Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, today announced the launch of the Cancerguard™ test, a new multi-cancer early detection (MCED) blood test that is now available as a laboratory-developed test (LDT) in the United States. Cancerguard is the first MCED test commercially available that analyzes multiple biomarker classes to help detect a wide range of cancers, including those that often go undiagnosed until later stages when treatment options are limited.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced it has reached a strategic agreement with LabFlorida/SunDx Labs to provide residents of senior living communities access to Guardant Shield™, the first blood test approved by the U.S. Food and Drug Administration (FDA) as a primary screening option for colorectal cancer (CRC). As part of the agreement, LabFlorida will serve as the exclusive distributor to senior living communities throughout Florida. LabFlorida/SunDX provides premier concierge-style lab testing, tailored specifically for assisted and independent living and homebound patients.
Different medical institutions have selected different imported and domestic brand instruments: 38 domestic and 58 imported.
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced a strategic partnership with PathGroup, one of the nation’s leading partners to physicians, hospitals, and healthcare networks nationwide, to significantly expand the reach of Guardant’s FDA-approved Shield™ blood test. The partnership will bring Shield to more than 250 hospitals and health systems, over 15,000 PathGroup-affiliated physicians across 25 states, and allow more patients to benefit from Guardant’s industry-leading Shield blood test for early cancer detection through PathGroup’s large network of EMR hospital integrations and phlebotomists. More than five million patients each year receive testing through PathGroup.
Coagulation analyzers are mainly applied for laboratory tests of thrombosis and hemostasis, which can provide valuable indicators for the diagnosis and differential diagnosis of hemorrhagic and thrombotic diseases, detection, and efficacy of thrombolytic and anticoagulant therapy.
As indicated by the release of the China Cardiovascular Health and Disease Report 2019, the current number of cardiovascular patients is 330 million and is still on the rise.
Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® HCV VL Fingerstick, an HCV RNA test that detects and quantifies HCV directly from a drop of blood, simplifying the diagnostic pathways to speed up linkage to care and monitoring sustained virological response. Xpert HCV VL Fingerstick test is performed on the GeneXpert® system.
Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today the availability of the Lumipulse® pTau-217/Beta Amyloid 42 Ratio, the first blood-based in-vitro diagnostic (IVD) test cleared by the U.S. Food and Drug Administration (FDA) to aid in the diagnosis of Alzheimer's disease through early detection of the amyloid plaques associated with the disease in appropriate patients. Developed by Fujirebio Diagnostics, Inc., the test is now available nationwide through Labcorp.
The boundaries between the POCT and laboratory-based systems for blood and electrolyte testing are somewhat blurred, and instruments can be used in multiple scenarios.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today it has received CE Mark for its Elecsys® pTau181 test to measure phosphorylated Tau (pTau) 181 protein which is an indicator of amyloid pathology, a hallmark of Alzheimer’s disease. The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out Alzheimer’s disease as the cause of cognitive decline. This could avoid the need for further confirmatory investigation for patients testing negative.
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