What labs should know before selecting a lipoprotein(a) assay | Liquid biopsies considered for assessing cancer treatment resistance | Universal screening for HCV beneficial for at-risk pregnant women
Laboratories adopting immunoassays for lipoprotein(a), which are designed to identify individuals at increased risk of cardiovascular disease, should determine providers' expectations on the targeted patient population and on guidelines for Lp(a) levels. Labs and clinicians should be aware of racial/ethnic differences in Lp(a) levels, particularly in African-Americans.
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Dr. Joshua Bauml said liquid biopsies have the potential to be an alternative to tissue biopsies in assessing resistance to cancer treatments. "We draw blood and request urine samples from our patients all the time, and the ability to test this serially is very appealing when we consider the fact that resistance develops over time," Bauml said at the 36th Annual Chemotherapy Foundation Symposium.
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Interpace Diagnostics has scored a reimbursement win from the Blue Cross Blue Shield federal program for its ThyGeNEXT and ThyraMIR thyroid cancer tests.
An innovation challenge launched by the FDA to address the opioid crisis through device-based treatments, mobile apps and diagnostic tests has received more than 200 applications from companies, including Stimwave, Abbott and SPR Therapeutics, hoping to see faster approval for their technologies.
The FDA is pleased by "the acknowledgment from developers about the unique and important role medical devices, including digital health technologies like mobile medical apps, have the potential to play in tackling the opioid crisis," FDA Commissioner Scott Gottlieb said.
Device industry group AdvaMed is working on a major push to get the medical device tax repeal passed during the lame-duck session, says Greg Crist, head of government affairs and interim chief advocacy officer at AdvaMed. "There may not be a better shot in a long while to get repeal than in these final few weeks," Crist says.
The FDA has approved Ortho Clinical Diagnostics' VITROS HIV Combo test, or VITROS Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator, to be used with the VITROS 5600 Integrated System.
Chembio Diagnostic Systems' DPP Ebola Antigen System is the second rapid antigen fingerstick test granted emergency use authorization by the FDA to detect the Ebola virus in patients. It is the first that uses a mobile battery-operated reader, which allows it to provide diagnostic results outside of laboratories.
A Series A financing round has pulled in about $3.7 million for Canada-based medical technology firm Rna Diagnostics. Part of the proceeds will be used to commercialize the company's RNA disruption assay.
November 28, 2018 Join Dr. Judith Monroe as she explains how to ensure your lab is practicing the latest guidelines for testing and diagnosing infectious diseases in pregnant women.
