November 2008 Clinical Laboratory News: Industry Profiles

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November 2008: Volume 34, Number 11

 Sequenom Buys Center for Molecular Medicine

San Diego-based Sequenom announced a $4 million deal to acquire the Center for Molecular Medicine (CMM), a Grand Rapids, Mich.-based joint venture between Spectrum Health and the Van Andel Research Institute. Headed by Daniel Farkas, PhD, CMM is an advanced molecular pathology lab created to help advance cutting-edge diagnostics, translational research, and clinical trials. As part of the deal, CMM will enter into collaborative agreements with Spectrum Health and the Van Andel Research Institute. “We believe CMM’s expertise in molecular diagnostic testing and its relationship with a key healthcare system with the stature of Spectrum Health, as well as the Van Andel Research Institute’s innovative genomic and translational research capabilities, will be a valuable and complementary additions to Sequenom,” said Harry Stylli, PhD, president and CEO of Sequenom. “This acquisition positions us well to successfully launch our SEQureDx Trisomy 21 Down syndrome test through a CLIA-certified lab.”

Breast Cancer Test Gets Evaluated at Dana-Farber Cancer Institute

Monogram Biosciences announced a collaboration with the Dana-Farber Cancer Institute to evaluate Monogram’s HERmark breast cancer assay in metastatic breast cancer. The assay will be used to analyze about 600 tissue samples from patients with breast cancer, approximately half of whom were eligible for treatment with Herceptin based on prior HER2 IHC or FISH testing. “Results from prior studies have suggested that HERmark can identify subsets of patients with different responses to Herceptin even though they had all been previously assessed as ‘HER2-positive’ by IHC or FISH,” said Michael Bates, MD, vice president of research for Monogram. The aim of the study is to test the hypothesis that HERmark selects patients for Herceptin treatment in the metastatic setting better than other currently available assays, as well as to test cutoff values that have been previously defined for HERmark. Bates said that the study will also measure HER3 expression levels in the tumors to see if they correlate with clinical outcomes in the cohort. The study gives the company enough tissues to test assays that are in development, including assays for HER1 expression, p95 expression, and heterodimers of HER2.


Luminex and BD Ink Agreement for Cancer Tests 

Luminex and BD announced a development and supply agreement under which BD will develop and market new biomarker-based tests for cancers using the Luminex xMAP system, a multiplexing platform that allows multiple, simultaneous tests per sample. “We believe providing biomarker testing in a multiplex format would allow detection of cancer at an earlier stage,” said Wayne Brinster, vice president and general manager of BD Diagnostics-TriPath. “This valuable information allows clinicians to begin treatment sooner, which has been shown to improve outcomes.” Financial terms of the agreement were not disclosed.

Focus Gets Rights to Asuragen’s Armored RNA 

Asuragen and Focus Diagnostics announced a deal whereby Asuragen will develop and supply reagents for Focus Diagnostics using its proprietary Armored RNA technology. This process packages RNA standards in a protective protein coat to assure the standard’s integrity during long term storage and against nucleases in patient samples. Armored RNA was jointly invented and developed by Asuragen and Cenetron Diagnostics. Financial terms of the deal were not disclosed.

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