Presentations Related to ImmunoGen, Partner ADCs
•“Development and application of an immunohistochemistry-based clinical assay for evaluating Folate Receptor Alpha (FRα) expression in a phase I clinical trial of IMGN853.” Abstract number: 4357
•“Plasma pharmacokinetics and tumor accumulation in mice of IMGN779, an antibody-drug conjugate for acute myeloid leukemia.” Abstract number: 4504
•“In vitro and in vivo activity of a highly potent and novel FGFR2/FGFR4 dual targeting antibody-drug conjugate.” Abstract number:1680
•“Development and activity of a novel antibody-drug conjugate for the treatment of P-cadherin expressing cancers.” Abstract number: 1682
•“A novel anti-CEACAM5 maytansinoid-antibody-drug conjugate for the treatment of colorectal, lung and gastric tumors.” Abstract number: 1688
•“Generation of a novel maytansinoid-antibody-drug conjugate targeting LAMP1 expressed on the surface of tumor cells.” Abstract number: 1689
•“Development of a novel antibody-drug conjugate for the treatment of c-Kit expressing solid tumors and AML.” Abstract number: 1695
•“A c-Kit targeting antibody-drug conjugate is efficiently metabolized and activated inside cancer cell lines and xenograft tumors.” Abstract number: 5325
On August 5, 2014 the U.S. Secretary of Health and Human Services declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection of Ebola virus. Cepheid's Xpert Ebola has not been FDA cleared or approved, but will remain available in the U.S. as an EUA product as long as the declared emergency remains in effect or it ceases to be authorized by FDA.
"With support from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation (provided via the National Philanthropic Trust Fund for Global Health and Development), Cepheid was able to leverage its extensive development experience to expedite delivery from the initial prototype to an emergency use only product in just 90 days," said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. "We expect that this technology will help to expedite the evaluation of suspected cases and to enable more effective field surveillance activities already underway in endemic areas."
Xpert Ebola has been authorized by FDA under an Emergency Use Authorization for use by CLIA moderate and high complexity laboratories or similarly qualified non-U.S. laboratories.
SUNNYVALE, Calif., March 24, 2015 /PRNewswire/ --
Cepheid (CPHD) today announced it has received Emergency Use Authorization from the U.S. Food & Drug Administration (FDA) for Xpert® Ebola, a molecular diagnostic test for Ebola Zaire Virus that delivers results in less than two hours. The test runs on the Cepheid GeneXpert® Systems, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.
"We developed Xpert Ebola with a dual-target design to ensure high-accuracy and sensitivity for detecting the Ebola Zaire virus, detected in the West Africa outbreak in 2014. The test runs in Cepheid's self-contained cartridge to minimize potential contamination," said John Bishop, Cepheid's Chairman and CEO. "Cepheid has historically played a leading role in developing molecular diagnostics as an aid to infection control efforts, and the current Ebola crisis represents an extreme example of the need for sensitive, fast, and easy to use diagnostics to aid in patient management and isolation requirements. We believe this is a major step in strengthening the arsenal of tools being deployed to address the current situation."