• The FDA has approved a test that helps in assessing the risk of tumor recurrence and long-term survival for patients with relatively high-risk breast cancer, made by Dako Denmark (Glostrup, Denmark). Dako says that the TOP2A FISH pharmDx is the first approved device to test for the TOP2A (topoisomerase 2 alpha) gene in cancer patients. The product is The TOP2A gene plays a role in DNA replication. The TOP2A FISH pharmDx test uses fluorescently labeled DNA probes to detect or confirm gene or chromosome abnormalities, a technology known as fluorescent in situ hybridization (FISH). Changes in the TOP2A gene in breast cancer cells mean there is an increased likelihood that the tumor will recur or that long-term survival will be decreased. The test is suitable for breast cancer patients who are premenopausal or for whom tumor characteristics, such as tumor size or lymph node involvement, suggest a higher likelihood of tumor recurrence or decreased survival. The product was studied in Danish patients who were treated with chemotherapy after removal of a breast tumor. The test is conducted on a small piece of the removed tumor, with the tissue then stained with the FISH chemicals and studied under a microscope.

• Isolagen (Exton, Pennsylvania) said that injections have been completed in the Phase III multi-center, double-blind, randomized, placebo-controlled clinical trials evaluating the Isolagen Therapy for the treatment of nasolabial folds, or wrinkles. Subjects have advanced to the follow-up period of the study. Isolagen also reported the completion of injections in the Phase II open label study designed to gather further safety and potential application information on the use of the Isolagen Therapy for the full face. The subjects in this study also have advanced to the follow-up period, it said. Isolagen is an aesthetic and therapeutic company.

• Olympus America (Center Valley, Pennsylvania) reported FDA approval of the ready-to-use PK blood grouping reagents for its Olympus PK7200 automated microplate system. The reagents standardize ABO/Rh testing on the PK7200 and are convenient, economical, and efficient. The new antisera and reagent red blood cells are packaged in ready-to-use vials. No handling or manipulation of the reagents will be required other than transferring them to the appropriate locations on the PK7200 reagent boat. The color-coded reagents enhance process control, by enabling quick visual verification of reagent placement. The reagents are pre-qualified and standardized for optimal performance reducing variability of manually prepared reagents. The elimination of dilution studies provides lot-to-lot consistency and elimination of troubleshooting issues related to in-house manufactured reagents. Olympus America makes high-throughput automated blood bank instruments.

• Orthovita (Malvern, Pennsylvania) said it has made a 510(k) filing to the FDA for the use of its Cortoss bone augmentation material in vertebral augmentation, based on data from three U.S. clinical investigations conducted under FDA investigational device exemptions and several European studies and intended to demonstrate that the performance of Cortoss is substantially equivalent to polymethylmethacrylate (PMMA) bone cement. The clinical study of CORTOSS demonstrates that the same degree of clinical improvement in pain and function is achieved with approximately 40% less material than PMMA when augmenting the vertebral body, Orthovita said. The Cortoss filing includes data on 469 vertebral compression fracture patients treated with Cortoss and 94 patients treated with PMMA with follow up ranging from 11 months to over 3 years.

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