Lab News
Antiopioid law could criminalize sales commissions for clinical lab patient referrals
April 18, 2019 -- A federal law passed to combat the opioid crisis could have unintended consequences by criminalizing sales commissions paid by clinical laboratories to their salaried sales representatives for patient referrals. Under the statute, such payments could be considered kickbacks for referrals. Read More
Quest sells STD tests directly to consumers
April 18, 2019 -- Quest Diagnostics has launched new test packages for sexually transmitted diseases (STDs) that will be sold directly to consumers as part of its QuestDirect program. Read More
Beckman Coulter gets FDA nod for early sepsis test
April 18, 2019 -- Beckman Coulter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Early Sepsis Indicator, a hematology-based cellular biomarker designed to assist emergency department physicians with the triage and diagnosis of sepsis. Read More
Hologic's ThinPrep Genesis slide processor gets CE Mark
April 18, 2019 -- Hologic has received the CE Mark for its ThinPrep Genesis processor for cytology slide and molecular test preparation, giving the company the go-ahead to market the system in Europe. Read More
Open-access software takes aim at ELISA test variability
April 18, 2019 -- Researchers from Boston have developed open-source software called ELISAtools that is designed to reduce the variability in enzyme-linked immunosorbent assay (ELISA) tests used for research. They describe their work in an April 17 article in PLOS One. Read More
USPSTF questions blood lead screening in children, pregnant women
April 17, 2019 -- Blood testing for elevated lead levels is accurate, but there is not enough evidence to support the screening of asymptomatic pregnant women or asymptomatic children 5 years of age or younger, the U.S. Preventive Services Task Force (USPSTF) has concluded in a final recommendation statement. Read More
Genomics England passes 1st liquid biopsy testing phase with industry partners
April 17, 2019 -- Government-backed Genomics England has passed the first phase of testing with partners Inivata and Thermo Fisher Scientific in evaluating the use of liquid biopsies for cancer diagnosis. Read More
CAP, ASCO taking comments on guidelines for breast cancer receptor testing
April 16, 2019 -- The College of American Pathologists (CAP) and the American Society of Clinical Oncology (ASCO) are taking comments on a proposed revision of guidelines covering immunohistochemical testing for estrogen and progesterone receptors in breast cancer. Read More
Ortho gets CE Mark for Vitros troponin I assay
April 16, 2019 -- Ortho Clinical Diagnostics has received the CE Mark for Vitros, the company's high-sensitivity troponin I assay for detecting signs of heart attack. Read More
Labs gear up to diagnose novel fungal infection
April 15, 2019 -- Clinical laboratories are being advised by the U.S. Centers for Disease Control and Prevention on how to handle a relatively new fungal infection, Candida auris, that is detectable only with complex tests such as mass spectrometry, sequencing, and novel polymerase chain reaction assays. Read More
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