A Diagnostics & Imaging Week

Signet Laboratories (Dedham, Massachusetts) reported signing an agreement with AsymmetRx (Connecticut), providing exclusive distribution of its 510(k)-cleared Prostate-63 (IVD) Prostate Cancer Diagnostic Test Kit using p63. Signet said the kit is the only FDA-cleared prostate cancer diagnostic test kit, the first in a series of kits that uses p63 to diagnose prostate cancer.

AsymmetRx holds the exclusive, worldwide license under Harvard Medical School (Boston) patent filings (including U.S. patent No. 6,946,256) for the use of p63 antibodies to diagnose prostate and other cancers, and recently received FDA 510(k) clearance for the use of p63 as an in vitro diagnostic test to aid pathologists in diagnosing prostate cancer.

The p63 protein is a member of the p53 family, which also includes p73, and is expressed in the nucleus of basal cells in the epithelium. Markers of basal cells are useful in diagnostic pathology particularly when examining difficult prostate biopsies. Because p63 is localized to the nucleus of cells, it can offer distinct advantages over cytoplasmic labeling, according to AsymmetRx.

The p63 gene was discovered in the Harvard lab of AsymmetRx founder Dr. Frank McKeon, and the p63 prostate cancer diagnostic test was invented by a collaboration of labs at Harvard and Harvard-affiliated hospitals.

Maria McKeon, AsymmetRx president and CEO, said that the p63-based test "adds a significant advantage to making a correct diagnosis. This kit ushers in the only FDA-cleared prostate cancer test which aids pathologists in the differential diagnosis of prostate cancer in conjunction with morphological findings."

JMAR Technologies (San Diego), a developer of advanced laser technology, has finalized a licensing agreement with Colorado State University Research Foundation as agent for Colorado State University (Fort Collins, California) for the use of its discharge pumped soft X-ray laser, developed under the auspices of the National Science Foundation's (Arlington, Virginia) Engineering Research Center for Extreme Ultraviolet Science and Technology. The laser produces high-intensity soft X-ray radiation at a wavelength shorter than any other laser on the market today and complements JMAR's Laser Produced Plasma X-ray source that produces still-shorter wavelengths.

In other agreements:

• CytoCore (Chicago) and University Hospitals of Cleveland (UHC) and Case Western Reserve University (Cleveland) reported the signing of a joint research and development program between CytoCore and Univer-sity Hospitals of Cleveland and the university. CytoCore, a bio-molecular cancer screening company, is working to bring forward biomolecular products to provide better cervical cancer solutions, the company said.

From this partnership, CytoCore will be expanding its research capability and product portfolio with several announcements. These new developments are expected to accelerate the successful testing and development of the company's core products, while also significantly expanding its product offerings.

CytoCore said it expects to grow from a cyto-screening company to a cyto-diagnostic company. It said it expects to offer a unique therapeutic device that fills the vacuum in today's cervical cancer screening and treatment menu.

• Medwave (Danvers, Massachusetts), a developer of sensor-based, non-invasive blood pressure measuring solutions, on the heels of the launch of its new Primo brand, said that it has retained the services of ASI Marketing (Minn-eapolis), a marketing communications firm. Medwave said the intent is to fortify brand in the consciousness of target audiences, "while assuring a highly publicized launch of the Primo monitoring system."

The Primo Non-Invasive Blood Pressure Monitoring System is designed to be sold into the point-of-care blood pressure monitoring market.

ASI – which has worked with Blue Cross/Blue Shield, Bristol-Myers-Squibb, Guidant, Medtronic, Merck, Miracle-Ear and Pfizer – will handle advertising, public and media relations, copywriting and general strategic marketing counsel for Medwave.

Medwave manufactures the InVasotrac APM205A NIBP Monitor, the Vasotrac APM205A Model DS and the MJ23 OEM Module, non-invasive blood pressure monitors. Its Legato OEM Developers Kit is designed to introduce the Vasotrac technology to OEM designers. Medwave reports having agreements with Nihon Kohden, Zoll Medical, Analogic and others.

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