A Medical Device Daily

Cepheid (Sunnyvale, California) and Instrumentation Laboratory (IL; Bedford, Massachusetts) reported that Cepheid has received FDA clearance to market its Xpert HemosIL FII & FV test. The test detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots (thrombosis).

Xpert HemosIL FII & FV delivers results in just over 30 minutes using a single GeneXpert cartridge.

Developed and manufactured by Cepheid, the test will be available worldwide through a partnership with IL, the exclusive worldwide distributor for the Xpert HemosIL FII & FV test.

"The Xpert HemosIL FII & FV test is the first product developed in conjunction with our partnering model to be marketed in the U.S.," said John Bishop, Cepheid's CEO. "Programs such as this have been strategically developed to help provide incremental leverage in the development of a broad test menu for our GeneXpert System. The Xpert HemosIL FII & FV test will enable laboratories to perform the test immediately – and integrate the results with those from other tests – providing physicians a more comprehensive thrombophilia profile of their patients."

Testing for genetic and acquired defects, which may lead to thrombosis, is performed with the aid of both classic coagulation assays and molecular tests. In the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Cepheid's GeneXpert System enables rapid FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory.

"The availability of an FDA cleared test for FII & FV polymorphisms that is rapid, accurate, easy to use and performed on-demand is important for several reasons," said Alan Wu, PhD, chief of the Clinical Chemistry, Toxicology and Pharmacogenomics Laboratories at San Francisco General Hospital & Trauma Center and the University of California, San Francisco.

In other products news:

• Axial Biotech (Salt Lake City) reported that its Scoliscore AIS Prognostic Test is now being made available to spine specialists in the U.S. Scoliscore is a saliva-based genetic test designed to predict the risk of progression of scoliosis, an abnormal lateral curvature of the spine. Spine surgeons from 40 medical centers throughout the U.S. were introduced to the test and have been defining its clinical use since December 2008. DePuy Spine (Raynham, Massachusetts) will market the test for Axial.

One hundred thousand children are diagnosed with scoliosis every year in the U.S. and must be followed on a consistent, often quarterly basis, to determine and assess disease progression. The Scoliscore Test is designed for male and female patients diagnosed with Mild (10-25 degree Cobb Angle) adolescent idiopathic scoliosis who are ages nine through 13 years, and who are self-reported as Caucasian (North American, South American, European, Eastern European, Middle Eastern, Southwest Asian Descent).

"The Scoliscore Test, along with other diagnostic testing and clinical examination, enables the physician to confidently recommend a personalized treatment regimen for each patient at the first sign of the disease," said John Climaco, president/CEO of Axial Biotech. "Scoliscore and other tests in our product pipeline have the potential to completely transform treatment paradigms and ultimately to lead to improved and more efficient patient care."

• Reverse Medical (Irvine, California) has received FDA conditional approval to begin a neurothrombectomy IDE study for its ReStore Microcatheter at 20 U.S. centers. The study is planned to begin enrollment in U.S. and European hospitals following investigating study center Institutional Review Board (IRB) approvals. Study enrollment will involve approximately 120 subjects which present within eight hours from symptom onset.

Reverse Medical's CEO Jeffrey Valko said, "This conditional IDE approval of the Reverse Medical ReStore Microcatheter represents another important strategic step forward for our rapidly growing company. We will begin patient enrollment early in 2010, following IRB approvals from our investigating study centers."

• Finesse Solutions (San Jose, California) has released TruViu RDPDmini, a vessel utility tower system for laboratory scale bioreactors, such as glass vessels (<10L) or single-use rockers. The RDPDmini package extends the TruViu family into low-cost, small footprint applications. TruViu RDPDmini consists of a compact utility tower, and/or an optional gas manifold. TruViu RDPDmini brings the benefits of industrial automation reliability and scalability in a very affordable package. It is compatible with both DeltaV and Intel microcontroller system platforms. It interfaces easily with Finesse TruBio software (either DeltaV or Windows CE) to deliver optimal bioprocess control.

• Toshiba America Medical Systems (Duluth, Georgia) has introduced low-contrast imaging for Toshiba's Infinix-i systems with mid (12" x 12") and large (12" x 16") flat-panel detectors. The company said the Infinix-i line features a five-axis C-arm that enables head-to-toe and fingertip-to-fingertip coverage and allows greater clinician access to the patient for diagnostic and interventional procedures. The freely moving components, ergonomically friendly design and five-axis positioner enable physicians to obtain optimal angles for cardiac diagnosis and interventional procedures without repositioning the patient.