�The clinical laboratory company LabCorp is offering a new blood test aimed at detection ovarian cancer the Crab at an early and still treatable stage, merely the test is organism met with concern among many physicians and medical organizations, the New York Times reports. According to the Times, the Society of Gynecologic Oncologists issued a statement saying it did non believe the test, called OvaSure, had been validated enough for routine use. The Times reports that a number of sophisticated diagnostic tests are entering the mart and beingness used as the basis for crucial treatment decisions. The article also notes that the debut of OvaSure raises the query of whether greater regulation of symptomatic tests is needed. OvaSure was non reviewed by FDA because the agency does not regulate tests developed and performed by a single laboratory. However, FDA in an Aug. 7 varsity letter sent to LabCorp that was posted on the FDA site asked LabCorp for a discussion on OvaSure's test results and research data, saying that the company "is offering a high-risk test that has non received tolerable clinical establishment and may harm the public health," the Times reports.
The essay was developed at Yale University and has been offered by LabCorp since late June. According to the Times, the test measures the level of six proteins in profligate samples, some produced from a tumour and others produced by the body's reaction to the neoplasm. The test then calculates a probability that the woman has ovarian crab. The test correctly classified 221 of 224 blood samples taken from women with ovarian cancer or from controller groups, according to a study published in the February issue of the journal Clinical Cancer Research. The study also ground that the test's untrue positive charge per unit was 0.6% and that 95% of cancers were identified. However, according to Beth Karlan, managing director of the Women's Cancer Research Institute at Cedars-Sinai Medical Center, there were few samples from women with early stages of the virtually deadly type of ovarian cancer and, therefore, the samples tried did non adequately represent what mightiness be ground in routine screening (New York Times, 8/26).
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