Dear LabPulse reader,
This week, U.S. regulatory agency business topped our most-read articles. A guest post from regulatory attorney Christine Bump of Penn Avenue Law and Policy explained how in vitro diagnostic (IVD) medical device reclassifications will impact IVD manufacturers. Bump answers several questions for lab leaders, including what happens when a manufacturer seeks to market an assay that has been reclassified.
Regulatory news dominated the chatterbox this week from many directions. President Donald Trump announced a blackout on federal agency communications, including divisions of the U.S. Department of Health and Human Services. That might include your contacts at the U.S. Food and Drug Administration (FDA), the U.S. Centers for Medicare and Medicaid Services, and the U.S. Centers for Disease Control and Prevention. McDonald Hopkins issued a legal update on the matter.
Otherwise, rapid molecular testing piqued the interest of the LabPulse community. Inflammatix announced that it landed marketing authorization for its rapid sepsis test system and point-of-care molecular test. The test is designed to sideline traditional blood culture and combines bacterial-viral infection scoring with a severity risk evaluation. The total amount of private capital raised by the company stands at about $200 million.
On the emerging technology front, IntelliGenome received a breakthrough device designation from the FDA for its CRISPR-Tuberculosis Blood Test. The test is the first qualitative real-time polymerase chain reaction assay to combine CRISPR technology. IntelliGenome plans to accelerate its multicenter clinical study at sites in the U.S., Mexico, and Germany this year.
Meanwhile, an Iowa pathologist told LabPulse that she has appealed a federal judge's decision to dismiss her pathology practice's lawsuit against competing pathology groups.
Thanks for reading.