Diagnostic Testing and Emerging Technologies
LAB COMPLIANCE ADVISOR
LABORATORY INDUSTRY REPORT
NATIONAL LAB REPORTER
In early November 2019, the U.S. Food and Drug Administration (FDA) updated a previous safety communication about the potential of biotin to significantly interfere with diagnostic tests. The update reiterates the warning
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Facebook founder Mark Zuckerberg grabbed headlines this week because of the letter he and his wife wrote to their newborn daughter announcing they will give 99 percent of their Facebook shares...
By Ron Shinkman, Editor, Laboratory Industry Report Struggling Transgenomic has exited the genetic assay business. The Omaha, Neb.-based company announced this week it had sold its genetic assays and platform unit to ADSTEC Corp., a Japanese company. The sales...
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Cigna became the first national health insurance plan to publish a coverage policy on whole exome sequencing (WES). The insurer defined coverage criteria for WES, but still will not cover WGS for...
By Kelly A. Briganti, Editorial Director, G2 Intelligence The OIG's FY 2015 Top Management and Performance Challenges target clinical laboratories among other providers as a necessary focus of efforts to fight fraud, abuse and waste in Medicare. Specifically, the...
By Ron Shinkman, Editor, Laboratory Industry Report California-based Avellino Labs has expanded its molecular testing menu for patients who are considering lasik or other elective surgeries that will alter the structure of their eyes. Elective laser eye surgery,...
From - Diagnostic Testing & Emerging Technologies
Early in the year DTET spoke to experts that predicted 2015 would be the year that liquid biopsy technology penetrates the clinical oncology market. These predictions did not disappoint. A near continuous stream of publications, conference presentations, and…
By Kelly A. Briganti, Editorial Director, G2 Intelligence This past year brought many unwelcome reimbursement developments—most notably, the initial steps to implement PAMA; but it also included the repeal of the dreaded Sustainable Growth Rate. The Centers for...
By Kelly A. Briganti, Editorial Director, G2 Intelligence The OIG released its Semiannual Report to Congress detailing its program integrity and oversight activities for the second half of the 2015 fiscal year (April to September) and highlighting its...
By Kelly A. Briganti, Editorial Director, G2 Intelligence Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug Administration...