NOVATO, Calif., March 21 /PRNewswire/ -- Diamics, a privately-held company developing products for cancer screening and diagnostics, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its proprietary CerCol Cervical Sample Collection System. The CerCol Cervical Collector is intended for the collection of cervical cytology material and its transfer for Pap analysis.
Cancer of the cervix is the second most commonly diagnosed cancer in women worldwide. Approximately 500,000 new cases are diagnosed each year, 80% of which occur in developing countries. It is estimated that of the more than 2.5 billion females worldwide who are eligible for cervical cancer testing, only approximately 6%, or 160 million, are screened routinely.
The CerCol collector is distinct from the traditional spatula and broom scrape-collection technique in that it captures both cellular and fractional histological material from the entire cervix with a single device, yet maintains the spatial orientation of where the sample was collected. The study was conducted in collaboration with several Planned Parenthood Mar Monte, California clinics and clinics in Marin County, California. In the study, the new device demonstrated > 98% sample adequacy as compared to medical literature which reports adequacy rates as low as 76% with broom-type cervical collectors. In addition, the CerCol collector offers patients greater comfort.
The CerCol collector is comprised of a soft, anatomically-contoured collection tip. The collector with its reusable handle expands the tip to conform to the cervix, and assures 360 degree contact. In contrast to traditional techniques, the CerCol collector allows for consistent, operator- independent sampling which collects from endocervical, ectocervical and its transformation zone. Following collection, the collector can be placed in a liquid preservative or transfer device, currently in validation, which creates a “touch-prep” impression onto a slide for normal Pap staining. This Pap- Map(TM) technique maintains the original spatial orientation of the cervical sample thereby supporting localization of identified lesions in both initial diagnosis and follow-up treatments.
Issues with the Pap test, including false negative results, can be attributed to the failure of the current broom and spatula collection methods to adequately collect abnormal cells. In response to this recognized problem, over-interpretation of the collected sample has led to an increase in the number of false positives as noted in the medical literature.
Dr. Richard Fischer, a gynecologist who participated in the study said, “The CerCol collector is an innovative device which demonstrated > 98% sampling adequacy. Its potential added ability to map the area where abnormal cells are found may improve the accuracy of subsequent cervical cancer testing.”
“Adequate and proper cervical sample collection plays a vital role in the quality and value of test results. Until now, there have been no significant advancements in sample collection since Pap screening was first introduced more than 50 years ago,” said Peter Gombrich, Chairman and CEO of Diamics. “In addition to the immediate benefits to current Pap screening, the CerCol is also a key component of our C-Map molecular-based cervical cancer screening system now in clinical testing.
About Diamics, Inc.
Diamics Inc. is a privately owned medical device and diagnostics company located in the San Francisco Bay Area. The company is committed to developing, manufacturing, and marketing cost effective, molecular-based cancer screening and diagnostic systems that will increase long-term cancer survival rates through early detection. Diamics’ management team has an extensive track record of success in the medical device and diagnostics industries. The company’s mission is twofold: to help medical personnel worldwide improve the lives of the people they treat and to generate a return on investment for its shareholders. For more information, please visit www.diamics.com.
Diamics
CONTACT: Christine Meda, President, COO of Diamics, +1-415-883-0414, orcmeda@diamics.com; or Jennifer Larson, +1-415-409-2729, orjlarson@labfive.com, for Diamics
Web site: http://www.diamics.com//
