Regulatory Approval: Page 3

FDA approves marketing of BioFire COVID-19 test
The diagnostic test had emergency use authorization and received approval for marketing through the FDA's "de novo" pathway, a regulatory pathway for low- to moderate-risk devices of a new type. The de novo request was based on additional data showing validation beyond what is needed for emergency use authorization.
March 17, 2021
2020 07 16 23 29 1615 Laboratory Scientist Biosafety 400
Bluejay teams up with Toray on COVID-19 point-of-care test
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
2019 11 15 22 54 6305 Business Hands 400
Exact to acquire early cancer detection firm for $2B
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
2020 05 15 23 50 8470 2020 05 14 Bloodtest 400
Baxter, BioMerieux make deal on kidney test
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
2020 01 16 18 27 4229 Kidney 400
World market outlook: COVID-19 testing evolves rapidly, lessons sink in
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
2020 05 05 21 16 5661 Coronavirus Global Spread 400
Emerald Organic, Todos Medical team on COVID-19 tests
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
2020 03 24 23 17 4026 Virus Coronavirus Global 400
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Genetic causes identified for three rare diseases
Researchers in study validate test to identify newborns with homocystinuria, a rare inherited disease
SARS-CoV-2 infection weakens immune-cell response to vaccination, study suggests
Duke University researchers discover biomarkers may identify early pancreatic cancer risk
Werfen completes $2B acquisition of Immucor, expands presence in specialized diagnostics
Chembio CEO urges stockholders to tender remaining shares as deadline is extended for acquisition
Hologic to jettison Cynosure aesthetics business
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 $1.65 billion and an enterprise value of $1.44 billion net of cash.
November 19, 2019
2019 08 20 21 43 1377 Hologic Aacc 2019 400
Lexent Bio partners on NGS with Illumina
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
2019 05 10 17 42 3167 Lab Doctors Dna 400
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
2019 08 02 16 42 5947 Lab Blood Man 400
AACC calls for joint effort to tackle opioid epidemic
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
2019 08 05 19 09 1932 Bottle Pills 400
Sysmex gets CE Mark for XN-31 hematology analyzer
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
2019 04 25 22 25 7606 Sysmex Xn 31 Hematology 20190425223850
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