Eiken : First Field-based Molecular Diagnostic Test for African Sleeping Sickness in Sight

15 September 2011 – The Geneva-based not-for-profit foundation FIND and Japanese diagnostics company Eiken announced that a next-generation molecular test designed specifically for sleeping sickness – a deadly parasitic disease also known as human African trypanosomiasis (HAT) - is ready to enter accelerated field trials in sites across the Democratic Republic of Congo and Uganda. If all goes well, the LAMP (Loop-mediated Isothermal Amplification) test - which has completed design and development phases - will be available for clinical use in 2012.

The announcement was made at the 31st biennial of the International Scientific Council for Trypanosomiasis Research and Control (ISCTRC), in Bamako, Mali.

Designed to be suitable for use in rural African settings where the disease is most common, the LAMP test promises to dramatically improve the ability to confirm a diagnosis of sleeping sickness - even when parasites are present in low numbers - through detection of the parasite's DNA in patient samples. FIND is also exploring LAMP's utility as a tool to confirm cure after treatment of HAT, which would significantly reduce the follow-up period, and could eliminate the need for repeated lumbar punctures.

If not diagnosed and treated early, sleeping sickness inexorably progresses to a stage where the parasites enter the brain, making treatment more difficult and the likelihood of irreversible neurological damage more likely... [PDF] Eiken's Press Release -

Natus Acquires Embla, Leading Sleep Diagnostic Company

Sep 16, 2011 - Acquisition expected to add $0.08 to 2012 non-GAAP Earnings Per Share -- Natus Medical Incorporated (Nasdaq:BABY) announced that it has acquired Embla Systems LLC, a leader in the development, manufacturing, and sales of devices used in the diagnosis of sleep apnea. Embla is the largest company in the world focused solely on sleep diagnostics (Polysomnography or PSG and Home Sleep Testing). The company offers a wide spectrum of innovative sleep diagnostic solutions including Embletta home sleep testing devices and three leading PSG platforms: Sandman, REMbrandt, and RemLogic, and Enterprise Sleep Business Management Systems. This breadth of product offerings provides a unique set of tools to help optimize the efficiency of sleep labs.

Natus acquired all outstanding shares of Embla capital stock for $16.1 million in cash, exclusive of direct costs of the acquisition. Embla reported revenue of approximately $30 million for its fiscal year ended December 31, 2010.

Natus expects the acquisition will be accretive to earnings in 2012, adding $0.08 to non-GAAP earnings per share for the year. The non-GAAP results will exclude amortization of acquired intangible assets and potential restructuring and other one-time charges related to the acquisition... Natus Medical's Press Release -

Chelsea Therapeutics : New Patent for Use of Droxidopa in Fibromyalgia

Sept. 6, 2011 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8,008,285 entitled "Droxidopa and pharmaceutical composition thereof for the treatment of fibromyalgia." The claims of the patent are related to methods of reducing pain associated with fibromyalgia by administering droxidopa alone, or in combination with other specified medications, to patients diagnosed with fibromyalgia. Chelsea recently completed enrollment of 120 patients in its Phase II trial of droxidopa for the treatment of fibromyalgia. Top-line results of the trial are expected by the end of the year.

Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels... Chelsea Therapeutics' Press Release -