A Diagnostics & Imaging Week

Abbott (Abbott Park, Illinois) and OraSure Technologies (Bethlehem, Pennsylvania) have entered into an agreement for the distribution of OraSure Technologies' OraQuick Advance rapid antibody test for the detection of antibodies to the Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2).

Under the terms of the distribution agreement, Abbott was appointed as exclusive distributor of the OraQuick Advance HIV-1/2 test for hospitals and as a non-exclusive distributor to physician offices in the U.S.

"We believe this agreement will enable us to capitalize on the growing demand for our new OraQuick Advance test and help achieve our goal of making rapid HIV testing available to all who need it," said Douglas Michels, president and CEO of OraSure Technologies. "With the sales and marketing teams from OraSure and Abbott working together, we will expand the reach of this product in the U.S."

Providing results in as little as 20 minutes, Advance is the only rapid, point-of-care test for the detection of antibodies to both HIV-1 and HIV-2 approved by the FDA for use on oral fluid, fingerstick or venipuncture whole blood, and plasma specimens, OraSure said. The test is also CLIA (Clinical Laboratory Improvements Amendments Act of 1988)-waived for all specimen types except plasma. OraSure commercially launched the Advance test last October.

Under the agreement, OraSure will sell the Advance to physicians' offices on a non-exclusive basis and exclusively to the Centers for Disease Control and Prevention (Atlanta), the Substance Abuse and Mental Health Administration, community-based organizations, state and county public health departments, correctional and criminal justice facilities, clinics and other public health customers.

Other terms of the agreement were not disclosed.

Gen-Probe (San Diego) said that it has signed a supply and purchase agreement with F. Hoffmann-La Roche Ltd. (Basel, Switzerland) and its affiliate, Roche Molecular Systems, under which Gen-Probe will purchase products for use in molecular diagnostic assays for human papillomavirus (HPV).

Under the agreement, Roche will manufacture DNA probes for HPV, which Gen-Probe will purchase at agreed-upon transfer prices. Gen-Probe also has agreed to pay initial manufacturing fees in two installments.

Gen-Probe plans to use HPV probes supplied by Roche in its Aptima format HPV test kits to detect high-risk subtypes of HPV.

"Developing an HPV test is an important part of Gen-Probe's long-term strategy to enter new markets where there are important medical needs and attractive commercial opportunities," said Henry Nordhoff, the company's chairman, president and CEO. "A highly sensitive and specific HPV assay will fit perfectly with our strong STD franchise, and be an ideal high-volume test to expand the menu of our fully automated, high-throughput Tigris system."

HPV is a group of viruses that includes more than 100 different subtypes. Some types infect the skin and cause warts, whereas others are sexually transmitted.

Ciphergen Diagnostics (Fremont, California), a division of Ciphergen Biosystems, said that it has signed a research and license agreement with the University of Texas M.D. Anderson Cancer Center (Houston) to use Ciphergen's ProteinChip System and associated bioinformatics suites to further their ongoing research in ovarian cancer. M. D. Anderson is a major referral center for patients with ovarian cancer and is a National Cancer Institute-designated Comprehensive Cancer Center.

"This agreement allows us to further our collaborative efforts with leading ovarian cancer researchers to refine biomarkers to be used in an ovarian cancer diagnostic test," said Gail Page, president of Ciphergen Diagnostics. "Last year's landmark publication in Cancer Research was the first in what we hope will be a series of publications describing the utility of these biomarkers. Dr. Bast, a world authority on ovarian cancer, was a key contributor to that publication and we are very pleased that he will continue his work with Ciphergen."

Under the terms of the agreement, Ciphergen will analyze clinical samples provided by M. D. Anderson for ovarian cancer using its Deep Proteome and Pattern Track suite of proteomics tools designed for biomarker discovery and development of assays using the ProteinChip System.

Ciphergen has exclusive rights to license discoveries made during the course of this collaboration. This work will address multiple clinical questions, including validation of markers described in the Cancer Research article, as well as discovery of markers that distinguish ovarian cancer from other gynecologic masses and prediction of treatment response. Research work plans and licensing rights beyond ovarian cancer can be added to the basic research and license agreement by mutual consent of Ciphergen and M.D. Anderson Cancer Center.

BioVeris (Gaithersburg, Maryland) said it completed an agreement with the National Research Council of Canada (NRC) for a license to patent rights to candidates for a group B streptococcus (GBS) Type II and Type V vaccine and a group B meningococcus (GBM) vaccine.

Under the agreement, the company acquired worldwide, exclusive rights to commercialize products for possible use in the prevention, diagnosis and treatment of disease caused by GBS, a leading cause of sepsis, pneumonia, and meningitis among newborns. The company received similar worldwide rights, with the exclusion of Canada, to NRC's GBM vaccine technologies for the prevention of meningococcal B meningitis and sepsis.

Under the license agreement, the company is required to pay a royalty on product sales, including a minimum $10,000 annual royalty that commences immediately.

About 25% of pregnant women are carriers for GBS and the newborn infection is predominantly transmitted from mother to baby during labor.

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