FDA Issues its First Emergency Use Authorization for an Antigen-based Diagnostic as Top IVD Manufacturers Race to Supply Medical Laboratories with COVID-19 Tests

Though experts say an antigen test is not as accurate as PCR tests, its low cost, ease of use, and widespread availability make it a boon for clinical labs performing COVID-19 testing While COVID-19 exploded around the world, the US Food and Drug Administration (FDA) unleashed the nation’s in vitro diagnostics developers by issuing dozens of Emergency Use Authorizations for new coronavirus laboratory-developed tests (LDTs). Most of these EUAs are for Reverse Transcription-Polymerase Chain...

Top-5 Diagnostics Trends Identified by Kalorama Will Impact In Vitro Diagnostics Manufacturers, Medical Laboratories in 2017

Report states IVD companies are focusing on core lab, seeking China FDA approval, and targeting urgent care Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on in vitro diagnostics (IVD) manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service—such as urgent care centers and retail clinics—are motivating IVD companies to tailor new diagnostic...

Diagnostics Marketing Association’s (DxMA’s) Global Marketing Summit Will Convene in New Orleans Just Prior to the Executive War College (EWC) to Discuss Primary Trends Facing IVD Manufacturers, Clinical Laboratories

The DxMA Summit’s agenda will complement EWC’s and will explore disruptive technologies likely to be of great interest to medical laboratory leaders and pathology groups Cybersecurity, wearable technology, and social media are the primary trends facing in vitro diagnostics (IVD) manufacturers and clinical laboratories. That’s according to Debra Harrsch, President-elect of the Diagnostics Marketing Association (DxMA), a self-funded organization devoted to helping diagnostic marketing...

Precision Healthcare Milestone Reached as Food and Drug Administration Clears New Multi-Marker Medical Laboratory Test to Detect Antibiotic-Resistant Bacteria

FDA issues press release following clearance of a clinical lab test to detect genetic markers that indicate the presence of Carbapenem-resistant Enterobacteriaceae Clearance by the US Food and Drug Administration (FDA) of a new rapid, multi-marker genetic test designed to identify bacteria that are resistant to Carbapenem antibiotics was considered significant enough that the federal agency issued a press release announcing that the test was cleared and now available for use by physicians and...

Comparison of In Vitro Diagnostic Industry’s Top Five Trends for 2015 and 2016 Reveals Rapid Technology Advances Intended to Give Clinical Laboratories New Diagnostic Tools

Of the five trends described in a report published by Kalorama, only two made the list for both years: Consolidation within the IVD industry and growth in molecular point of care What a difference one year can make in the most significant trends influencing the in vitro diagnostics (IVD) industry, which also influences clinical laboratories, the largest customers of IVD manufacturers. These insights come from comparing the top five IVD trends for 2016 as identified by Kalorama Information from...
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