A Medical Device Daily

Cepheid (Sunnyvale, California) and Instrumentation Laboratory (IL; Lexington, Massachusetts) reported the release of the Xpert HemosIL FII & FV assay as a European CE-mark product under the European Directive on In Vitro Diagnostic Medical Devices.

The assay, which delivers results in just over 30 minutes with a single GeneXpert cartridge, detects Factor II (FII) and Factor V Leiden (FV) genetic variations associated with thrombophilia, an increased risk of blood clots.

Developed and manufactured by Cepheid, the test is expected to be available for sale beginning March 4 through IL, which is the exclusive worldwide distributor for the Xpert HemosIL FII & FV assay.

Xpert HemosIL FII & FV is the first test to be commercialized under the exclusive development and distribution agreement for hemostasis molecular diagnostic tests entered into by Instrumentation Laboratory and Cepheid in April 2007.

“Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping,” said Cepheid CEO John Bishop. “The Xpert HemosIL FII & FV assay will allow laboratories to perform the test as needed — and integrate the results with other tests — providing physicians a comprehensive thrombophilia profile of their patients.”

He added, “Given the strength of its HemosIL line of hemostasis assays, IL is the ideal partner for the distribution of this and potentially other important tests for the hemostasis laboratory.”

The companies said FII and FV are the most common hereditary risk factors for venous thrombosis and “are key in the determination of genetic predisposition to the condition and the need for prophylactic treatment in high risk patients.”

They said the investigation of genetic and acquired defects leading to thrombosis is performed with the aid of both classic coagulation assays and molecular tests, but in the past, many of these molecular tests could not be performed in a traditional hospital laboratory. Now, they said, Cepheid’s GeneXpert System enables FII and FV molecular tests to be easily performed in the hospital or independent clinical laboratory without the need for batch processing.

First shipment for CytoCor to Spanish market

CytoCore (Chicago), which is focused on the early detection and treatment of reproductive-tract cancers, reported its first order and shipment of SoftPAP cervical cell collectors to Palex Medical (Sant Cugat del Vall s, Spain), the second company in Europe to launch the CytoCore product.

SoftPAP is designed to collect a full 360-degree specimen from both the cervical canal and the outer surface of the cervix simultaneously resulting in a more complete and comprehensive specimen for Pap testing. Clinical studies have shown that SoftPAP collects a better quality specimen while reducing adverse events, primarily bleeding and spotting, by 95%.

Palex Medical is a medical equipment/solutions distributor to the Spanish hospital market based in the Barcelona area and will be the second company in Europe to launch CytoCore’s SoftPAP cervical cell collector, a device designed to enhance patient comfort and safety while improving the quality of cervical cell specimens for Pap testing.

“We are very pleased to be introducing this important new product to our market,” said Xavier Carbonell, deputy president of Palex Medical. “The collector’s combination of improved patient comfort, ease of use and more reliable test results represents a significant advance in women’s health.”

He added, “We are very interested in CytoCore and its product line. There are several CytoCore products under development that we believe represent opportunities for our markets and clients, and we are looking forward to expanding our relationship with CytoCore.”

“SoftPAP is a vast improvement over the current method, which involves specimen collection using a wooden or plastic spatula and cervical brush,” said Dick Domanik, PhD, president/COO of CytoCore.

U.S. hospital helps UK facility’s approach

Using its “best practice” methods for infection control and patient care, the Hospital for Special Surgery (HSS; New York) has helped a new British hospital lower its infection rates and average length of stay.

When the UK’s National Health Service decided to create a new orthopedic hospital concentrating on joint replacement surgery, it entered into a collaboration with the New York hospital, which is the largest orthopedic hospital in the world.

With a goal of reducing the rate of infection and length of stay after surgery in the new facility, the UK hospital involving HHS at every stage of planning and execution.

As reported in the January issue of The Journal of Arthroplasty, data collected at the South West London Elective Orthopaedic Centre showed that the hospital had decreased its infection rates from 1% to 0.16% and length of stay by an average of five days, from 11 to six.

The decrease was benchmarked against a 2000 national survey by the Royal College of Surgeons and the British Orthopaedic Association that showed for total hip replacement surgery, the average patient stay was between eight and 12 days and the deep wound infection rate was 1%.

Representatives from Hospital for Special Surgery went to London at the beginning, as the construction plans were being drawn up. With infection control a huge issue in the UK and in Europe because of antibiotic-resistant bacteria, the HSS representatives wanted to make sure the hospital was designed to combat the spread of infection right from the start.

“We had the opportunity to go in before the facility was even built, to help them design infection control at every level,” said Eileen Finerty, RN, director of nursing for infection control and occupational health at Hospital for Special Surgery.

Skanska unit gets U.S. hospital contract

Skanska’s (Stockholm, Sweden) Skanska USA Building unit (Parsippany, New Jersey) has been awarded the construction management contract for an addition to the Virginia Mason Medical Center (Seattle). The contract amounts to $114 million (about SEK 730 million).

The new building will include an emergency department as well as operating rooms and intensive care units. The project also involves a new lobby entrance, central utility plant and connections to the existing hospital adjacent to the addition. Construction has started, with completion expected in May 2010.