A Medical Device Daily

SRI Surgical (Tampa, Florida) reported a multi-year exclusive agreement to distribute Owens & Minor's (O&M; Richmond, Virginia) Implant Tracking System to the tissue-banking industry.

Using barcode technology, Owens & Minor's Implant Tracking System is designed to enable clinicians to efficiently track bone and tissue implants, monitor expiration dates on implants, and rapidly identify implant recipients in case of recalls.

SRI Surgical will market the Implant Tracking System under the ReadyTrack Powered by OMSolutions name and will include the IT application as part of SRI's comprehensive ReadyCase for Donor Services solution.

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.“

In other agreements:

• Welch Allyn (Skaneateles Falls, New York) reported that it has partnered with Wellogic (Cambridge, Mass-achusetts), a healthcare software company, to develop software solutions designed to provide enhanced clinical efficiencies by linking Welch Allyn's digital medical devices to clinical information systems through a data management solution that initially helps clinicians monitor and analyze vital signs data at the point of care.

“We are pleased to team up with Wellogic in developing a truly unique solution that will help caregivers in front-line hospital settings more efficiently care for their patients by providing timely, real-time access to accurate and reliable patient-specific data captured by our devices,“ said Welch Allyn Executive Vice President Douglas Linquest. “Together, we'll be able to both enhance the efficiency and safety with which care is delivered.“

• HemoCue (Lake Forest, California) reported signing a distribution agreement with Cardinal Health (Dublin, Ohio), calling the pact “an important step for HemoCue in expanding [our] distribution network in both the physician office and hospital markets.“

The products that Cardinal will carry include Hemo-Cue's data management, hemoglobin, glucose and urine albumin systems.

HemoCue is a provider of products for point-of-care testing. In hospital settings, the Hb 201 DM System is most suitable for emergency room and operating room for fast hemoglobin results. The Glucose 201 DM System is most suitable for critical care settings and tight glycemic control programs, the company said.

HemoCue is owned by EQT, a European private equity group.

• Biosite (San Diego) and Five Prime Therapeutics (Mission Bay, California) have entered into a collaboration for the evaluation of disease targets for potential commercialization of diagnostic and therapeutic products.

FivePrime will provide Biosite access to selected functional disease targets for use in developing diagnostics, and Biosite will provide FivePrime with Omniclonal antibodies for selected targets. Biosite's antibody development process generates diverse libraries of Omniclonal antibodies with high affinity and low cross-reactivity.

FivePrime's discovery platform enables the rapid screening of the complete set of secreted proteins and their receptors in medically relevant, cell-based assays to identify new biotherapeutics. FivePrime is applying its high throughput biologics discovery system first in the areas of oncology, diabetes, immunology and regenerative medicine.

Biosite commercializes proteomics discoveries for the advancement of medical diagnosis.

• Magla Products (Morristown, New Jersey), a maker of home, garden and work gloves and cleaning products, has signed a licensing agreement with the American Red Cross (Washington) to market a broad line of disposable medical exam gloves under the American Red Cross brand name.

The initial product line will consist of disposable latex, powder-free latex, Nyplex, and Nitrile gloves. Each type of glove will be available in a 10-count bag as well as both 40-count and 80-count dispenser boxes.