How labs should address conflicts between direct, indirect ISE results | Case highlights potential for false potassium results in blood test | FDA clears inui Health's smartphone device for urine testing
There are a variety of pitfalls in using indirect ion-selective electrode values and the level of proteins, albumin or triacylglycerols to calculate sodium concentration in patients with hyperproteinemia or hyperlipidemia. Beyond certain protein and lipid concentration cutoffs, labs should report serum electrolyte levels through direct ISE only, according to this piece, and they should talk to clinicians about the potential for discrepancies between these two technologies.
A 55-year-old woman with chronic lymphocytic leukemia underwent dialysis based on what turned out to be a false positive for high potassium levels, likely due to the use of a sample that had been centrifuged, according to a case study in the journal Laboratory Medicine. The case illustrates the need to be aware of the potential for a false potassium level for patients with high white blood cell counts, researchers said.
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Inui Health has secured clearance from the FDA to market its smartphone system for urine testing for detection of diabetes, urinary tract infection, kidney problems, pregestational diabetes and preeclampsia.
The FDA has issued final guidance on its process for benefit-risk considerations on new 510(k) products whose technological characteristics differ from their predicate devices. The agency will hold a webinar Nov. 1 to talk about the guidance and answer questions on the document.
Roche Holding will begin marketing FoundationOne Liquid, a blood test from Foundation Medicine that can analyze the presence of 70 common gene mutations in a patient's blood sample from circulating tumor DNA that comes from solid tumors. The new assay also has features that can pinpoint which patients have a higher chance of benefiting from cancer immunotherapy.
A round of financing involving Ping An Global Voyager Fund and other investors has pulled in more than $70 million for Haifa, Israel-based diagnostics firm MeMed.
The company will use the funds to complete development and clearance and upscale manufacturing for its point-of-care protein-measurement platform MeMed Key; expand market adoption of MeMed BV, an immune system-based test for viral and bacterial infection differentiation; and increase its pipeline of innovative tests that use immune-based measurements and machine learning technology.
The NIH awarded Kephera Diagnostics a two-year, $599,316 Phase I Small Business Innovation Research grant to go toward work on a point-of-care test to diagnose Chagas disease. The company said it has developed a prototype assay with higher analytical sensitivity than Chagas tests currently on the market.
Atomo Diagnostics and Mylan Pharmaceuticals have signed a global marketing agreement to commercialize the former's CE-marked HIV self-tests in over 100 nations in Asia, Africa, Latin America, the Middle East and the former Soviet Union. A global launch for the Mylan HIV Self-Test is slated for early next year.
There's less than one week left to submit your application. Apply today to stand out as a point-of-care testing professional that has gone above and beyond to demonstrate proficiency in one of the fasting growing disciplines within laboratory medicine. Deadline to submit: Sept. 30, 2018 5PM ET.