NOVATO, Calif., May 2 /PRNewswire/ -- Diamics, Inc., a privately held company developing products for cancer screening and diagnostics, today announced that it has begun high volume manufacture of its CerCol(TM) cervical sample collector. The initial GMP qualification run passed inspection and met product specifications. This allows production to commence so that Diamics can recognize revenue from its recently signed $22 million contract with the Bejing Jingmin Hospital Group.
Diamics’ representatives in China have moved forward with the CerCol registration. The hospital group has agreed to purchase the CerCol collectors and use them within their own facility as well as sell them to their affiliates to support the country’s focus on improving women’s health care.
“We are very pleased to initiate production in China of the CerCol collector and are delighted that the GMP qualification lot met product specifications,” said Christine Meda, President and COO, Diamics. “We are confident that the near-term and widespread use of the CerCol collector will prove to be a real advance for women’s health care not only in China, but as we introduce it into other markets. Evaluations for expanded aspects of the collector system are ongoing with laboratories and centers in the US. We have initiated discussions with cervical equipment manufacturers and distributors on the possible resale of the CerCol as part of their own-produced systems as well,” said Ms. Meda.
The use of the CerCol collectors and the accompanying Pap-Map(TM) technique is the first step in an agreement that binds the hospital group to purchase at least 1 million tests per year. Once Diamics’ C-Map System, a molecular based primary and adjunctive screening system, is approved by the SFDA in China, the CerCol, which is part of the C-Map system, will automatically be included in the contract.
About the CerCol Collector:
On March 21, Diamics announced 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. The new device demonstrated > 98% sample adequacy in multi-center clinical trials and offered patients greater comfort over conventional collector devices.
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.
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Diamics Inc.
CONTACT: Christine Meda, President, COO of Diamics, +1-415-883-0414,cmeda@diamics.com; or Jennifer Larson for Diamics, +1-415-409-2729,jlarson@labfive.com
Web site: http://www.diamics.com//
