FDA Grants CLIA Waiver Allowing First Test for Chlamydia and Gonorrhea to Be Performed at the Point of Care

Federal regulators continue to recognize value of clinical laboratory testing in near-patient settings To help in the diagnosis and management of two sexually-transmitted diseases, another point-of-care diagnostic test will soon be available for use in physician’s offices, urgent care clinics, and other healthcare settings. The federal Food and Drug Administration (FDA) announced it granted a CLIA waiver for the binx health io CT/NG assay, a molecular platform used to detect sexually...

Forbes Tells the World How Medicare Bollixed Molecular Diagnostic Test Payments, Leaving Nation’s Clinical Laboratories Unpaid for Months

Columnist Steve Gottlieb, M.D., wrote that “This sort of bungling may be without precedent, even for the Medicare agency” Since the beginning of the year, most Medicare contractors and private health insurers have not paid clinical laboratories and anatomic pathology practices for molecular diagnostic test claims coded to the 114 new molecular test CPT codes. This unprecedented situation of labs going unpaid for more than three months has created financial turmoil and uncertainty across the...

Big News in Clinical Laboratory Informatics as Roper Industries Agrees to Pay $1.4 Billion to Acquire Sunquest

Medical labs and pathology groups using Sunquest LIS products likely to see positive changes from Sunquest’s fourth change in ownership since 2001 In what is likely to be the biggest deal in clinical laboratory and pathology informatics for this year, Roper Industries, Inc. (NYSE: ROP), of Sarasota, Florida, will acquire Sunquest Information Systems, Inc., of Tucson, Arizona. The purchase price is an impressive $1.42 billion dollars and the deal was announced on Monday this week. Roper...

All-Stars in Pathology Informatics and Clinical Laboratory Information Systems Gather in Pittsburgh to Assess Market Changes

Pathology profession’s leading experts in lab informatics predict plenty of disruption as hospitals work to integrate their informatics systems DATELINE—PITTSBURGH, PENNSYLVANIA: Last Friday, what I will call the All-Stars of pathology informatics and clinical laboratory information systems (LIS) came together for a one-day Strategy Summit. Disruptive forces are loose within the laboratory informatics space and participants were eager to understand these trends and develop effective responses...

Leapfrog Study Shows Hospital Use of CPOE Can Affect Clinical Pathology Laboratory Test Utilization

Study Finds Weaknesses in the Performance Of CPOE System in Daily Care Settings Many experts believe that wider use of computerized physician order entry (CPOE) systems can contribute to the better utilization of clinical pathology laboratory tests. CPOE is considered one method for helping the physician order the right medical laboratory test for the patient at the right time—then use the clinical lab test results to implement the most appropriate therapy. CPOE is an important...
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