A Diagnostics & Imaging Week

Animas (West Chester, Pennsylvania) reported completing its purchase of certain assets from Cygnus (Redwood City, California) for $10 million in cash, following approval of the deal by Cygnus' stockholders. The purchase was first disclosed late last year.

In the purchase, Animas acquired substantially all of Cygnus' intellectual property rights; product development and production equipment; regulatory package; supplier, manufacturing and license agreements; and inventory. Animas also assumed ownership of more than 235 U.S. and foreign patents in the fields of continuous glucose sensing, electrochemical sensors and extraction of interstitial fluid by reverse electro-iontophoresis.

Animas noted it did not assume any of Cygnus' liabilities other than "customary obligations under assumed contracts."

Cygnus manufactured the GlucoWatch Biographer, "the first and still only commercially available continuous glucose monitor that provides the patient with real-time blood glucose readings and alarms for hypoglycemia and hyperglycemia," Animas said in a statement. The FDA approved the product in 2001 as an adjunct to traditional fingerstick home blood glucose testing.

The GlucoWatch Biographer uses reverse electro-iontophoresis to extract glucose molecules, a process that is less invasive than other approaches to continuous glucose monitoring presently under development.

"With the consummation of the purchase of certain assets from Cygnus, Animas has broadened its technology base and intellectual property portfolio considerably in the field of glucose sensing," said Kathy Crothall, president and CEO of Animas. "Cygnus' electrochemical sensor technology is highly developed, demonstrated by its extraordinarily high sensitivity and the number of sensors produced. We applaud the fine work done by Cygnus scientists and engineers over the past decade to develop this technology."

She added: "Like any first-generation technology, the product suffers from some significant shortcomings. We believe many of these issues can be addressed and are evaluating the commercial feasibility of these improvements."

Serologicals (Atlanta) reported that Upstate Group (Charlottesville, Virginia), its wholly owned subsidiary, has obtained the rights from the University of California to sell the anti-ZAP-70 monoclonal antibody for diagnostic use. Terms of the sales deal were not disclosed.

Upstate said it anticipates significant growth from anti-ZAP-70 monoclonal antibody, including development of ZAP-70 diagnostic kits, ZAP-70 as a biomarker and the ability to offer GMP-approved ZAP-70 quantities.

Studies show that the levels of expression of the ZAP-70 protein strongly predict the aggressiveness of chronic lymphocytic leukemia.

One such study, in the May 2003 issue of the New England Journal of Medicine, cited use of Upstate's anti-ZAP-70, clone 2F3.2, monoclonal antibody. Scientists used anti-ZAP-70 in immunohistochemistry, flow cytometry and Western blot analysis of samples from chronic lymphocytic leukemia patients.

"Anti-ZAP-70 formerly was only available for research use," said Ian Ratcliffe, president of Upstate. "Since the publication of the New England Journal of Medicine study, we have had multiple customer inquiries about its diagnostic or therapeutic use in humans or animals. The recently obtained rights will allow us to work more closely with diagnostic companies active in cell signaling."

Chronic lymphocytic leukemia is a cancer involving the lymph system. According to the National Cancer Institute (Bethesda, Maryland), the disease affects about 8,200 Americans annually, most often in the middle-aged and elderly, with about 5,000 dying of it each year in the U.S.

Upstate is a provider of cell signaling products and services to the life sciences, such as drug screening services, enzymes, state-specific antibodies, siRNA kits and multiplex assays. Besides its Charlottesville headquarters, Upstate has locations in Lake Placid, New York, and Dundee, Scotland.