• Abaxis (Union City, California) said that the FDA has granted waived status under CLIA regulations for two additional analytes, Creatine Kinase (CK) and Phosphorus (Phos), when used by healthcare professionals in conjunction with the Piccolo and Piccolo Xpress point-of-care analyzers. The renal function panel is a standard panel mostly used for determination of renal function status. The MetLyte 8 is commonly used to assess a variety of metabolic conditions across several specialties, including pediatrics and cardiology. Abaxis specializes in portable blood analysis systems for use in any veterinary or human patient-care setting to provide clinicians with rapid blood constituent measurements.

• A study from the Netherlands Cancer Institute reported data uncovering a substantial group of traditionally miscategorized low-risk HER2+ patients. Agendia's (Amsterdam, the Netherlands) breast cancer tumor recurrence test, MammaPrint, was used to differentiate between patients at high and low risk for recurrence. HER2+ patients are commonly identified as high risk, yet MammaPrint was able to identify a low risk subgroup of HER2+ patients, who subsequently experienced a 10 year disease-free survival of close to 90% even in the absence of (neo)adjuvant trastuzumab (Herceptin) and chemotherapy. MammaPrint is the first FDA-cleared in vitro diagnostic multivariate index assay. It identifies patients with early metastasis – those who are likely to develop metastases within five years following surgery. Several authoritative studies have shown that chemotherapy particularly reduces early metastasis risk. In planning treatment, the MammaPrint test result provides a doctor with a clear rationale to assess the benefit of adjuvant chemotherapy in addition to other clinical information and pathology tests.

• Applied Precision (Issaquah, Washington) reported the introduction of a new imaging system that it said has twice the resolution of traditional microscopes. The DeltaVision|OMX system is based on the OMX microscopy system developed by scientists at the University of California, San Francisco and exclusively licensed to Applied Precision. The DeltaVision|OMX system solves two fundamental limitations that have frustrated scientists, spatial and temporal resolution. Over the past year, Applied Precision has built six early adopter DeltaVision|OMX systems into laboratories. These systems are aiding scientists studying HIV, neurological disease, cancer, DNA repair, gene regulation, and a host of other diseases and mechanisms.

• Exiqon (Copenhagen, Denmark) reported the launch of its first molecular diagnostic test based on miRNA. The miRNA-based prognostic test will help identify stage II colon cancer patients who may be at significantly higher risk for recurrence and for whom adjuvant chemotherapy may be warranted. Generally, stage II patients are not treated with adjuvant chemotherapy, yet up to 25% of them will recur. The new miRNA test identifies patients who are at increased risk for recurrence and thus helps guide physicians in making critical treatment decisions.

• Guided Therapeutics (Norcross, Georgia) said that it submitted the first of three modules of its PMA application to the FDA for the LightTouch, a non-invasive cervical cancer detection device. The LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately.