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FDA to regulate thousands of cancer, genetic and other diagnostics
The Food and Drug Administration unveiled plans to regulate thousands of diagnostic tests, including many coming from the exploding field of genetic research, to which it has until now turned a blind eye. More than 11,000 of these tests, known as laboratory-developed tests, created by 2,000 different laboratories, could be included in the new regulatory framework, according to the FDA. The agency made its plans public in a guidance document that was sent to Congress, as part of legal direction by legislators.
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J&J pulls hysterectomy tool tied to cancer risk from market
HealthDay News via
The largest maker of a surgical tool that has shown an increased risk of spreading undetected cancers in women has said it will withdraw its device from the market. In a letter that was to be sent to all of its customers, Johnson & Johnson asked that its laparoscopic power morcellators be returned to the company, the Wall Street Journal reported.
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US insurer to stop coverage of gynecological procedure
A health insurer with 5.2 million members in three Eastern U.S. states said it would stop providing coverage for a procedure called laparoscopic power morcellation that is used in gynecological surgery and may inadvertently spread cancer. Highmark, Inc., which has customers in Pennsylvania, Delaware and West Virginia, will stop covering the procedure on Sept. 1, company spokesman Aaron Billger said in an email.
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  ChemoFx Improves Ovarian Cancer Outcomes
ChemoFx® provides invaluable information to physicians choosing from 20+ equivalent treatment recommendations without prior knowledge of how individual patients may respond. ChemoFx determines platinum resistance in primary ovarian cancer and demonstrates longer overall survival by 14 months in recurrent ovarian cancer, making it instrumental in improving patient outcomes.


Repurposed drug used to treat ovarian cancer gives positive results
A repurposed drug originally used to treat ovarian cancer saw positive results for patients with advanced peritoneal cancers during a phase I clinical trial at The University of Kansas Cancer Center. The drug, known under the brand name Nanotax, is a fine particle reformulation of paclitaxel, the standard treatment for ovarian cancer. It works by flipping the script on how paclitaxel is administered to patients and with how it's formulated, potentially making it a more effective and better tolerated treatment for ovarian and other abdominal cancers.
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Oral contraceptive, breast cancer link varies by formulation
HealthDay news via Healthcare Professionals Network
Recent use of oral contraceptives is associated with increased breast cancer risk, which varies by formulation, according to a study published in the Aug. 1 issue of Cancer Research. Elisabeth F. Beaber, PhD, MPH, from the Group Health Cooperative in Seattle, and colleagues conducted a nested case-control study among females in a large U.S. health care delivery system. Data were examined for 1,102 patients, aged 20 to 49 years, diagnosed with invasive breast cancer from 1990 to 2009, and 21,952 matched controls randomly sampled from enrollment records.
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LabCorp loses another appeal over Pap smear expert witness
Daily Report (Free login required)
An Atlanta-based federal appeals court panel has rejected a laboratory testing company's challenge to expert testimony against it in a case alleging technicians missed a patient's cervical cancer.
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Hopkins agrees to pay $190 million to settle Levy claims
Baltimore Sun
Johns Hopkins Hospital has agreed to pay $190 million to settle claims from thousands of women who may have been surreptitiously recorded during pelvic exams by gynecologist Dr. Nikita A. Levy.
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In remission for ovarian cancer, woman writes book with her doctor
Pittsburgh Post-Gazette
When Susan Evans discovered her foot was swollen in December 2011, ovarian cancer never crossed her mind. “I thought it was sprained — I couldn’t figure out what I did to it,” the retired English teacher said. Now in remission from ovarian cancer, she wrote the book "Don't Write the Obituary Yet" with Thomas C. Krivak, MD. The two, along with her husband George, also formed the Evans-Krivak Gynecological Cancer Research Fund, with all of the profits and proceeds from the book going toward the fund.
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Women's Cancer News
Colby Horton, Vice President of Publishing, 469.420.2601
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