The latest in medical products for obstetrics and gynecology.
Fewer false negatives is goal of newly cleared Pap test
The goal of more comprehensive cell specimen collection is to cut the rate of false negatives, leading to earlier cervical cancer treatment, CytoCore says, adding that there's less trauma to the cervix and less bleeding and spotting than with traditional methods.
The FDA approves Avastin for metastatic HER2-negative breast ca
The FDA has granted accelerated approval to Genentech's targeted biological agent Avastin (bevacizumab)-already approved for colorectal and lung cancers in combination with chemotherapy-for first-line therapy of metastatic HER2-negative breast cancer, when used in conjunction with paclitaxel. The approval was based on progression-free survival, a less stringent criterion than the increased overall survival benefit that's required for non-life threatening diseases.
In 2006, the FDA had turned down the company in its previous try for approval of this indication. The decision this time was based on a clinical trial in which patients who received Avastin along with paclitaxel experienced no worsening of their cancer for a median of 11.3 months (vs. 5.8 months for those receiving paclitaxel alone). And although the Avastin group survived a median of 26.5 months-1.7 months longer than the paclitaxel-alone women-results were not statistically significant.
For more information, visit http://www.fda.gov/.
Only FDA-cleared home detection test for leaking amniotic fluid
Although pH levels of 5.2 or greater will produce a blue-green color that stays stable for at least a week (unlike fluids such as urine, which reverse color changes within 30 minutes), home-users are told to report all positive or negative results to you for interpretation.
For more information about the kit, which wholesales for $46.88, call 1-877-Amni-Kit (1-877-266-4548) or visit the company's Web site at http://www.amniscreen.com/, where you can download a brochure.