A Medical Device Daily
Dutch diagnostics firm Qiagen (Venlo, the Netherlands) has introduced a new molecular diagnostic test to type the HLA-B*5701 allele, a genetic variation in the Human Leucocyte Antigen system.
The company said that HIV patients carrying the HLA-B*5701 marker have a 60% higher risk to develop hypersensitivity reaction (HSR) to Abacavir, which is a component of several widely marketed drugs inhibiting the reverse transcriptase of the HI virus. HSR is a serious, sometimes even fatal multi-organ syndrome that manifests itself in fever, respiratory or constitutional symptoms.
Last month, FDA advised healthcare professionals that all HIV patients should be screened for HLA-B*5701 before initiating treatment with drugs containing Abacavir. Regulatory agencies in other countries, including Germany, issued similar warnings.
The regulatory bodies responded to results from a study published in the New England Journal of Medicine earlier this year. The PREDICT1-1-Study, carried out at the Royal Perth Hospital and Murdoch University (both Perth, Australia) among 1,956 patients from 19 countries, found that HLA-B*5701 is a major biomarker for HSR.
"The screening for HLA-B*5701 prior to Abacavir treatment allows the identification of patients likely to develop HSR. Using HLA-B*5701 tests as a companion diagnostic with the drug therefore helps to better protect HIV-infected patients in treatment from severe additional suffering," said Magnus Ingelman-Sundberg, professor and head of the section of pharmacogenetics at the Karolinska Institute (Stockholm, Sweden).
Ingelman-Sundberg, who was responsible for the commentary on the PREDICT1-study in NEJM, said, "The combination of diagnostics and therapeutics is a key approach to eliminating risks of side effects and therefore increasing the efficacy of drugs."
Qiagen CEO Peer Schatz said, "Our new test is another great example for the advent of molecular diagnostic tests, which can be used to assess the efficacy of drugs. Enabling doctors to customize therapies based on molecular tests which create molecular profiles of patients or diseases ultimately leads to more medical innovation, cost efficiency and – most importantly – to better and safer treatment of patients."
The newly launched test complements a larger personalized medicine portfolio which includes molecular tests related to transplantation, cancer and other therapies.
New health IT leaders in UK
A new leadership team to take forward the UK government's flagship health IT program was identified recently by the Department of Health.
Christine Connelly will be the first chief information officer for health and will focus on developing and delivering the department's overall information strategy and integrating leadership across the NHS and associated bodies, including NHS Connecting for Health and the Information Center. Most recently an independent consultant, she previously was CIO at Cadbury Schweppes.
Martin Bellamy will be the director of program and system delivery. He will lead NHS Connecting for Health and focus on enhancing partnerships with and within the NHS. He has worked for the Department for Work and Pensions since 2003, primarily as CIO of the Pension Service.
Both are expected to begin their new positions on Sept. 22.
Their appointments follow the strategic refocusing of IT leadership as part of the Health Informatics Review into how information can be better used across the Department and NHS.
NHS Chief Executive David Nicholson said, "The creation of these two roles enhances both the strategic management of information in the health and social care system and the delivery of NHS Connecting for Health. Together they bring a breadth of skills and experience that will be invaluable as we continue the roll-out of new and innovative systems that are helping NHS staff to transform the services they provide for patients."
U.S. firm part of NHS contract
In a move to improve patient safety throughout hospitals in England and Wales, the National Health Service Supply Chain (NHSSC) has awarded P3 Medical (Bristol, UK) a multi-year contract to provide patient identification wristbands to the NHS hospitals.
Under the contract, P3 will distribute positive patient identification wristbands from Precision Dynamics (PDC; San Fernando, California). A global leader in automatic identification wristbands, PDC pioneered the first bar-code patient wristband system in 1984 and offers the most complete line of automated wristband solutions worldwide, the company said.
Those solutions include bar code laser printer, thermal printer and RFID.
The National Patient Safety Agency (NPSA), a unit of the National Health Service (NHS), published reports in July 2007 showing that a high proportion of adverse patient safety incidences were linked to the absence of and/or incorrect information on patient ID wristbands.
The NPSA issued a directive for NHS hospitals to begin standardizing wristbands and link them to their IT systems by 2009. In response, the NHSSC awarded contracts to eight suppliers to provide patient ID wristbands to the NHS hospitals, P3 Medical among them.
Simon Talbot of P3 Medical said, "In the UK, PDC's write-on wristbands are already being used by more hospitals than any other. And around the world, their automatic positive patient ID systems have been the cornerstone of the most successful patient safety initiatives at hospitals for over 50 years."
Talbot said that while the vast majority of hospitals in the UK currently use handwritten bands, he's encouraged to finally see the shift toward automated technologies to prevent medical errors. "Hospitals prefer the PDC systems for their ability to meet patient safety needs," he said. "They meet the NHSSC contract needs for both human readable (handwritten) and more advanced (bar code & RFID) wristbands."
Included under the contract are PDC's bar-code positive patient ID wristband solutions, featuring direct thermal bands offered with a choice of plastic snap or adhesive closures for maximum patient security and comfort.