Luminex Corporation (NASDAQ: LMNX) recently announced that norovirus will be the fourth assay in the launch menu for its new sample-to-answer system, ARIES™. The assay is designed to test for both GI and GII genogroups in a single, easy-to-use cassette. The previously announced items in the five assay launch menu targeted for the ARIES system also include: Flu A&B/RSV, HSV 1&2, and Clostridium difficile (C. diff). Future menu items will be announced at a later date.
Luminex Corporation Announces Norovirus as a Launch Menu Assay for its New Sample-to-Answer System, ARIES
The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.
Genomic Health Announces Presentation of Oncotype DX Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers
Genomic Health, Inc. (Nasdaq: GHDX) recently announced results from four studies highlighting the value of its Oncotype DX® tests for optimizing treatment for patients with breast and colon cancer. Three new decision impact studies – including the company’s first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test’s significant impact on breast cancer treatment decisions in the United Kingdom (UK) – were among data presented at the European Cancer Congress 2013 in Amsterdam. The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX “as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer.”
Venaxis, Inc. (Nasdaq: APPY), an in vitro diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked APPY1 Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, recently announced that the external Data and Safety Monitoring Board (DSMB) created as part of the Company’s pivotal clinical trial for the APPY1 Test has recommended continuation of the pivotal clinical trial, based upon completion of the first of two futility analyses included in the clinical trial design. Venaxis will host a conference call and webcast tomorrow morning, July 16, 2013, at 8:30 a.m. ET, to discuss the DSMB’s recommendation and to provide a general corporate update.
Sanofi Announces Upcoming Launch of MyStar Extra, the First Self-Monitoring Blood Glucose Meter With Estimated A1c
At the annual meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain, Sanofi (EURONEXT : SAN and NYSE : SNY) recently presented the innovative blood glucose meter MyStar Extra®, the first self-monitoring device that provides robust estimates of the A1c value, a key indicator for long-term glucose control., The hemoglobin A1C (HbA1C) assay has become the cornerstone for the assessment of diabetes control and A1c test results are widely used to guide treatment decisions., Especially convenient for people starting on insulin or using insulin, MyStar Extra® is a supportive meter, designed to help people with diabetes be engaged in their insulin management and treatment plan.,,