Medical Device Daily

Abbott (Abbott Park, Illinois) reported earlier this week that it has entered into a licensing agreement with Advanced Life Science Institute (ALSI; Saitama, Japan) for a peptide that Abbott said “may assist clinicians in diagnosing and monitoring small-cell lung cancer.”

There is currently no serum diagnostic test approved in the U.S. for the aggressive and deadly disease.

Additionally, Abbott provided a look-ahead at tests in its “pipeline” and laboratory instruments that are scheduled to be introduced to the market in 2006 and 2007.

“ProGRP has shown promise in preliminary studies as a test for lung cancer, which accounts for about 13% of the new lung cancer cases in the U.S. alone each year,” said William Brown, PhD, vice president, diagnostic assays and systems development for Abbott.

The terms of the agreement call for Abbott to obtain worldwide rights to commercialize products using ALSI's ProGNP material and technology. No other financial terms were disclosed.

An Abbott spokesperson said that there is no specific timeline for development of the lung cancer test, but it would be developed over the course of years.

“In Japan, scientific findings on ProGRP have already influenced how small-cell-lung cancer is diagnosed and managed by physicians. By partnering with Abbott, ALSI may be able to bring this tumor marker technology, and its potential to improve patient outcomes through earlier diagnosis, to a larger audience,” said Tetsuo Itoh, PhD, president and CEO, ALSI.

Current detection methods include chest X-ray, which has been shown to miss small nodules as well as to result in false positives according to a large National Cancer Institute (Bethesda, Maryland) study (Medical Device Daily, Dec. 29, 2005), and computed tomography (CT).

Abbott said that according to the American Cancer Society (Atlanta), lung cancer is the leading cause of cancer death in men and women. About six out of 10 people with lung cancer die within one year of being diagnosed with the disease; however, the chance of cure increases “substantially” if cancer is detected early.

In the media briefing on Tuesday, Brown said that Abbott is focusing on clinical assays that will improve patient outcomes in five areas: cardiac, cancer, renal, infectious disease and women's health. In cancer, Abbott expects to expand its product offerings for assays to help diagnose the most prevalent forms of cancer, such as breast cancer, colorectal and prostate cancer.

Brown also reported that Abbott has filed seven premarket approval applications since November, particularly in the area of hepatitis.

“Pending regulatory review, we expect to introduce a number of automated assays in the second half of 2006,” Brown said.

In other biomarkers, Abbott is developing assays over the long-term for acute coronary syndrome (ACS), as well as anti-CCP, which is a biomarker for diagnosing rheumatoid arthritis. Abbott also makes the monoclonal antibody drug, Humera, for rheumatoid arthritis.

Another marker that the company is working on is one for a test for Chagas disease, which would be used on Abbott's Prism system and demonstrating Abbott's “commitment to improving the safety of the blood supply.”

“Currently, there are no automated tests for Chagas,” Brown said, describing it as a “deadly parasitic infection that can be transmitted through transfusion” and that can result in “irreversible cardiac, gastrointestinal or neurological damage.”

In the area of women's health, Abbott is working on a test for preclampsia, a disease that Brown said “is responsible for over 76,000 deaths per year and is a very serious condition for both the mother and the child during pregnancy.”

Brown also discussed laboratory instruments that are either in development or that Abbott is preparing to launch. The company expects to launch in early 2007 a new laboratory system in its Architect family targeting the mid-volume segment of the laboratory market using the same “sample handling system.”

“Only for this analyzer . . . we're going to use the robotics to not only manage the sample, but also offer the ability to take reagents on and off the system,” Brown said, calling it a “significant new feature to the Architect family.”

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