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  • NICHD Study To Test Surgical Technique to Repair Spinal Defect Before Birth
    The National Institute of Child Health and Human Development (NICHD) will conduct a large study to determine whether a new surgery to correct spina bifida in the womb is safer and more effective than the traditional surgery to correct the disorder, which takes place a few days after birth. Spina bifida is a complex, often severe birth defect of the spinal cord that affects one of every 1000 pregnancies in the United States. In this condition, the spinal cord and the bones of the spinal column...
    National Institutes of Health
  • FDA CLEARS NEW LAB TEST FOR GROUP B STREP IN PREGNANT WOMEN
    The Food and Drug Administration today cleared for marketing a new laboratory test for Group B Streptococcus in pregnant women. The new test, the IDI-Strep B test, made by Infectio Diagnostic, Inc., of Quebec, can provide results in one hour, if facilities can provide round-the-clock testing. In contrast, the standard method of culture testing takes 18 to 48 hours for results. The new test is performed using a Cepheid Smart Cycler instrument on a swab sample taken from the vagina and rectum....
    U.S. Food and Drug Administration
  • The Prostate-Specific Antigen (PSA) Test: Questions and Answers
    Key Points Prostate-specific antigen (PSA) is a protein produced by the cells of the prostate gland. The PSA test measures the level of PSA in the blood (see Question 1). The U.S. Food and Drug Administration (FDA) has approved the use of the PSA test along with a digital rectal exam to help detect prostate cancer in men age 50 and older. The FDA has also approved the PSA test to monitor patients with a history of prostate cancer to see if the cancer has come back (recurred) (see Question 2)....

  • FDA Clears New Lab Test to Help Rule Out Heart Attack
    The Food and Drug Administration (FDA) today cleared for marketing a new laboratory blood test that will significantly increase the ability of doctors to rule out a heart attack when a person shows up at an emergency room with severe chest pains. The test is the first new blood test for evaluation of heart attacks since the introduction of the blood test for troponin, a protein present in the blood after a heart attack, in 1994. The test, the Albumin Cobalt Binding (ACB) Test, manufactured by...
    U.S. Food and Drug Administration
  • FDA Clears Rapid Test for Aspergillus Infection
    The Food and Drug Administration (FDA) today cleared for marketing the first rapid laboratory test for a life-threatening invasive fungal infection that occurs in leukemia patients, organ and bone marrow transplant patients, and patients whose immune systems are compromised by illness or chemotherapy. The test will allow doctors to diagnose invasive aspergillus infection quicker and begin treatment with anti-fungal drugs sooner. The new test, the Platelia Aspergillus EIA, manufactured by...
    U.S. Food and Drug Administration

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December 2, 2009



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