Pancreatica News Abstracts Archive - Fujirebio Diagnostics CA19-9 RIA Test for Pancreatic Cancer Receives FDA Clearance for US Marketing

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Fujirebio Diagnostics CA19-9 RIA Test for Pancreatic Cancer Receives FDA Clearance for US Marketing

Cortlandt Manor, New York, May 16, 2002

Polymedco, Inc. is pleased to announce the FDA marketing clearance for the Fujirebio Diagnostics, Inc. CA19-9(TM) Radioimmunoassay for monitoring of disease status in pancreatic cancer patients. Fujirebio Diagnostics, Inc. (FDI), a leading oncology diagnostics company, has partnered with Polymedco, Inc. to provide the highest standard of diagnostic tools and services to the oncology medical community.

The CA19-9 RIA is a simple laboratory test for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancer of the pancreas. This test enables physicians to evaluate and monitor the effectiveness of treatment and is the first blood test cleared for use in pancreatic cancer.

An in-vitro tumor marker, such as CA 19-9, can enable a physician to evaluate whether there is a need for immediate, additional imaging tests and more aggressive treatment because the disease is progressing, or whether the disease has stabilized and the current therapy should be continued. A decrease in CA 19-9 assay values correlates with a positive response to therapy. An increase in CA 19-9 values may indicate progressive disease and thus aid the physician in assessing treatment regimens.

Polymedco has distributed diagnostic test kits for over 21 years and has been involved with clinical studies, regulatory clearance and distribution of tumor marker products for over 10 years. Andrew Cervasio, Polymedco's President, stated, "This new FDA clearance will provide the physicians and laboratories with an important clinical tool supported by 2 decades of clinical studies. Polymedco and FDI will strive to promote greater awareness of the benefit of this assay which will ultimately provide effective monitoring for better cancer patient management".

Polymedco, Inc. will exclusively distribute the CA19-9 RIA Assay from their Cortlandt Manor, New York facility. The company will continue to provide front-line technical and customer service support as well as offer a wide range of ancillary products and equipment to facilitate efficient and accurate testing capability to the laboratories. Polymedco will continue to distribute the complete line of FDI tumor markers, as well as the Polymedco bladder tumor antigen tests.

Polymedco can be contacted by phone at 800-431-2123 or fax at 914-739-5890. http://www.polymedco.com .

CA 19-9 is a Registered Trademark of Fujirebio Diagnostics, Inc.

Press Release
SOURCE: Polymedco, Inc.

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	Pancreas Cancer News and Archives
		For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer
	Fujirebio Diagnostics CA19-9 RIA Test for Pancreatic Cancer Receives FDA Clearance for US Marketing Cortlandt Manor, New York, May 16, 2002 Polymedco, Inc. is pleased to announce the FDA marketing clearance for the Fujirebio Diagnostics, Inc. CA19-9(TM) Radioimmunoassay for monitoring of disease status in pancreatic cancer patients. Fujirebio Diagnostics, Inc. (FDI), a leading oncology diagnostics company, has partnered with Polymedco, Inc. to provide the highest standard of diagnostic tools and services to the oncology medical community. The CA19-9 RIA is a simple laboratory test for the serial measurement of CA 19-9 to aid in the management of patients diagnosed with cancer of the pancreas. This test enables physicians to evaluate and monitor the effectiveness of treatment and is the first blood test cleared for use in pancreatic cancer. An in-vitro tumor marker, such as CA 19-9, can enable a physician to evaluate whether there is a need for immediate, additional imaging tests and more aggressive treatment because the disease is progressing, or whether the disease has stabilized and the current therapy should be continued. A decrease in CA 19-9 assay values correlates with a positive response to therapy. An increase in CA 19-9 values may indicate progressive disease and thus aid the physician in assessing treatment regimens. Polymedco has distributed diagnostic test kits for over 21 years and has been involved with clinical studies, regulatory clearance and distribution of tumor marker products for over 10 years. Andrew Cervasio, Polymedco's President, stated, "This new FDA clearance will provide the physicians and laboratories with an important clinical tool supported by 2 decades of clinical studies. Polymedco and FDI will strive to promote greater awareness of the benefit of this assay which will ultimately provide effective monitoring for better cancer patient management". Polymedco, Inc. will exclusively distribute the CA19-9 RIA Assay from their Cortlandt Manor, New York facility. The company will continue to provide front-line technical and customer service support as well as offer a wide range of ancillary products and equipment to facilitate efficient and accurate testing capability to the laboratories. Polymedco will continue to distribute the complete line of FDI tumor markers, as well as the Polymedco bladder tumor antigen tests. Polymedco can be contacted by phone at 800-431-2123 or fax at 914-739-5890. http://www.polymedco.com . CA 19-9 is a Registered Trademark of Fujirebio Diagnostics, Inc. Press Release SOURCE: Polymedco, Inc.

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