Nuclear magnetic resonance spectroscopy, primarily used to quantify and characterize lipoproteins and lipids, remains under-researched and underutilized in clinical laboratories despite its significant potential, writes Mark Kellogg, associate director of chemistry at Boston Children's Hospital. With the increasing popularity of personalized medicine, the metabolome and metabolomics in clinical diagnostics, "clinical laboratorians need to keep the capabilities of NMR in mind when looking for technology to address the questions being asked and improvements in efficiencies being demanded," writes Kellogg.
The FDA has granted breakthrough device designation to Bio-Techne's ExoDx Prostate Intelliscore test, which is designed to evaluate a man's risk of developing prostate cancer. "This assay [has the] ability to give urologists a more precise, genetically informed understanding of a man's risk for aggressive disease via a simple urine sample, without the need for an invasive prostate tissue biopsy," said Bio-Techne President and CEO Charles Kummeth.
A midstage study of sevuparin as a treatment for the management of painful vaso-occlusive crises in people with sickle cell disease found it did not result in clinically meaningful improvements. Modus Therapeutics said it will consider developing the drug for other indications.
World Blood Donor Day is being observed today to highlight the importance of saving lives through blood donation. AABB joins the World Health Organization in honoring volunteer blood donors for their generous, life-saving donations on World Blood Donor Day. This year's theme, "Safe blood for all," seeks to raise awareness about the continued need for safe blood and blood products and the crucial role that voluntary donation plays in achieving the goal of universal access to safe blood products.
Thomas Schinecker has been appointed as the new head of Roche Diagnostics, replacing Michael Heuer, who led the $13-billion-per-year business on an interim basis for several months. Roche CEO Severin Schwan noted Schinecker, who started working as a trainee for Roche Diagnostics in 2003, has "broad and international experience."
Fujifilm's FujiLAM, or SILVAMP TB LAM, a point-of-care assay using urine samples to test for tuberculosis in HIV-positive patients, was found to be superior to Abbott's AlereLAM, or Alere Determine TB LAM Ag.
The FDA has granted 510(k) clearance to Akonni Biosystems' TruDiagnosis system, which can perform multiplex analyses of clinical samples and automate complex laboratory processes. The molecular diagnostic platform can "handle any protein or nucleic acid-based assay," according to the company.
A funding round has pulled in $4.1 million for precision oncology genomics testing firm Saga Diagnostics. The Sweden-based company will use part of the proceeds to fund new product development and expedite market launch of its portfolio of kits and services.
UK firm Sphere Fluidics secured $2.9 million in the additional tranche of its funding round, bringing the total amount raised to $4.8 million. Proceeds will be used as working capital for the firm's Cyto-Mine single-cell analysis system, and to fund expansion of its UK facility and open a new sales office and demo lab in the US.
Laboratories handle calcium measurements in a variety of ways; for example, some measure ionized calcium in all samples while others measure it only in specific patients when there is a clinical indication. For other patients, those labs may report albumin-adjusted total calcium "with the caveat that--given the differences in the performance of published correction equations--each laboratory should derive its own equation for correcting total calcium based on albumin," writes Tahir Pillay, head of the department of chemical pathology at the University of Pretoria in South Africa.
- Page 1