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LabCorp and Duke U, FDA, Bayer and Onyx, Miraculins and Fox Chase Cancer Center, OncoMethylome Sciences, Epigenomics and Stanford U, and Gentris and LGC

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LabCorp, Duke Launch Genomic Medicine Research Program

Laboratory Corporation of America Holdings said this week that it has begun a partnership with Duke University to create the "Duke-LabCorp Scholars in Genomic Medicine" program.

In a statement, the company described the partnership as an "important new relationship" that will help it "expand its opportunities to offer new genomic tests." Geoffrey Ginsburg of the Duke Institute for Genome Sciences & Policy will lead the effort.

The company said that the goal of the collaboration is to develop a "commercial partnership" that will drive genomic tests into clinical practice "as rapidly as possible," but did not provide further details.


FDA Grants Fast-Track Status to Bayer's and Onyx' Nexavar

The US Food and Drug Administration this week granted Nexavar, a product of Bayer Pharmaceuticals and Onyx Pharmaceuticals, fast-track status for the treatment of metastatic hepatocellular carcinoma, the companies said in a statement. Nexavar was approved in December for treating patients with advanced renal cell carcinoma.

Nexavar is a targeted therapy known to inhibit Kit, Flt3, PDGFR-B, VEGFR-2, VEGFR-3, and RAF kinase.


Miraculins to Validate Colorectal Biomarkers with Fox Chase Cancer Center

Miraculins, a cancer biomarker discovery firm, said this week that it will collaborate with Fox Chase Cancer Center to validate markers in a colorectal cancer diagnostic project. Miraculins picked up the biomarkers in its acquisition of Europroteome's IP portfolio last June.

Under the terms of the agreement, Fox Chase Cancer Center will provide a "significant number" of biological samples, which Miraculins will process with its BEST platform, which combines proteomic, mass spectrometric, and protein chemistry techniques for biomarker discovery.

The company said that its test has sensitivity and specificity of more than 80 percent.


OncoMethylome Sciences Discloses Plans for $44.2M European IPO

Belgian pharmacogenomics and molecular diagnostics company OncoMethylome Sciences last week disclosed details about its planned initial public offering in Europe.

The company expects the IPO to raise around €35 million ($44.2 million), which may be increased by 15 percent to cover any over-allotments. The price of each share is set between €7.50 and €10. The offer period began on June 12 and is expected to close on June 23.

Euronext Brussels and Euronext Amsterdam will list the shares on Eurolist under the symbol ONCO beginning June 27.

OncoMethylome plans to use the funds to support its growth, to increase its capitalization and financial flexibility, and to increase R&D activities. The cash will also be used for working capital and other general corporate purposes, the company said.

The shares will be offered to retail investors in Belgium and The Netherlands and to European institutional investors.

Fortis and ING have been appointed as joint bookrunners and joint lead managers, with Kempen & Co. as co-manager.


Epigenomics and Stanford to Study DNA Methylation in Cancer Research Collaboration

Epigenomics will collaborate with Stanford University in colorectal cancer research, the Frankfurt, Germany-based company said last week.

Under the agreement, Epigenomics and the Molecular Imaging Program at Stanford University will work with molecular imaging technologies and DNA methylation markers to determine the potential complementary benefits in early colon cancer diagnosis.

Traditional scans have a sensitivity of about 85 percent and a specificity of 71 percent in the initial diagnosis while the DNA methylation marker from Epigenomics has a sensitivity "between 50 and 65 percent" and a specificity of 95 percent, Cathy Lofton-Day, vice president of molecular biology at Epigenomics, said in a statement.

The study will combine both methods to increase sensitivity and specificity of colorectal cancer detection. Up to 120 patients will be enrolled in the study over a period of several months in a two-arm design. Up to 60 patients with confirmed colorectal cancer will be in one arm and up to 60 with other malignancies will be in the second arm.

The study is co-funded by Roche Diagnostics and Epigenomics.


Gentris Licenses LGC's CYP450 Polymorphism for Use in Genotyping Service

Gentris has taken a non-exclusive license from LGC for a common drug-metabolism polymorphism, the companies said last week.

According to the terms of the agreement, Gentris gains the rights to make, use, and sell diagnostic products and services that rely on LGC's CYP450 2D6*4 polymorphism.

Gentris plans to use the polymorphism in its genotyping service, CEO Michael Murphy said.

LGC is the exclusive licensor of the polymorphism.

The *4 polymorphism is the most common CYP450 2D6 polymorphism in Caucasians, and the 2D6 gene itself is believed to be involved in the metabolism of about 30 percent of approved drugs.

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