Research & Development
Hematology: Page 6
Blood centers claim FDA safety rules threaten patient access
A final guidance document on blood products was issued in September. It offers recommendations for controlling risk for stored platelets intended for transfusion, including testing methods with culture-based or rapid detection devices for bacterial contamination and ensuring that procedures are in place to track the testing status of platelet products.
October 3, 2019
Cepheid's leukemia diagnostic receives 510(k) clearance
The test delivers accurate molecular results from whole blood samples in less than three hours, according to the company.
October 1, 2019
Sysmex, LabCorp extend hematology automation pact
The new XN-9100 is a scalable, modular automation system incorporating Yaskawa sample-sorting robotics. The system reduces turnaround time, improving labor utilization and maintaining high-quality patient results. It features a smaller footprint that frees laboratory space for other operational needs, the companies said in a statement.
September 25, 2019
Adaptive partners with Illumina for IVD test kits
The new test kits will expand the availability of Adaptive's clonoSeq assay for assessing and monitoring minimal residual disease (MRD) to manage patients with certain blood cancers. It will also expand the availability of the immunoSeq Dx assay for pipeline applications.
September 23, 2019
FDA approves Roche's cobas babesiosis test for blood donations
The in vitro screening test is designed for use with the company's 6800/8800 systems. Roche noted that the test is compliant with May 2019 guidance from the FDA regarding screening and testing blood donations for Babesia microti, a tick-borne, microscopic parasite that infects red blood cells.
September 19, 2019
Amgen enlists Adaptive's clonoSeq in broad blood cancer deal
MRD-negativity is an increasingly important marker of treatment response in cancer drug development. Per the deal, Adaptive will provide MRD testing and analysis to inform Amgen's drug development and receive annual development fees, sequencing payments, and milestone payments.
September 18, 2019
Sysmex drives Clinical Lab 2.0 anemia project
Clinical Lab 2.0 is backed by the Project Santa Fe Foundation, which was founded in 2016 by Geisinger Health, the Henry Ford Health System, Northwell Health, and TriCore Reference Laboratories. The initiative supports multi-institutional demonstration projects that show the value of lab diagnostics to reduce healthcare costs on a global scale.
September 15, 2019
Instrumentation Laboratory gets POC group purchasing deal
The deal covers three products: Rotem delta for viscoelastic testing; VerifyNow, which tests for platelet reactivity; and Hemochron Signature Elite for whole blood hemostasis. Instruments, reagents, supplies, and technical support are part of the deal, the companies said in a statement.
September 4, 2019
Fisher set to market Verax platelet contamination test
The test is used to detect bacterial contamination in apheresis platelets in plasma to ensure the safety of blood transfusions. It can be used to extend platelet dating, which potentially saves money by allowing the extended use of products that may otherwise need to be thrown away, according to the company. The product had been distributed by Fenwal/Fresenius Kabi, which is focused on distribution in blood centers, whereas Fisher Healthcare has a large presence in thousands of hospitals, an important target market for Verax, the company explained in a statement.
August 19, 2019
AACC: Inflammatix sepsis test wins Disruptive Technology contest
In the second annual edition of the competition, the company's HostDx Sepsis test for detecting sepsis won the majority of votes from an expert panel of five judges, as well as the audience participation vote. Inflammatix CEO Dr. Tim Sweeney, PhD, accepted a $5,000 prize on behalf of the Burlingame company for winning the award.
August 5, 2019
AACC: Pathologist flags need for transgender reference values
The retrospective study examined lab test results from charts of 147 healthy transgender people over five years, including a comprehensive metabolic panel, complete blood count, and lipids.
August 5, 2019
Fetal sickle cell blood test makes progress
With the test, they successfully analyzed fetal samples taken from the maternal bloodstream of carriers of sickle cell disease, an inherited condition caused by a mutation in the hemoglobin gene. The researchers from Guy's and St. Thomas' National Health Service (NHS) Foundation Trust are working with Viapath in London and Nonacus in Birmingham to develop the test.
June 16, 2019
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