Biomoda Selects RCRI to Be CRO for Pivotal Trial of CyPath(R) Lung Cancer Diagnostic
Dec. 1, 2010 (Business Wire) -- Cancer diagnostics company Biomoda, Inc. (OTCBB: BMOD) (www.biomoda.com) has selected RCRI, Inc. to be the Contract Research Organization (CRO) for the upcoming pivotal clinical trial of the CyPath® diagnostic for early detection of lung cancer.
“RCRI’s strategic approach to clinical trial design and management will provide additional expertise to the pivotal trial of our CyPath® diagnostic, ” Biomoda President John Cousins said. “Conducting clinical trials is increasingly more complex, and RCRI is the perfect partner to help us move our CyPath® product toward FDA approval.”
“We are pleased to be collaborating on this project with Biomoda,” said Steve Norsted, PhD, MPH, President and CEO of RCRI. “The CyPath® technology is the ideal complement to our oncology and medical device expertise and is an innovative product that has significant potential for improving patient outcomes.”
Biomoda’s CyPath® labeling solution for the early detection of cancers binds to cancer cells and fluoresces under specific frequencies of medium light. Biomoda is seeking Food and Drug Administration (FDA) approval of its cytology-based screening technology as a Class III medical device. Pending FDA approval, CyPath® is for investigational use only.
RCRI will support the CyPath® pivotal clinical trial by providing Biomoda with a comprehensive suite of clinical study services, including project management, site identification, recruitment, data management, statistical design and reimbursement strategy.
About Biomoda
Biomoda (www.biomoda.com) is a cancer diagnostics company focused on the development of accurate, inexpensive and noninvasive tests for the early detection of cancer. In addition to its first product for lung cancer, diagnostic assays for cervical, breast, colorectal, bladder, and oral cancers are targeted for development.
About RCRI
Founded in 1999, RCRI, Inc. (www.rcri-inc.com) has helped more than 400 medical device, IVD, and biologics companies worldwide translate their medical product plans into successful revenue-generating businesses. RCRI is ISO 9001: 2008 certified to provide expertise in regulatory affairs, clinical trial design and management, database development, reimbursement strategy, health economics, quality systems and compliance, biostatistics and venture capital due diligence.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are based on estimates, projections, beliefs and assumptions of Biomoda management at the time of such statements and are not guarantees of future performance. Forward-looking statements involve risks and uncertainties in predicting future results and conditions. Actual results could differ materially from those projected in these forward-looking statements due to a variety of factors, which are described from time to time in the Company’s reports and registration statements filed with the Securities and Exchange Commission, including those under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the SEC on March 30, 2010. Forward-looking statements are made as of the date of this press release and are subject to change without notice.
Biomoda, Inc.
Julie Anne Overton, 505-577-0918
Source: Business Wire (December 1, 2010 - 9:20 AM EST)
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