Pathway Diagnostics Expands Biomarker Portfolio to Include Signatures for Chronic Obstructive Pulmonary Disease and Inflammatory Bowel Disorder.

MALIBU, Calif. -- Pathway Diagnostics Corporation(TM), a full-service biomarker development company, today announced that it expanded its biomarker intellectual property portfolio, allowing the company and its partners to use protein signatures to develop in vitro diagnostic tests and laboratory services for chronic obstructive pulmonary disease (COPD) and inflammatory bowel disorder (IBD).

"We continue to broaden our biomarker portfolio, focusing specifically on acquiring cutting-edge biomarkers in disease areas like COPD and IBD where a clear need exists for conclusive, reliable, and less-invasive testing," stated Walter M. Narajowski, president and chief executive officer of Pathway Diagnostics Corporation.

"By applying our expertise to validate and optimize these patent-protected protein signatures, they can be used for the diagnosis, prognosis, and characterization of COPD and IBD to implement the best patient care possible," said Meeta Patnaik, MD, Chief Science and Technology Officer for Pathway Diagnostics Corporation. "In addition, these signatures may be useful to stratify patients, to asses a patient's response to treatment, and to develop novel drug targets."

About Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading cause of death in the United States according to the National Heart, Lung, and Blood Institute. In 2001, 12.1 million adults were diagnosed with COPD, a progressive disease affecting the airways, causing a general loss of lung function; however, over 24 million adults have evidence of impaired lung function, indicating that COPD is drastically under diagnosed. The term COPD includes chronic bronchitis, emphysema, or a combination of these diseases. There is no cure for COPD, and treatments are generally supportive rather than therapeutic; however, there are several very promising therapeutic candidates that are in various stages of development by major pharmaceutical and biotech companies globally that employ such protein signatures for research purposes in stratifying patients. The total 2002 cost for COPD in the United States is estimated to be $32.1 billion.

About Inflammatory Bowel Disease 

Inflammatory bowel disease (IBD) is an inflammatory disease of the bowels and typically presents as a lifelong condition that features relapsing inflammation of the gastrointestinal tract. IBD is comprised of two forms, Crohn's disease and ulcerative colitis, and is typically diagnosed prior to the age of 30. IBD is a chronic condition, with acute disease flare-ups interspersed with periods of remission. The Crohn's and Colitis Foundation of America estimates that up to 1 million Americans suffer from IBD, and that IBD diagnoses lead to 100,000 hospitalizations, 700,000 physician office visits, and 119,000 people receiving disability, causing up to $1 billion in missed work days each year.

Current diagnostic tests include blood count, colonoscopy, and barium enema. Because IBD is a chronic condition, and often patients need daily medication over extended periods of time, diagnostic tests are repeated frequently to determine the scope and severity of the disease. Several diagnostic tests are normally completed and studied by a gastroenterologist before a diagnosis of IBD is made. The "gold standard" for diagnosis of IBD is considered the colonoscopy. Recently, new serologic tests have become available to aid in the diagnosis of IBD and differentiate between CD and UC, though the current markers are not sensitive enough to be used as screening tests for IBD.

About Pathway Diagnostics Corporation

Pathway Diagnostics is a biomarker development company focused on the novel application of patent-protected biomarkers to address unmet medical needs and improve patient management. The company combines unique expertise in biomarker development and application across multiple disease disciplines with a broad range of advanced technology platforms, a fully licensed laboratory for clinical trials, and extensive industry relationships for early access to intellectual property. Pathway's expertise in the identification, optimization, and validation of biomarker assays for all phases of drug development and clinical diagnostic applications makes them a valuable partner for pharmaceutical and biotechnology companies as well as clinical diagnostic test providers.