45-minute presumptive identification of H1N1 novel strain expected

Cepheid has announced the accelerated development of a Flu A (Influenza Virus) Panel test for use on the GeneXpert System. The test will be designed to provide 45-minute identification of Flu A infection, with specific presumptive identification of seasonal H1, seasonal H3, and H1N1 novel strain types. Following review of the Request for Consideration for Emergency Use Authorization (EUA) by the US Food & Drug Administration (FDA), the test is expected to be authorized for use during the upcoming influenza season, with product shipments beginning in January 2010.

Heart disease: cholesterol efflux capacity may be the key measurement

The discovery that high levels of high-density lipoprotein (HDL) cholesterol (the 'good cholesterol') are associated with reduced risk of cardiovascular disease has fostered intensive research to modify HDL levels for therapeutic gain. However, recent findings have called into question the notion that pharmacologic increases in HDL cholesterol levels are necessarily beneficial to patients.

Now, a study from researchers at the University of Pennsylvania School of Medicine shows that a different metric, a measure of HDL function called cholesterol efflux capacity, is more closely associated with protection against heart disease than HDL cholesterol levels themselves. Findings from the study could lead to improved understanding of the mechanism behind new therapeutic interventions in the fight against heart disease. The research was published in The New England Journal of Medicine.

Atherosclerosis, a major risk factor of heart disease, occurs with a buildup of fatty materials such as cholesterol along the artery wall. Cholesterol efflux capacity, one measure of HDL function, is a direct measure of the efficiency by which a person’s HDL removes cholesterol from cholesterol-loaded macrophages (a type of white blood cell), the sort that accumulate in arterial plaque. According to the new research, increasing efflux capacity decreased the atherosclerotic plaque development, hence decreasing the likelihood of having coronary artery disease.

Ceramic speech valve offers new hope to throat cancer patients

Manufacturer of ceramic components Morgan Technical Ceramics is working with UK"s University of Hull spin out company, Avoco Medical Ltd, on a pioneering speech-restoration project for patients with throat cancer. The company is taking to market a new patent-protected speech valve that uses zirconia ceramic components which enable valve life to increase, resulting in less frequent valve changes for patients. This improves quality of life for patients and reduces cost to healthcare providers.

Up to 15 per cent of patients diagnosed with throat cancer every year require a laryngectomy (removal of the larynx) which results in speech loss. Some speech and vocal function can be restored through the use of valves which reconnect the trachea (wind pipe) and oesophagus (food pipe). Current valve designs consist of a tube (stent) and incorporate a flap which opens as air is forced through.

Traditionally the valve is made from silicone rubber, but as the material is exposed to a hostile and non-sterile environment a biofilm develops on the surface. As a result, the performance of the valve deteriorates so that it has to be replaced, typically every three months, which is a distressing procedure for the patient and costly to the health service.

Ceramic is a more attractive material because of its stability, biocompatibility and compliance. It has a hard, impervious surface which makes it more resistant to the hostile environment. Laboratory tests have shown that ceramic valves should last more than two years - at least eight times longer than silicone ones.

“We started this project with Avoco Medical two years ago and are pleased that our Zyranox zirconia ceramic has proven to be highly resistant to biofilm during extensive laboratory testing,” says Yannick Galais, Morgan Technical Ceramics. “This longer lifetime of the valve generates less trauma for the patient as the device does not have to be changed so often and it also delivers cost saving for all medical parties.”

“We approached Morgan Technical Ceramics for their ceramics expertise and manufacturing excellence,” says Professor Michael Fagan, Technical Director, Avoco Medical. “The Kingston speech valve includes three ceramic components which need to be precision manufactured so they work together properly. The company has the ability to manufacture the parts to tight tolerances and complex geometries, which is essential to providing high quality and reliable valves.”

Morgan Technical Ceramics offers bespoke components in Zyranox, which is biocompatible and complies with ISO13356 certification for ‘implants for surgery using nonmetallic materials’.

Custom design implantable components are also available in Vitox alumina and Vitox AMC (Alumina Matrix Composite) materials, both complying with the ISO 6474 standards. Applications include reconstructive joints, neurostimulation housings for cochlear implants, Vergus Nerve Stimulation (VNS) and Implantable Pulse Generators (IPG).

CIT appoints Dr François Spézia head of reproductive toxicology department

CIT, a leading European non-clinical CRO, announces today the appointment of Dr François Spézia as head of its reproductive toxicology department. This appointment is a response to growing demand from CIT’s clients for reproductive toxicology studies. These generated 10 per cent of the company’s revenues in 2010, up 25 per cent on 2009.

CIT is one of the few CROs in Europe to have a department devoted solely to reproductive toxicology. The department is staffed by a team of 11 people who are highly experienced and have conducted 183 reprotoxicology studies since 2005.

Enabling technology for next-generation sequencing

Agilent Technologies Inc has announced that it was awarded a US patent for the process used in on-array capture of genomic elements for downstream analysis, including next- generation sequencing.

The patent was issued for a method that uses oligonucleotide probes attached to a solid support as a sequence-specific affinity agent to isolate and facilitate the amplification of a defined nucleic acid fragment mixture. Target enrichment is a critical technique to streamline workflows by letting researchers sequence just the genomic regions of interest rather than entire genomes.

“This patent is another example of Agilent’s innovation and leadership in providing tools for targeted re-sequencing,” said Robert Schueren, Agilent vice president, Genomics. “We are committed to growing our in-solution and on-array SureSelect products, offering scientists unmatched technology for research using next-generation sequencing.”

Last year, Agilent joined researchers from the Max Planck Institute, Cold Spring Harbor Laboratory and other prestigious institutions worldwide to show that the DNA capture techniques described in the patent greatly enabled the sequencing of ancient Neandertal DNA, providing new insight into the nature of these prehistoric hominids. The method, published in the May 7, 2010 issue of the journal Science, uses two rounds of “target enrichment” procedure to enrich ancient DNA from rare and precious bone samples so it can be sequenced.

Agilent Technologies