A Diagnostics & Imaging Week
Telesso Technologies Limited (Sydney, Australia) said it has entered into a strategic agreement with Vascular Pathways (VPI; California), a Delaware company based in California, to fund a multi-center clinical trial of VPI's guidewire device and to potentially acquire VPI.
A peripheral vein is the most common site for insertion of a catheter for short-term diagnostic or therapeutic use. The catheter is placed into the peripheral vein in the arm, below the elbow and is typically passed up inside the vein to a length of 2" to 3".
VPI's technology uses a retractable nitinol guidewire system that Telesso anticipates will result in faster and more reliable peripheral IV placement with less patient discomfort. Telesso said it believes that VPI's device is the first clinically meaningful advancement in peripheral IV access since automatic needle retraction catheters and addresses significant unmet needs in peripheral intravenous access.
Telesso expects that VPI's clinical trials will be conducted at hospitals in the U.S. and Israel.
"I am delighted to enter into this relationship with Telesso Technologies," said Peter Rosenthal, PhD, a member of VPI's board. "Since our technology already has FDA approval, our clinical trial of roughly 300 patients is designed to be a side-by-side comparison with traditional catheters to clearly measure our device's distinct advantages." Trial sites have been identified and the trial is scheduled to begin in the first quarter of 2009.
In other agreements/contracts news, Fujirebio Diagnostics (Malvern, Pennsylvania) and Roche Diagnostics (Basel, Switzerland) have signed a worldwide license and supply agreement for the HE4 ovarian cancer test.
Roche will develop an assay kit using Fujirebio Diagnostics' HE4 test on its automated immunoassay analyzers.
The HE4 test was developed by Fujirebio to be used in conjunction with the company's existing CA125 biomarker, the current gold standard for monitoring ovarian cancer. This combination of biomarkers, as published clinical data shows, provides clinicians with a diagnostic tool that can provide higher sensitivity and specificity than CA125 alone. Improved sensitivity and specificity should allow clinicians to distinguish between benign and malignant pelvic masses more accurately, helping to ensure that patients receive appropriate therapy earlier.
"This novel biomarker HE4 will allow our longstanding partner Roche Diagnostics to provide clinicians worldwide with a much needed tool to better define a pelvic mass, enabling women at higher risk for cancer to see the right physician earlier," said Paul Touhey, president/CEO, Fujirebio Diagnostics.
HE4 in a manual format is currently FDA-cleared for monitoring recurrent or progressive disease in patients with epithelial ovarian cancer (EOC), and CE-marked in Europe as an aid in estimating the risk of EOC in premenopausal or postmenopausal women presenting with pelvic mass. The HE4 manual test and corresponding Risk of Ovarian Malignancy Algorithm (ROMA(TM)) are pending clearance by the FDA for use in women who present with a pelvic mass.