A Medical Device Daily

Ciphergen Diagnostics, a division of Ciphergen Biosystems (both Fremont, California), reported renewal of its multi-year accord with the Johns Hopkins University School of Medicine (Baltimore) aimed at the discovery of protein biomarkers in the field of cancer. The focus of the collaboration over the last five years has been to discover and validate new diagnostic biomarkers that may improve cancer detection, classify types of disease and provide disease monitoring.

This collaboration led to the publication, in August 2004 in Cancer Research, of a study describing the use of Ciphergen's PatternTrack approach to discover three protein biomarkers as the basis for a potential assay to detect early stage ovarian cancer. The three biomarkers, when combined, were able to diagnose early stage (I/II) ovarian cancer with 74% sensitivity and 97% specificity.

Ciphergen will continue to provide financial support, technical assistance and access to advanced platforms through its Biomarker Discovery Center scientists. Johns Hopkins will continue to provide its resources, such as serum samples and its scientists' expertise.

Ciphergen said it will have access to the commercial rights of any discoveries made through the collaboration with Johns Hopkins.

Gail Page, president of Ciphergen's Diagnostics Division, said the partnership "will result in rigorously conducted research that can be translated into commercial products that will benefit patients and the healthcare system."

Ciphergen's Diagnostics Division is focused on discovering protein biomarkers and panels of biomarkers and their development into protein molecular diagnostic tests that improve patient care; and provides R&D services through its Biomarker Discovery Center laboratories for new diagnostic tests and theranostic assays.

In other news:

• Huntleigh Healthcare (Eatontown, New Jersey) reported a new three-year contract with Novation (Irving, Texas), the supply company of VHA and the University HealthSystem Consortium (Oak Brook, Illinois), effective April 1, covering Huntleigh's Flowtron Line of Intermittent Pneumatic Compression Devices for the prevention of deep vein thrombosis.

Huntleigh manufactures a range of products for patient assessment: vascular and fetal hand-held Dopplers for non-invasive diagnostic assessment; Intermittent Pneumatic Compression Systems for the prevention of deep vein thrombosis and lymphedema; and pressure-relieving support systems for the prevention and treatment of pressure ulcers.

With an emphasis on public policy, a lot going on now'

SAN FRANCISCO – Medicare policy, of course, is a significant element of public healthcare policy, and Blair Childs, executive vice president of the Advanced Medical Technology Association (AdvaMed; Washington) took time during his presentation at the Frost & Sullivan Medical Devices Executive Summit to salute a comment made by Ron Dollens, president and CEO of Guidant (Indianapolis), during AdvaMed's annual meeting in Southern California earlier this month.

Noting that Dollens had emphasized the point that "public policy is the No. 1 strategic priority" facing AdvaMed and the healthcare industry in general, Childs said: "I thought that was the most concise, right-on thing that I have ever heard."

At present, Medicare may be the most important public policy issue facing the industry association.

Thanks to the Medicare Modernization Act of 2004, Childs said, "a lot of new things [are] going on right now," including:

  • "New technology" diagnosis-related groups and add-on payments.
  • Changed national coverage deadlines, with the ability to get provisional coverage decisions "very fast."
  • Coverage of clinical trials for "breakthrough technologies."
  • Movement to "a more centralized decision process" but maintenance of the local coverage system.
  • Demonstration projects involving coverage for chronic care.
  • Creation of the Council for Technology and Innovation.
  • Reforms in the system for diagnostic payments.

— Jim Stommen, Executive Editor