Proprietary CerCol Collector Addresses Limitations of Traditional Cervical

Sample Collectors

    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.
 
 

SOURCE Diamics