Diamics Submits 510k to FDA for Unique Cervical Collection Device.
NOVATO, Calif. -- Diamics, Inc., a San Francisco Bay-area, medical device and diagnostics company, today announced it has submitted a 510(k) premarket notification application to the FDA for its proprietary CerCol cervical collection device. The CerCol device is designed to improve screening for cervical cancer and greater comfort to the patient.
The CerCol collector is designed to capture a mirror image sample from 360 degrees of the endocervical canal, the ectocervical area and the transformation zone of the cervix with a single device. When the CerCol is placed in the cervix, its reusable handle allows for the rotation of the disposable collector tip.
The CerCol has been developed to be used both as part of a standard, liquid-based Pap test and as a component of Diamics' C-Map cervical cancer screening system. When used in the C-Map system, the collector captures a unique cervical sample which is transferred to a slide, exposed to a proprietary antibody assay and read by a fully-automated scanner. The scanner then generates a representative map of the cervix and shows the general location of any precancerous lesions.
The 510(k) application used data from a clinical trial that 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. The collector sample in the clinical trial supporting the 510(k) application was put into a liquid-based preservative for Pap analysis, More than 250 women undergoing an annual gynecological exam participated in the study at multiple sites.
FDA 510(k) applications serve as a screening mechanism to allow for marketing of medical devices with a reasonable assurance of safety and effectiveness.
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.