Mobidiag Extends Microbial Diagnostics Platform to Cover Bone and Joint Infections - Sets New World Record of Detecting 64 Dangerous Bacteria in a Single Test

HELSINKI, FINLAND--(Marketwire - May 18, 2009) - the Finnish biotech company Mobidiag announced today two extensions to its record breaking product family as well as excellent results from clinical evaluation of its Prove-it™ Herpes rapid diagnostics product. Mobidiag's new Prove-it™ Bone and Joint assay identifies bacteria responsible for bone and joint infections. The product adds new capabilities to Mobidiag's microarray platform, which also covers sepsis causing bacteria. It can now detect a world record of 64 dangerous bacteria in a single test. Mobidiag's new Prove-it™ StripArray platform enables further extension of assay content and high throughput. The company also announced excellent clinical evaluation results of its Prove-it™ Herpes microarray assay: the product showed sensitivity and specificity equaling or surpassing current methods and found several herpes infections that current tests missed.

"By providing rapid and accurate results, we are redefining infectious disease diagnostics. The evaluation results demonstrate the high performance of our Prove-it technology, and with today's Bone and Joint announcement, our product portfolio now covers a diagnostics market of over 2 million clinical samples per year in Europe," said Mobidiag's CEO Jaakko Pellosniemi.

Excellent clinical performance for herpesviral diagnostics product

Mobidiag's Prove-it™ Herpes microarray assay achieved excellent results in an international multicenter evaluation where the product was compared with current PCR-based methods. Prove-it™ Herpes can identify eight different human herpesviruses simultaneously whereas current tests commonly search for only one type of virus at a time. In the evaluation study, Prove- it™ Herpes showed clinical sensitivity of 92 % and specificity of 98 %. In 20 of the 460 examined cerebrospinal fluid (CSF) samples, the test uncovered pathogens that were not found with the reference methods. Additionally, the test demonstrated 12 multi-infections which were missed by current diagnostics. Prove-it™ Herpes also identified 15 patients with an HHV7 infection not found by the reference methods. In hospital use, Mobidiag's test can reduce costs associated with herpesvirus diagnostics by almost 50 %.

"Due to the wide variety of symptoms, it is difficult to confirm herpesviral infection based only on clinical examination. Rapid diagnostics is vitally important as mortality from untreated encephalitis caused by human herpesviruses can be as high as 50 %. Prove-it Herpes enables rapid diagnostics of the infection and helps doctors choose the correct antiviral treatment," Pellosniemi continued.

Rapid diagnostics for bone and joint infections

Mobidiag also launched the Prove-it™ Bone and Joint product for quick identification of bacteria responsible for bone and joint infections (BJIs), such as osteomyelitis and septic arthritis. Every year, more than 150,000 people within the EU are infected with BJIs. Currently, the diagnosis of BJI's relies on cultures, which are time consuming and subject to false negative results. Mobidiag's Prove-it™ Bone and Joint identifies bacteria directly from a clinical sample in only three hours, and enables targeted antimicrobial treatment to be started quickly. The product adds new capabilities to Mobidiag's microarray platform, which also covers sepsis causing bacteria.

Mobidiag's rapid tests help reduce costs in hospitals. For example, the average time a sepsis patient has to spend in hospital is 12 days and Mobidiag's test can reduce this time 1-2 days for one fifth of the patients the with faster and more accurate diagnostics. In a hospital of 750 beds, this translates to yearly cost savings of over 500 000 euros.

New high throughput technology platform

Mobidiag brings into the market its new Prove-it™ StripArray platform, which enables further extension of assay content and high throughput. With the platform, up to 96 patient samples can be analyzed in an automated process. The new platform provides high reliability, short hands-on time and ease-of-use for the routine diagnostics users. The protocols in the StripArray platform can be fully automated enabling the platform to be used in diagnostic applications requiring high throughput.

Contact:
CEO Jaakko Pellosniemi, Mobidiag Ltd, tel. + 358 40 501 1004,
jaakko.pellosniemi[a]mobidiag.com

Mobidiag Ltd is a Finnish biotechnology company developing, producing and marketing rapid diagnostic tests to hospital laboratories. The company focuses on diagnostics of serious infections with DNA-tests. www.mobidiag.com.