A Medical Device Daily
Vermillion (Fremont, California) reported that it has agreed with Quest Diagnostics (Madison, New Jersey) to extend a strategic alliance agreement through October 2009. This extension will enable the companies to continue work on the development and commercialization of two tests, OVA1 and Vasclir.
The OVA1 test is intended to identify women with ovarian tumors that are at high risk of being malignant. Data from a 27-site, 511 subject prospective clinical trial were submitted to the FDA in June of this year in a 510(k) pre-market notification.
Vermillion's 510(k) pre-market notification submission is currently pending before the FDA. To date, the company and the agency have had several substantive discussions regarding the submission. Vermillion said it is "encouraged" by the constructive nature of these discussions and by the interactive review process with the FDA.
Vasclir is a test designed to help physicians identify those patients who are at high risk of developing peripheral artery disease. Vermillion is developing this test in collaboration with John Cooke at Stanford University (Stanford, California). Results from a 540-subject validation study were published recently in Vascular Medicine.
In other agreements and contracts news:
• Hill-Rom (Batesville, Indiana) reported a new agreement with Encompass Therapeutic Support Systems (Glendale, California) to provide its AccuMax Quantum VPC Support Systems for use with Hill-Rom bed frames.
"We are excited to move forward in our relationship with Encompass," said Mary Butler, executive director of marketing and strategy for global surfaces at Hill-Rom. "This agreement is part of our focus on developing key alliances with other leading companies in the healthcare area. We believe the agreement with Encompass will bring a valuable new choice to our customers as they look for the right solutions to meet the needs of their patients. Encompass offers a cost effective solution as well as proven clinical efficacy in this important product area."
Butler added that the new agreement should enable Hill-Rom to increase options for customers who may be looking to replace only part of a bed system. Under the agreement, Hill-Rom will be the exclusive provider of this non-powered surface product for use with Hill-Rom's signature TotalCare Therapy System and VersaCare Bed System.
• ACIST Medical Systems (Minneapolis) said it signed a distribution agreement for the StatSensor Creatinine Meter with Nova Biomedical (Waltham, Massachusetts). The agreement calls for the ACIST and Nova teams to co-exclusively market and distribute the StatSensor Creatinine Meter into the medical fields of radiology and cardiology, initially within North America. Within this new distribution structure, both ACIST and Nova will focus on providing its customer's with seamless continuity for the StatSensor solution from point of care deployment in imaging modalities where iodine and gadolinium derived intravenous contrast agents are administered, to platform management, and its connectivity into the clinical laboratory.
The StatSensor Creatinine measures a patients blood creatinine level and calculates their eGFR (estimated glomerular filtration rate) prior to contrast agent administration via a finger prick. Blood creatinine levels and eGFR are key clinical factors allowing the clinician to assess patient renal function and eligibility for IV contrast administration.
• Oridion Systems (Jerusalem) said it signed a three-year purchase agreement with Kaiser Foundation Health Plan (Needham, Massachusetts) for Oridion's capnography (Microstream) monitors and CO2 breath sampling consumables.
With this agreement, Oridion becomes Kaiser's sole supplier for Oridion's consumable products, thus providing savings for the entire Kaiser system of 30 hospitals and 400 other healthcare facilities.
• Guided Therapeutics (Norcross, Georgia) and Konica Minolta Opto (Tokyo) reported that they have extended an agreement to co-develop certain GT non-invasive technologies.
GT and KMOT expect to negotiate, and then sign, a definitive development agreement within approximately six months. A major focus of the agreement is expected to include jointly adapting GT's LightTouch non-invasive cervical cancer detection technology to lung and biliary cancer detection products.
• Aetna (Hartford, Connecticut) said that it has reached agreement with the Orlando Health (Orlando, Florida) physicians group on a three-year contract renewal. Under the new contract, Aetna for the first time will have a direct contract with South Seminole Behavioral Specialists, a behavioral health physicians group that serves Central Florida.
"Aetna is very pleased to offer its Central Florida members in-network access to behavioral health services," said Jim McCunney, Aetna's vice president of network development for Central Florida.
Aetna also recently renewed its hospital agreement with Orlando Health, a 1,780-bed system.