A Medical Device Daily

The Breathalyser is to be launched first in India and South Africa, which are ranked first and fifth, respectively, on the World Health Organization (WHO; Geneva, Switzerland) list of high-burden TB countries.

"The social and humanitarian need for more effective screening is urgent, with TB is at near-pandemic levels in both countries," RBS said.

Concurrent with the launch, RBS will begin the approvals processes that will be required to allow use of the Breathalyser in Europe and the U.S.

The company said the Breathalyser will "revolutionize screening for tuberculosis and other infectious diseases in humans." The device is based on proprietary bio-optical sensor technologies and is both lightweight and portable.

RBS said it also is the "fastest and most reliable method" available for detecting infected subjects capable of transmitting TB to others, providing a result in minutes to a verified accuracy level of 95% or higher.

The company cited WHO statistics indicating that 8.8 million active cases of TB are diagnosed each year and of these, almost 2 million die. "Once thought to be under control or even close to extinction, TB infection levels are rising and the threat is compounded by new, virulent and drug-resistant strains," the company said.

Although most cases occur in the developing world with 22 countries accounting for 80% of all global cases RBS said increasing population mobility, combined with facility of transmission, means that "no country is immune from the resurgence of TB."

CEO Dennis Camilleri said he is confident that the advantages of the device over current screening methods will arouse "significant interest" among stakeholder groups in TB care.

"The most prevalent method of screening currently is the Mantoux TB test, which involves a health worker injecting test fluid under the patient's skin, then waiting for up to 72 hours to see if there is a localised reaction that indicates the presence of TB," he said. "There are, however, many factors that can influence the reaction, meaning that expert assessment — and with it a degree of subjectivity — is involved in interpreting the results. Further, the test is prone to delivering false positives or false negatives, implying that further testing and interpretation may be required.

Camilleri added, "By contrast, the RBS Breathalyser delivers an unequivocal positive or negative result within minutes, with no interpretation required. Significantly, it is highly specific to detecting active TB and is not compromised by the presence of HIV or other co-infections."

He described the unit as "extremely portable and easy to use," noting that it requires no running water or electricity for operation and "can therefore be deployed in remote locations, without the need for subjects to attend a screening clinic."

The performance of the Breathalyser has been validated thus far in a series of clinical trials within a hospital environment in India and in independent trials in Ethiopia supervised by the London School of Hygiene and Tropical Medicine. An additional trial at a WHO-approved hospital in South Africa also is nearing completion.

First RapidArc treatment in SE Asia

A 74-year-old patient with localized prostate cancer has become the Southeast Asia region's first patient to receive treatment using RapidArc radiotherapy technology from Varian Medical Systems (Palo Alto, California).

Clinicians at the Pamela Youde Nethersole Eastern Hospital (PYNEH) in Hong Kong said they were delighted with the first treatment, which took just two to three minutes to deliver, much faster than conventional IMRT (intensity modulated radiotherapy) treatments. "IMRT treatments are time-consuming because tumors are targeted by a complex sequence of fixed radiation beams from multiple angles but the RapidArc treatment is dramatically faster," said T.K.Yau, MD, consultant radiation oncologist.

Yau said the hospital plans to expand the range of RapidArc treatments to include other pelvic tumors and head and neck cancers. PYNEH is one of six public cancer centers in Hong Kong.

RapidArc, which delivers what Varian terms "a precise and efficient treatment in a single or multiple arcs of the treatment machine around the patient," was introduced early last year. Since its launch, more than 70 hospitals worldwide have commenced clinical treatments.

Doctors at PYNEH treat patients using three Varian linear accelerators, including a Clinac 23Ex accelerator equipped with RapidArc radiotherapy technology, acquired in 2008.

Broadened distribution accord for Passlogix

Passlogix (New York) has reported a broad distribution partnership with Salcom Group (Helsinki, Finland) for the Passlogix v-GO Access Accelerator Suite, an integrated set of single sign-on, authentication and provisioning solutions that includes what the U.S. firm says is the market's leading enterprise single sign-on (ESSO) platform.

Salcom Group will distribute the v-GO suite through value-added resellers (VARs) in both the Nordic and Baltic regions, as well as providing training, implementation services and technical support to participating VARs.

The agreement extends an earlier Passlogix relationship that authorized Raxco Finland, one of Salcom Group's divisions, to sell the v-GO platform directly to end-user enterprises in Finland. The new partnership expands Salcom Group's territory as well as its commitment to promoting v-GO to help organizations improve user productivity, network security, regulatory compliance readiness and identity management initiatives.

In Finland, one major use of the v-GO platform is expected to be in hospitals and healthcare centers that must use the Healthcare smart card to gain access to patient information that will be contained in a new centralized database of patient history and prescription information. v-GO will speed access to the database by automating password entry on individual workstations as well as expediting user sign-on and sign-off on shared workstations.