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near-patient testing

Truvian Sciences Raises $105M for Near-Patient Lab Test System

DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu…

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NEWSMAKER INTERVIEW: Ralph Taylor, CEO of Sysmex America

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures. Core laboratories have something unique and irreplacea…

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Newsmaker Interview: Healthcare’s Transformation Now Bringing Changes to Lab Industry

“Today, patients want to get diagnosis and treatment faster with fewer visits to the doctor’s office. They want speedier and more comprehensive delivery of clinical services, be it laboratory tests, imaging, or other procedures.” …

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FDA CLEARS WAIVED CBC FOR NEAR-PATIENT TESTING

CEO SUMMARY: Market clearance of the first-ever CLIA waived analyzer for complete blood count and three-part differential tests could cut time-to-answer from days to mere minutes for one of the top 20 tests by volume performed at core laboratories. Developer …

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Docs’ In-Office Testing Showing Mixed Trends

CEO SUMMARY: Despite the burdens of CLIA certification and reduced reimbursement for lab tests, many medical practice experts are advising doctors to expand in-office testing. However, diagnostic technologies for near-patient testing are still not robust enough to support this trend. Earl…

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Nurse Shortage Parallels That of Fewer Med Techs

CEO SUMMARY: It’s a story that will soon become a national headline. Even as laboratories struggle to find enough med techs to fill open positions, hospitals are facing an even bigger problem in getting enough nurses to keep units staffed and open. Recruiting nurses overseas is one solu…

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Management Execution Makes a Difference

THERE’S PLENTY OF HOOROAR AND EXCITEMENT about skyrocketing stock prices for several public lab and pathology companies in 2000! But this crusty old curmudgeon has been around the investment industry too long to accept Wall Street’s new-found enthusiasm for clinical laboratories as definitive pr…

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Qualigen’s POL PSA Test Cleared for Sale by FDA

CEO SUMMARY: Qualigen, Inc. gained FDA approval to sell its FastPack™ System for PSA testing in the United States. Qualigen is one more example of a technology company that expects to shift diagnostic testing out of core laboratories and closer to the patient. Initially Qualigen will se…

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“State of Lab Industry” Reveals Radical Change

CEO SUMMARY: Pick your trend: declining reimbursement, consolidation, clinical integration, downsizing, and capitated reimbursement. These trends all continued to shape the way laboratories organized to provide services. But 1997’s wildcard was the federal government. Between investigat…

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Joint Venture In Phoenix To Be Copied Elsewhere

CEO SUMMARY: Look for the Quest-Sonora joint venture to be followed by others in coming months. Competition and marketplace realities are forcing the three national laboratories to respond with groundbreaking strategies. Hospital laboratory partners in these deals can reap significant ben…

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