Keeping you up to date on recent developments in diagnostics, including: Preventing birth defects; Full-waveform inversion for brain imaging; From junk to noncoding to coding; An efficient strategy for Legionella detection.
San Francisco-based Invitae Corp. is putting pedal to the metal in its quest to bring comprehensive genetic testing into mainstream clinical practice, reporting the acquisition of three companies – Diploid, Youscript Inc. and Genelex Labs LLC – following Tuesday’s market close. The total bill for the three deals comes to $195 million, $57 million of which is in cash.
Novi, Mich.-based startup Delphinus Medical Technologies Inc. has been working for roughly a decade to introduce whole breast ultrasound tomography to improve breast cancer diagnosis and treatment.
U.S. FDA commissioner Stephen Hahn appeared before a congressional panel to discuss the administration’s budget proposal for the agency, but the outbreak of COVID-19 predictably dominated the proceedings.
Avellino Lab USA Inc. has developed a diagnostic test for the novel coronavirus SARS-CoV-2, which has been validated in keeping with the U.S. Food and Drug Administration (FDA)'s Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency. Physicians can order the assay now, while the company continues testing.
Despite the growing concerns about the potential for the community spread of COVID-19 in the U.S., the FDA-FTC public workshop on competition in the biologics marketplace went ahead as scheduled March 9, playing to a full house with some audience members sitting in an overflow room. And all the invited speakers and people registered to speak during the open public hearing session showed up.
LONDON – The World Health Organization (WHO) has released its COVID-19 R&D roadmap, highlighting the gaps in knowledge about the virus and setting out priorities for research. The organization is now calling on groups around the world to use the document – drawn up by 400 experts – to coordinate their efforts.
The latest version of legislation for regulatory reform has arrived, and the conventional wisdom may be that the Verifying Accurate, Leading-Edge IVCT Development (VALID) Act will not be passed until the next user fee agreement is codified into law. Nonetheless, Susan Van Meter, executive director of AdvamedDx, told BioWorld that the associated reforms are urgently needed by patients and test developers alike, and there is consequently no need to wait for user fee legislation to pass the VALID Act.
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