Hematology thrives with decentralized approaches
November 21, 2019 -- Hematology will remain the second-largest volume of global IVD procedures, with the number of tests increasing 5.3% per year to nearly 6.7 billion in 2024, according to Bruce Carlson, publisher of Kalorama Information, who charts the rise of hematology tests.  Discuss
Ortho Sera extended blood typing clears FDA
October 18, 2019 -- Ortho Clinical Diagnostics has announced the U.S. Food and Drug Administration (FDA) clearance of its Ortho Sera ID-Micro Typing System (MTS) extended antigen phenotyping in blood transfusion products, for use on the company's Ortho Vision analyzer.
Blood centers claim FDA safety rules threaten patient access
October 4, 2019 -- The U.S. Food and Drug Administration (FDA) should continue to assess the effects of new guidance for controlling the risk of bacterial contamination of platelets in blood collection establishments and transfusion services, according to America's Blood Centers, a large network of community-based, independent blood programs in North America.
Cepheid's leukemia diagnostic receives 510(k) clearance
October 2, 2019 -- Cepheid's Xpert BCR-ABL Ultra IVD test has received clearance from the U.S. Food and Drug Administration for use in monitoring disease burden in patients with chronic myeloid leukemia.
Sysmex, LabCorp extend hematology automation pact
September 26, 2019 -- Sysmex America and LabCorp announced they are extending their hematology automation agreement. Sysmex America is providing LabCorp Diagnostics' primary reference laboratories with Sysmex's upgraded XN series technology.
Adaptive partners with Illumina for IVD test kits
September 24, 2019 -- Adaptive Biotechnologies is partnering with Illumina to bring to market IVD test kits for Adaptive's current and future portfolio of immunodiagnostics based on next-generation sequencing.
FDA approves Roche's cobas babesiosis test for blood donations
September 20, 2019 -- Roche's cobas Babesia test for screening whole blood specimens from blood donors is now approved by the U.S. Food and Drug Administration (FDA).
Amgen enlists Adaptive's clonoSeq in broad blood cancer deal
September 19, 2019 -- Adaptive Biotechnologies' clonoSeq next-generation sequencing test for minimal residual disease will be used as the preferred test for Amgen's marketed and investigational drugs for blood cancers through a new four-year global agreement.
Sysmex drives Clinical Lab 2.0 anemia project
September 16, 2019 -- Sysmex America is providing a grant to the Clinical Lab 2.0 value-based laboratory initiative to support a multi-institutional demonstration project related to the early detection, intervention, and prevention of anemia.
Instrumentation Laboratory gets POC group purchasing deal
September 5, 2019 -- Instrumentation Laboratory is set to provide point-of-care (POC) acute care diagnostics for coagulation and blood management at discounted prices to members of group purchasing organization Premier through a new contract.