• Exagen Diagnostics (Albuquerque, New Mexico) said that it filed for FDA review of the first of six products currently in its product pipeline. This product, eXagenBC, is a DNA-based test that identifies risk of recurrence in breast cancer patients and allows physicians to more accurately predict prognostic outcome. Exagen makes genomic marker-based in vitro diagnostic kits that provide diagnostic and prognostic information allowing targeted treatments and assisting physicians.

• Gen-Probe (San Diego) said that a research test for the specific prostate cancer gene PCA3 in urine predicted the results of repeat biopsies more accurately than traditional prostate specific antigen (PSA) testing, as reported in the March issue of Urology. Gen-Probe’s PCA3 research test detects the over-expression of PCA3 mRNA in urine. Previous studies have shown that PCA3 is over-expressed, relative to benign cells, by 60- to 100-fold in more than 90% of prostate tumors, indicating that the gene may be a useful biomarker for prostate cancer. In contrast, serum PSA may be elevated due to a number of benign conditions, resulting in “false positive” results and unnecessary biopsies. Gen-Probe makes nucleic acid tests that are used primarily to diagnose human diseases and screen donated human blood.

• KARL STORZ Endoscopy-America (Culver City, California) reported the installation of fully functional integrated operating rooms combined with intraoperative magnetic resonance imaging (iMRI) capabilities at Cook Children’s Medical Center (Fort Worth, Texas) and Swedish Medical Center (Seattle). The system at Cook Children’s is the first installation of its kind to comprise a fully integrated OR (rather than a cart-based system) and to use all-digital high-definition video technology. All images, including PACS, vital signs, endoscope and microscope images, utilize the highest native resolutions. The installation at Swedish is similar to the one at Cook Children’s, except the magnet is fixed in the operative field. KARL STORZ Endoscopy-America, an affiliate of KARL STORZ GmbH & Co. KG, makes minimally invasive endoscopic technologies and OR integration.

• Masimo (Irvine, California) reported that three new independent studies concluded that Masimo acoustic respiratory monitoring technology (ARM) is “at least as accurate as capnometry” and “significantly more reliable” for monitoring respiration in spontaneously breathing patients.” Two studies released in January at the 2007 Society for Technology in Anesthesiology annual meeting, concluded that Masimo’s new bioacoustic respiratory sensor “demonstrates accuracy for respiratory rate monitoring as good as capnometry” and that the device “offers multiple benefits over existing devices and has a potential to improve monitoring in a general care setting.” Masimo makes monitoring products.