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Regulatory Approval: Page 5
Bluejay teams up with Toray on COVID-19 point-of-care test
By
LabPulse.com staff writers
Toray's Symphony interleukin 6 (IL-6) technology is a portable test for quantitation of IL-6 in whole blood for COVID-19 patients who present progressing symptoms and have a high risk of needing intubation with mechanical ventilation, according to Bluejay.
December 7, 2020
Exact to acquire early cancer detection firm for $2B
By
LabPulse.com staff writers
Thrive has developed CancerSeek, a blood-based cancer detection test that utilizes mutation and protein biomarkers. An early-stage version of the liquid biopsy detected 10 different types of cancer, including seven with no recommended screening guidelines, Exact noted.
October 27, 2020
Baxter, BioMerieux make deal on kidney test
By
LabPulse.com staff writers
The Nephrocleartm CCL14 test is in development for use in assessing the risk of developing persistent severe acute kidney injury (AKI). The agreement is part of a previously announced collaboration between the companies to improve identification and treatment of AKI.
September 15, 2020
World market outlook: COVID-19 testing evolves rapidly, lessons sink in
By
Justin Saeks
Worldwide, COVID-19 testing volume was on target to grow 25%-30% from May to June. New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods.
June 28, 2020
Emerald Organic, Todos Medical team on COVID-19 tests
By
LabPulse.com staff writers
Emerald will own 51% of Corona Diagnostics, while Todos will own the remaining 49%. Emerald Organic also will contribute financing, U.S. domestic distribution support, and assistance with U.S. healthcare standards and regulatory requirements.
March 25, 2020
Hologic to jettison Cynosure aesthetics business
By
LabPulse.com staff writers
The transaction comes at a steep discount from what Hologic paid to acquire Cynosure in 2017. That deal cost Hologic $66 per share in cash for a total value of approximately $1.65Â billion and an enterprise value of $1.44Â billion net of cash.
November 19, 2019
Lexent Bio partners on NGS with Illumina
By
LabPulse.com staff writers
Confera Dx is designed to monitor treatment response and the level of minimal residual disease (MRD) in cancer patients. The company plans to launch the product as a laboratory-developed test (LDT) with testing done at its own CLIA lab, and Lexent will also pursue clearance by the U.S. Food and Drug Administration (FDA) to enable use in the local labs of hospitals and health systems.
November 7, 2019
Adaptive partners with Illumina for IVD test kits
By
LabPulse.com staff writers
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
AACC calls for joint effort to tackle opioid epidemic
By
LabPulse.com staff writers
The number of fatal overdoses caused by synthetic opioids increased by 46% in the U.S. from 2016 to 2017 and formed a large proportion of the roughly 70,000 drug overdose deaths in 2017, according to the AACC. Clinical laboratories have the experts, tools, and tests to identify synthetic opioids that are otherwise generally missed.
August 4, 2019
Sysmex gets CE Mark for XN-31 hematology analyzer
By
LabPulse.com staff writers
XN-31 offers hematology parameters typically used for blood testing, but it can also determine via automatic measurement in about one minute whether red blood cells are infected by malaria parasites. Current malaria testing is performed using microscopes or rapid diagnostic tests, the company noted.
April 25, 2019
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