drug Administration for its RNA-based in vitro diagnostic device.

Its stock recently rose 5.2% to $92.85 in morning trading.

RNA sequencing captures a large array of biological information and offers deeper insights into the mechanisms of diseases, including enhanced fusion detection, the healthcare technology company said Monday. RNA analysis is increasingly an important tool in research and development because it can identify molecular pathways and networks that are directly involved in disease progression.

"We have long known that RNA sequencing offers additional insights beyond DNA alone, but only now are we beginning to unlock its full value in supporting therapeutic development," said Kate Sasser, chief scientific officer. "This FDA clearance further demonstrates the promise of RNA sequencing and opens up new opportunities for us with our biopharma customers."

The company said its life science partners would be able to leverage its RNA assay to more precisely identify which patients would be most likely to respond to specific therapies and will be able to design more efficient clinical trials.

Write to Freddy Sebastian at freddy.sebastian@wsj.com