• Genomic Health (Redwood City, California) said that its QUASAR validation study met its primary endpoint to predict the likelihood of recurrence for stage II colon cancer patients following surgery, and that the colon cancer Recurrence Score provided additional independent clinical value beyond standard measures of risk. Based on these positive results, Genomic Health is initiating the necessary work in its Clinical Reference Laboratory and proceeding with commercialization plans to make the Oncotype DX colon cancer Recurrence Score available to physicians and patients in early 2010. While meeting the primary endpoint in predicting recurrence, the study did not meet a second endpoint evaluating a separate score, with a distinct set of genes, designed to predict which patients experience greater relative benefit of 5-fluorouracil/leucovorin (5FU/LV) following surgery.

• GI Dynamics (Lexington, Massachustts) reported that new data on its EndoBarrier platform will be presented at the upcoming SAGES and ECO meetings. The EndoBarrier creates a physical barrier that lines the intestine to keep food from coming in contact with the intestinal wall. Physicians believe this may alter the activation of hormonal signals that originate in the intestine, and may mimic the effects of a Roux-en-Y gastric bypass procedure. However, the EndoBarrier procedure is done without the risks associated with highly invasive surgical procedures. The EndoBarrier is placed and removed endoscopically (via the mouth) without the need for surgical intervention or alteration of the patient's anatomy.

• HydroCision (Billerica, Massachusetts) reported the launch of the SpineJet DL fusion handpieces for the new minimally invasive direct lateral fusion procedure. The company's family of fluidjet products empowers surgeons to simultaneously cut, ablate, and remove hard and soft tissue quickly, safely, and effectively – without the collateral thermal or mechanical trauma of other surgical modalities.

• Olympus (Center Valley, Pennsylvania) has received FDA clearance for a Carcinoembryonic Antigen (CEA) test for the Olympus AU3000i immunoassay system. CEA is assigned to a group of markers indicating the presence of carcinomas such as those present in the colon. The Olympus CEA assay is a two-step paramagnetic particle enzyme immunoassay with a measuring range of approximately 0.08-500 ng/mL. It measures quantitative concentrations of CEA in 50 microliters of either serum or lithium-heparin plasma samples after 28 minutes of processing time. Samples containing CEA concentrations exceeding 500 ng/mL are auto-diluted onboard (1:1000) for a clinical reportable range of approximately 500,000 ng/mL. Each CEA kit is sufficient to process 200 tests, and contains CEA reagents, a single ready-to-use calibrator, and a single ready-to-use control. Reagents are stable onboard the AU3000i system for 28 days.

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