Diamics Completes Clinical Trial and Appoints CRO for FDA Submission.NOVATO, Calif. -- Diamics, Inc., a San Francisco Bay-area, medical device and diagnostics company, today announced completion of its clinical trial for the company's proprietary cervical collection device which is designed to improve screening for cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. . Diamics will use the trial results, comprising more than 250 patients, as part of its 510k submission to the Food and Drug Administration. In the clinical trial, the collector sample was put into a liquid-based preservative for Pap analysis. The collector is designed to capture 360 degrees of the endocervical canal, the ectocervical area and the transformation zone of the cervix cervix /cer·vix/ (ser´viks) pl. cer´vices [L.] 1. neck. 2. the front portion of the neck. 3. cervix uteri. at one time. The CerCol collector has been developed to be used both as part of a standard, liquid-based Pap test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. and as a component of Diamics' C-Map cervical cancer screening system. When used in the C-Map system, the collector captures a fractional histological sample which is transferred to a slide, exposed to a proprietary antibody assay and read by an automated scanner. The scanner then generates a map of the cervix showing the location of any precancerous precancerous /pre·can·cer·ous/ (-kan´ser-us) pertaining to a pathologic process that tends to become malignant. pre·can·cer·ous adj. lesions. The clinical trial measured cellularity, (whether a sufficient number of cells was collected), adequacy (the presence of cells representative of the endocervix and transformation zone -- the two areas of the cervix where cervical cancer typically starts), reporting according to the Bethesda Classification System, and patient comfort. More than 250 women undergoing an annual gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. exam participated in the study at multiple sites. Diamics also announced it has employed Cato Research, an internationally recognized clinical research organization (CRO), to submit the company's 510k on the CerCol Collector. The 510k will be submitted within the next two weeks. Cato also will be responsible for monitoring the international C-Map clinical trial and the submission of the company's PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy to the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. . No fewer than five US and international centers will be involved in this trial. "The unique properties of the CerCol provide a single collection device that captures a sample from all regions of the cervix while providing patients with more comfort and less trauma," said Peter Gombrich, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , Diamics, Inc. About Diamics, Inc. Diamics Inc. is a privately owned medical device and diagnostics company located in Novato, California. The company is committed to developing, manufacturing, and marketing cost-effective, molecular-based cancer screening and diagnostic systems that will increase long-term survival rates through early detection. Diamics has a mature management team with an extensive track record in the medical device and diagnostics industries. The company's goals are to help medical personnel worldwide improve lives and to create value for investors, employees and all who use and benefit from its proprietary technology. Please visit www.diamics.com. |
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