A Medical Device Daily

Misonix (Farmingdale, New York), a developer of ultrasonic technology for the treatment of cancer and other health conditions, reported the continued expansion of its European high-intensity focused ultrasound (HIFU) business with its entry into Hungary.

The company said it has formed a strategic relationship with Euro-Open KFT for the marketing of Visually Directed HIFU using the Sonablate 500 (SB500) for prostate cancer treatment in Hungary through direct equipment purchases or on a fee-per-use basis.

The SB500 is a device developed by Focus Surgery (Indianapolis) and manufactured and distributed in Europe by Misonix. Visually Directed HIFU is a new, non-invasive technique developed by Focus Surgery and Misonix and is available only with the SB500 device. Misonix has a minority equity position in Focus Surgery.

The company's European HIFU strategy now includes access through in-country and cross-border distribution channels into 11 countries, including some of the largest markets in Europe, such as France, Germany and the UK.

Michael McManus Jr., president and CEO of Misonix, said, “This expansion into the Hungarian market represents another integral step to extend [our] reach in the European HIFU market. [Serving] a population of 10 million people, Hungarian physicians may now offer their patients treatment using our Visually Directed HIFU on the Sonablate 500.”

McManus said the new HIFU procedure would allow patients in Hungary to benefit from access to “far superior results to algorithm-based treatments that require a surgical procedure in advance of the treatment.” He said the technique “represents twice the results, with half the time and in only one procedure, unlike any other HIFU system available today in this market.”

Dr. Zsolt Nemeth, general manager of Euro-Open KFT, said, “We are excited about the prospect of delivering the promise of HIFU that has been proven in other European markets to patients and physicians in Hungary. The device is far superior to other technology we have reviewed.”

Studies boost T-SPOT.TB test's effectiveness

Immunotec (Oxford, UK), which is focused on T-cell measurements, reported the outcome of two studies comparing its T-SPOT.TB assay with other diagnostic tests for latent tuberculosis (TB) infection

Both studies' results demonstrated that T-SPOT.TB is “significantly more sensitive than other diagnostic tests for tuberculosis, far less affected by immunosuppression and is able to provide an accurate result each time a test is carried out,” the company said.

The first study, published in The Lancet, was conducted in Modena, Italy, by Giovanni Ferrara and colleagues. Their study compared the performance of the three main assays for detection of TB infection -- the traditional Tuberculin Skin Test (TST) and two blood assays, T-SPOT.TB and QuantiFERON-TB Gold (QFT) from Australian firm Cellestis in routine clinical practice.

The study involved 383 patients enrolled on suspicion of active or latent TB disease. The key findings of the study were that T-SPOT.TB identified more TB-positive individuals (38%) than did QFT (26%). In their analysis of the results the authors confirmed their belief that the higher number of positive results identified was explained by the higher sensitivity of T-SPOT.TB.

In a sub-cohort of 24 patients with a diagnosis of active disease, 83% (20 patients) were positive by T-SPOT.TB, 74% (17 patients) were positive by QFT with one indeterminate result and 70% were positive by TST (14 patients).

Indeterminate results were reported both for the study as a whole and also for a variety of higher risk sub-groups within the study. An indeterminate result occurs when a test is completed but the result cannot be interpreted. This may be caused by a lack of sensitivity in the assay or by the patient having too few T cells to elicit a response.

The overall difference in indeterminate rates was statistically significant and shows that the QFT assay was unable to produce results in a substantial number of immunosuppressed groups, as well as patients of very old and young age. In contrast, T-SPOT.TB gave evaluable results in 97% of subjects and was only significantly affected by the severe immunosuppression associated with cancer chemotherapy.

Another study completed at the Asan Medical Center (Seoul, South Korea) by a group led by J.Y. Lee was published in the April issue of the European Respiratory Journal, comparing the performance of T-SPOT.TB, TST and QFT in a group of patients with a high clinical suspicion of active TB. The results from this group were compared against a low-risk control group of healthy patients.

The overall sensitivity of T-SPOT.TB in the 87 patients diagnosed with active TB disease was 95.4%, significantly higher than the results achieved with QFT (70.1%) and TST (66.7%). Eight patients gave indeterminate results using QFT, while no indeterminates were observed with T-SPOT.TB.

Peter Wrighton-Smith, CEO of Oxford Immunotec, said, “It is clear from the results presented in these two papers that T-SPOT.TB is significantly more sensitive than its competitors, far less affected by immunosuppression and is able to provide an accurate result each time a test is carried out, with very few indeterminates.”

Firms launch jointly developed IuS microsource

Incoatec GmbH (Hamburg, Germany), a manufacturer of X-ray optics, and Bruker AXS (Madison, Wisconsin), a global provider of X-ray solutions for life and advanced materials sciences, launched their jointly developed IuS X-ray microsource, the brightest sealed-tube X-ray generator eve, at ECM 23 (the European Crystallographic Meeting) in Leuven, Belgium.

IuS is a high-brilliance X-ray source incorporating a 30-watt micro-focus sealed tube together with high-performance Montel multi-layer X-ray optics. The companies said the IuS has no moving parts, a long lifetime without maintenance, is extremely stable, does not require water-cooling, is easy to replace and has low cost of ownership comparable to common sealed tubes.

Incoatec and Bruker AXS said IuS is “significantly more intense than previous microfocus source designs,” providing a photon intensity up to five times higher than a conventional sealed tube system. They said it can be integrated into a variety of X-ray analytical systems for a range of applications.