45 documents

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18:54 , Oct 27, 2017 |  BC Week In Review  |  Company News

Fujirebio developing companion diagnostic for Morphotek's farletuzumab

The Morphotek Inc. subsidiary of Eisai Co. Ltd. (Tokyo:4523) granted Fujirebio Inc. (Tokyo, Japan) exclusive, worldwide rights to develop and commercialize the CA125 II assay as a companion diagnostic to identify ovarian cancer patients who...
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21:00 , Jun 22, 2017 |  BC Innovations  |  Targets & Mechanisms

Exosomes deliver

Codiak BioSciences Inc. founder Raghu Kalluri has published the first animal data demonstrating exosomes can be used as drug delivery vehicles to treat cancer -- not just diagnose it. The findings also mark the unveiling...
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07:00 , May 27, 2013 |  BC Week In Review  |  Company News

Cizzle Biotechnology, Fujirebio deal

Cizzle and Fujirebio's Fujirebio Diagnostics Inc. will co-develop Cizzle's blood test that detects a variant of CDKN1A interacting zinc finger protein 1 (CIZ1) to diagnose early stage lung cancers. The companies will develop a simplified...
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07:00 , Apr 15, 2013 |  BC Week In Review  |  Clinical News

ARCHITECT Galectin-3 test regulatory update

BG Medicine said partner Abbott Laboratories (NYSE:ABT, Abbott Park, Ill.) received CE Mark approval for the ARCHITECT Galectin-3 test, an automated version of BG Medicine's BGM Galectin-3 test that is marketed as an aid in...
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07:00 , Apr 1, 2013 |  BC Week In Review  |  Clinical News

ARCHITECT Galectin-3 test regulatory update

BG Medicine disclosed in its 2012 earnings that partner Fujirebio Inc. (Tokyo, Japan) withdrew a 510(k) application for the ARCHITECT Galectin-3 test, an automated version of BG Medicine's BGM Galectin-3 test that is marketed as...
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08:00 , Dec 3, 2012 |  BC Week In Review  |  Company News

Fujirebio, Thermo Fisher deal

Thermo Fisher and Fujirebio partnered to make Thermo Fisher's Procalcitonin biomarker assay available on Fujirebio's Lumipulse family of laboratory instruments in Japan. The Procalcitonin assay is used to detect sepsis. The Lumipulse products use chemiluminescent...
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08:00 , Jan 23, 2012 |  BC Week In Review  |  Company News

Fujirebio, Laboratory Corp. of American Holdings, Abbott sales and marketing update

LabCorp launched the Risk of Ovarian Malignancy Algorithm (ROMA) stratification tool in the U.S. The tool combines Fujirebio's HE4 enzyme immunoassay (EIA) and Abbott's CA125II blood test results to aid in assessing the risk of...
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07:00 , Sep 12, 2011 |  BC Week In Review  |  Clinical News

HE4 enzyme immunoassay regulatory update

FDA granted 510(k) clearance for Fujirebio's HE4 enzyme immunoassay (EIA) to be used in combination with CA125 blood test results and the Risk of Ovarian Malignancy Algorithm (ROMA) to aid in assessing the risk of...
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07:00 , Jun 6, 2011 |  BC Week In Review  |  Clinical News

CYFRA 21-1 EIA assay regulatory update

Fujirebio's Fujirebio Diagnostics Inc. unit received 510(k) clearance from FDA for its CYFRA 21-1 EIA assay to monitor disease progression in lung cancer patients. The biomarker assay kit that detects soluble cytokeratin 19 ( CK19...
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08:00 , Nov 8, 2010 |  BC Week In Review  |  Company News

GenMark Diagnostics, Miraca deal

GenMark received non-exclusive, U.S. rights to Innogenetics N.V.'s HCV genotyping IP and an option to obtain worldwide rights to the technology. GenMark will use the technology to expand its diagnostic test offerings. Financial terms were...
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