Tag: infectious diseases

Company News: Curetis AG Signs Distribution Deal in Middle East with ATC

– Kuwait Ministry of Health clears Unyvero™ Solution for clinical evaluation –

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that it has signed an exclusive distribution deal for its Unyvero™ solution with Advanced Technology Company K.S.C. (ATC). ATC will become the exclusive distributor of the Unyvero Solution including consumables for the six Gulf Cooperation Council (GCC) countries and the Lebanon.

Placement of instruments will start in the third quarter this year. A clinical evaluation project of the Unyvero™ Solution has been approved by the Kuwait Ministry of Health and will take place at leading clinical sites in the country. Curetis, ATC and the clinical investigators will cooperate closely during this phase, and are planning to publish evaluation data in 2013 at a renowned international medical conference.

Company News: Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commercialization

– Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national and international commercialization activities. The performance evaluation of Curetis´ Unyvero™ System and the Unyvero™ P50 Pneumonia cartridge was successfully completed just recently.

The evaluation has demonstrated excellent performance characteristics of the Unyvero™ pneumonia application in terms of sensitivity and specificity. Overall sensitivity in 186 tested fresh and frozen clinical sputum, aspirate and lavage samples was above 75% sensitivity with a better than 95% specificity. The Unyvero™ P50 pneumonia application cartridge identified 74 additional pathogens missed by standard microbiology culture, which was used as gold-standard comparator in terms of performance. If confirmed with independent methods this might demonstrate that the Unyvero™ pneumonia test offers significant improvements in terms of sensitivity over current clinical standards. This analysis is ongoing.

Cartridge and instrument system have also passed other important criteria, such as repeatability, reproducibility, interference testing, and cross-reactivity. The complete performance evaluation study included 318 Unyvero™ P50 cartridge runs between January and April 2012.

Based on positive feedback from many potential distribution partners during the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) earlier this year, Curetis has also begun establishing its international distributor network and expects to target an even broader international market than originally anticipated beginning in 2012/13 already.

Food for Thought: Weekly Wrap-Up

Die Welt this week reports on plans by BayerCropScience, a division of Bayer AG, to develop new, heat- and drought-resistant wheat varieties. To accomplish this goal, BayerCropScience will refrain from introducing novel genes into the wheat genome for fear of protests in Europe. However, the company is cooperating, among others, with Israel-based Evogene to also develop genetically engineered crops for other markets.

Michael Simm in Focus features the latest accomplishments of synthetic biology in which researchers control artificially introduced networks of genes in cells and tissue. As an example, scientists from the Department of Biosystems Science and Engineering (D-BSSE) in Basle, Switzerland, have inserted genes for hormone production into cells. By adding genetic control elements that can be switched on by irradiation with blue light these genes can be controlled from outside. As an example, the researchers in vitro introduced a genetic network for the production of insulin into human tissue which subsequently was micro encapsulated and transplanted to the skin of diabetic mice. After a meal, blue light is applied to switch on insulin production in order to normalize blood sugar levels. The model works well so that the researchers are thinking about clinical trials. Already, the use of light to switch on genes has led to the new scientific discipline of optogenetics which is exploring light-controlled genes and cells to treat diseases such as Parkinson’s or epilepsy. D-BSSE researchers also developed cells carrying a network of genes that is able to normalize uric acid levels in gout patients.

Siegfried Hofmann in Handelsblatt is introducing various therapeutic approaches of biopharmaceutical companies in a series entitled “future lab 2020.” Topics range from personalized medicine to stem cell therapies to novel immune therapies.

David Shaywitz in Forbes provides a thoughtful article explaining why Silicon Valley failed to make a dent in the healthcare space: “most tech-savvy entrepreneurs lack an in-depth appreciation for the complexity of medicine in general, and the nuances of the doctor-patient dynamic they are confidently trying to influence or replace.” He goes on to say that management of high-tech companies needs to understand the science: “When a science-driven business is led by leaders who don’t even know what they don’t know, and who actually believe that the crisp powerpoint slides that bubble up for their review actually and adequately represent the science involved – then you risk making some very ignorant decisions.”

The New Scientist this week features a story on how cancer cells can be poisoned with  2-deoxyglucose. The sugar dislodges a protein protecting a suicide switch which subsequently can be triggered by ABT-263 navitoclax, a molecule under development at Genentech. The magazine also reports on a call for proposals by DARPA, the US military’s research arm, to develop small interfering RNA (siRNA) to fight bacteria. DARPA is seeking ideas for adaptable nanoparticles that can be reprogrammed “on the fly” by loading up specific siRNA to deal with outbreaks among troops.

And finally, the Economist features people pioneering the backyard generation of fuel to power their diesel cars. The recipe starts with collecting used kitchen oil, which after some filtering is broken down into esters and glycerol by adding sodium hydroxide and methanol and heating. Glycerol is drained away and the remainder is washed with water to get rid of impurities. Removing residual water and moisture is done with an aquarium bubbler. The resulting biodiesel, the article states, can be used in diesel cars without any modification. Already, British company Oilybits is selling devices to produce 120 liter batches of biodiesel in a more professional way.

Company News: Curetis AG Successfully Increases Series A Round to EUR 24.5 Million

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced an extension of its Series A financing, bringing the total size of the round to € 24.5 million. CD-Venture joined the funding as a new investor, while all of Curetis’ existing VC investors participated in the round. Several private investors also continued to co-invest.

Following the appointment of Oliver Schacht, PhD, as the new CEO of Curetis last month, this financing transaction is the first step towards funding next year’s commercial launch and roll-out of the Unyvero product platform together with the first CE marked IVD test cartridge for pneumonia and antibiotic resistances in Europe. The additional funds will allow Curetis to pursue a more aggressive strategy towards initiating a US clinical trial in H2-2011 with a goal of filing for FDA approval in 2012. This Series A financing positions Curetis as a solidly funded molecular diagnostics company with near-term commercial-stage products and its unique platform solution addressing a clear unmet medical need in the rapid diagnosis of infectious diseases and antibiotic resistance.

Curetis’ CEO Oliver Schacht will present an update on the company at the upcoming BioEquity 2011 in Paris. The presentation is scheduled for May 23, 2011, at 5:00 pm CET, Room Pont de Sully.

Further details can be found here.

 

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