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Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

bioTheranostics’ Breast Cancer IndexSM Molecular Test Identifies Risk for Early and Late Breast Cancer Recurrence, Lancet Oncology Study Finds

A study published online in The Lancet Oncology found that in a comparison of three methods of predicting the risk of recurrence of estrogen-receptor (ER)-positive breast cancer, only the Breast Cancer IndexSM (BCI) from bioTheranostics predicts risk for both early (0-5 years) and late (5-10 years) recurrence. The study provides important new information to guide patient treatment decisions at diagnosis and after several years of therapy.

The Ongoing Collaboration Aims to Exploit the High Throughput, Robustness and Ease of Use of MALDI-TOF Instruments

At the 12th HUPO World Congress, Bruker Corporation (NASDAQ: BRKR) recently announced the start of a second-phase collaboration agreement with SISCAPA Assays Technologies, Inc. (SAT). The ongoing collaboration aims to exploit the high throughput, robustness and ease of use of MALDI-TOF instruments as an alternative to nano-LC-MS technology currently used in many SISCAPA assays.

Study Published Showing Advantages of the PAM50 Gene Signature, the Basis for Prosigna, in Helping to Estimate Risk of Late Distant Recurrence in Postmenopausal Estrogen Receptor Positive Breast Cancer Patients

NanoString Technologies, Inc., (NASDAQ: NSTG) a provider of life science tools for translational research and molecular diagnostic products, recently announced that a study published online in the Journal of the National Cancer Institute demonstrated that the PAM50 gene signature, which is the basis for the Prosigna™ Breast Cancer Prognostic Gene Signature Assay, provides important information to help estimate the risk of late distant recurrence in postmenopausal women with estrogen receptor positive (ER+) early-stage breast cancer. After comparing the PAM50 gene signature, the Oncotype DX® Breast Cancer Assay and the IHC4 score, the authors concluded that the PAM50 gene signature provided the strongest prognostic information regarding risk of distant recurrence five to 10 years following diagnosis in postmenopausal ER+ early-stage breast cancer patients treated with five years of endocrine therapy.

Definiens and Advanced Cell Diagnostics Launch Software for Quantitative RNA In Situ Hybridization

Definiens AG, a healthcare company that advances personalized medicine through image analysis and digital pathology solutions, and Advanced Cell Diagnostics (ACD) of Hayward California, a leader in molecular pathology, announced recently the commercial launch of RNAscope® SpotStudio™, a custom-designed image analysis software application for ACD’s RNAscope®Assays to detect and quantify RNA biomarkers. By combining state-of-the-art image analysis and advanced in situ hybridization technologies, gene expression can be measured quantitatively at single cell resolution and interpreted by pathologists within context.