• In findings that could eventually change the way breast cancer is treated, a study reports that the BluePrint (Irvine, California) genomic test provides more accurate information about the molecular subtype of breast cancer than does conventional IHC-FISH pathology testing. The results were reported at the recent American Society of Clinical Oncology (ASCO) 2014 Breast Cancer Symposium. The prospective observational study of 515 patients showed that the 80-gene BluePrint test reclassified 22% of tumors overall – meaning that it more accurately identified breast cancer subtypes than did the IHC-FISH tests. Based on these results, researchers concluded that the BluePrint assay may be superior to IHC-FISH testing for guiding physicians' decisions about how to treat their patients' early-stage breast cancers before surgery. "This genomic test gives us a better picture of which patients will and won't respond to preoperative therapy, and also helps suggest the best course for therapy," said Pat Whitworth, a Nashville surgical oncologist and lead study author. "One implication of the study findings is that we will eventually end up evaluating and treating many breast cancer patients differently than we do now, because we will rely on their molecular subtype rather than just IHC-FISH pathology results."

• NxStage Medical (Lawrence, Massachusetts), a maker of dialysis products, said its single needle technology, OneSite, has received FDA clearance. The OneSite uses a unique dual lumen needle design offered in both a sharp version with MasterGuard and a buttonhole version with SteriPick allowing the dialysis patient to have only one needle inserted per dialysis treatment instead of two. The combination of single site and buttonhole access is designed to provide patient comfort during needle insertion and dialysis treatment, as well as preservation of the patient's vascular access. The dual lumen design also enhances patient safety during treatment by having the machine alarm and shutdown upon access dislodgement, reducing the risk of undetected Venous Needle Dislodgement (VND) in the use of a two needle treatment. The NxStage System One is the first and only truly portable hemodialysis system cleared for home use by the FDA. Its simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy.

• Spineology (St. Paul, Minnesota), a maker of anatomy conserving spine surgery, reported the full release of its VIA Spinous Process Fixation system. The company claims the VIA is the first and only Spinous Process Plate with independently compressible superior and inferior plates that are contoured to maximize the fit between the implant and the spinous processes and associated laminae.

• Trice Medical (King of Prussia, Pennsylvania), a private diagnostics company focused on micro invasive technologies, received FDA regulatory clearance from the FDA for its new device, mi-eye. mi-eye is designed to provide a more immediate, definitive and less expensive diagnosis, eliminating the false reads of indirect modalities, such as MRIs. mi-eye is a fully disposable, single-use, streamlined visualization device that uses a standard 14-gauge needle with an integrated camera and light source to perform a diagnostic arthroscopy--all while in the physician's office during the initial consultation. A separate LCD tablet, running on Android OS, is attached via a data cable from the mi-eye needle. mi-eye is delivered to customers in sterile packaging and ready for immediate use. Trice intends to execute a limited marketing launch beginning in 4Q14. The company is currently building inventory and developing marketing tools and educational programs in preparation for the launch.