FDA Ovarian Cancer Screening Test Warning
The US Food and Drug Administration FDA issued a warning about the risks associated with testing marketed as ovarian cancer screenings and the delay in preventive treatments for women who are at an increased risk for developing ovarian cancer.
Though research and studies have extensively looked at screenings for the detection of ovarian cancer, no ovarian cancer screenings have been found to be sensitive enough to be reliable without high numbers of false results. False or inaccurate results include: women who receive a false-positive, or results that suggest ovarian cancer is present when it is not and therefore undergo unnecessary medical treatment or surgery. Alternately, women may receive results indicating a false-negative, meaning no ovarian cancer was found when in fact the cancer is present. This faulty result often results in delayed treatment.
The FDA is warning women and their doctors not to be misled by the claims of these screenings and to not make treatment decisions based on claims or even results of these tests. Currently, there is no safe, effective screening for ovarian cancer.
Contract Laboratory has helped facilitate many cancer and medical device testings such as:
- iosafety Level BSL-2 Laboratory needed for conducting research on oncolytic viruses based on HSV1, Herpes Simplex Virus. We are looking for services for titrating how much HSV1 virus is present in our samples (e.g. plaque assays) and/or assays measuring cytopathic affect of virus in samples (CPE). We can provide cell lines for these assays if needed. If possible, we would also like to provide cancer cell lines to use for testing after titration is done in a more common cell line (e.g. vero cells).
- Preclinical Contract Research Organization CRO needed for preclinical trial for specialized health supplement product. The objective is to measure the impact of product on the blood lactate level of ill test subjects, possibly rats. The type of illness can vary but we are especially interested in cancer
- Ireland University Researcher needed for preclinical studies efficacy and cytotoxicity testing on Platinum(IV) drug anti-cancer agents. I am already working on identifying the effectiveness of these drugs e cytotoxicity studies on different cell lines
- Toxicology Laboratory needed for toxicology testing of agricultural fungicide: Toxicological data on the technical grade material (Animal data) 1. Acute oral toxicity 2. Acute dermal toxicity 3. Inhalation toxicity 4. Skin irritation 5. Eye irritation 6. Skin or dermal sensitization 7. Sub-acute studies 8. Teratology/reproductive studies 9. Mutagenicity studies 10. Toxicity on nervous system studies 11. Metabolism data required to determine of absorption, excretion, distribution, accumulation and transformation in the animal body and their metabolites. 12. Tumor and cancer induction (if any) Toxicological data on the formulated/finished product (Animal data) 1. Acute oral toxicity 2. Acute dermal toxicity 3. Inhalation toxicity 4. Skin irritation 5. Eye irritation 6. Skin or dermal sensitization 7. Precaution for usage and storage 8. Diagnosis of poisoning, specific signs of poisoning, clinical teste 9. First aid measure 10. Medical treatment Information on environmental toxicity e.g. fish toxicity (LC50)
- Germany or Europe Contract Research Organization needed for preclinical study to Test of novel immune stimulatory compounds in a mouse cancer model. Compounds are provided, mouse lab needed.
If you need cancer, oncology, or other medical device research or testing, call us at 1-855-377-6821 or submit a Laboratory Test Request.
Read the full US Food and Drug Administration FDA News Release
Originally posted 2016-09-08 17:55:50.