FDA moves to electronic-only device submissions
December 13, 2019 -- The U.S. Food and Drug Administration (FDA) now requires medical device premarket submissions to be sent electronically, eliminating the need for multiple paper submissions.
Senate confirms Hahn as FDA commissioner
December 13, 2019 -- The U.S. Senate has confirmed the Trump administration's nomination of radiation oncologist Dr. Stephen Hahn as commissioner of the U.S. Food and Drug Administration (FDA).
CAP deems surprise billing deal 'unacceptable'
December 11, 2019 -- The just-announced legislative proposal to use benchmark payment rates based on median or mean in-network contracts for out-of-network physician billing -- or so-called surprise billing -- is "unacceptable," the College of American Pathologists (CAP) said in a statement.
Celmatix takes ex-partner 23andMe to court over soured 'femtech' deal
December 11, 2019 -- Celmatix has filed a lawsuit seeking damages in excess of $100 million from ex-research partner 23andMe related to the breach of an agreement centered on reproductive and fertility testing services.
Invitae launches free tests for skeletal dysplasia
December 10, 2019 -- Invitae is offering free testing in the U.S. to detect genes associated with skeletal dysplasia in symptomatic pediatric patients through a new program funded by biopharmaceutical company BioMarin, which develops and markets drugs for rare hereditary diseases.
NeuMoDx and Sentinel partner on PCR assays
December 10, 2019 -- NeuMoDx Molecular and Sentinel Diagnostics are developing multiple new real-time polymerase chain reaction (PCR) assays for use on the NeuMoDx 96 and 288 models of molecular systems through a new collaboration.
C2N offers strong proof-of-concept data for Alzheimer's blood test
December 9, 2019 -- C2N Diagnostics reported positive results for its APTUS-Aβ blood test for beta-amyloid (Aβ) isoforms 42 and 40 for early Alzheimer's pathology in a multicenter U.S. proof-of-concept study of 415 samples taken from six different locations.
VA endorses AI research with new institute
December 9, 2019 -- The U.S. Department of Veterans Affairs (VA) has set up a new institute, the National Artificial Intelligence Institute, dedicated to advancing artificial intelligence (AI) research that might be meaningful to veterans and the public.
AbbVie to deploy Adaptive's clonoSeq test in myeloma trials
December 9, 2019 -- AbbVie is set to use Adaptive Biotechnologies' clonoSeq next-generation sequencing test for measuring minimal residual disease as a marker of treatment response across its trials of the B-cell lymphoma 2 inhibiting drug venetoclax (Venclexta) in multiple myeloma.
Modern Pathology names Netto as new editor
December 6, 2019 -- Dr. George Netto of the University of Alabama at Birmingham has been named the new editor in chief of Modern Pathology, effective January 1, 2020.