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February 27 – March 6

Feb 27th: Fast-working Biosensor Developed by Rochester Scientists

University of Rochester Medical Center scientists has demonstrated a new technology that accurately and rapidly detects the meat-spoiling and sometimes dangerous E. coli bacteria.

The unique technology uses a protein from the suspect bacteria as part of the sensing system that also includes a silicon chip and a digital camera. It's clearly faster and cheaper than any competing technology. This is another step on the way to point-of-care diagnostics. The technology potentially could detect any biological entity and Rochester research team calls the technology as "arrayed imaging reflectometry." The system utilizes a silicon chip that is made, so that laser light reflected off the chip is invisible unless the target bacteria are present.
A protein from the bacteria, Translocated Intimin Receptor or Tir, is placed on the chip. The Tir can be seen as a "molecular harpoon. The E. coli sends out the harpoon into a cell. Once it is in the cell, the Tir then binds with an E. coli protein called Intimin. A similar process occurs between the Tir placed on the chip and any E. coli in the sample being tested. The binding of the probe and the bacteria alters the surface of the chip. A digital camera image of the chip captures the changes for analysis and confirmation of detection. Traditional methods of detection of bacteria can take days. This technology takes as much time as it takes for a snapshot.

Feb 28th: FDA Approves Emsam (Selegiline) as First Drug Patch for Depression

The Food and Drug Administration today approved Emsam (Selegiline), the first skin (transdermal) patch for use in treating major depression. The once a day patch works by delivering Selegiline, a monoamine oxidase inhibitor or MAOI, through the skin and into the bloodstream. At its lowest strength, Emsam can be used without the dietary restrictions that are needed for all oral MAO inhibitors that are approved for treating major depression. The Emsam patch will be made available in three sizes that deliver 6, 9, or 12 mg of Selegiline per 24 hours. The patch is a matrix containing three layers consisting of a backing, and adhesive drug layer, and a release liner that is placed against the skin.

Emsam has been shown safe and effective for treatment of major depressive disorder in two 6-8 week studies and also in a longer-term study of patients. The data for EMSAM 6mg/24hr support the recommendation that a modified diet is not required at this dose. Patients are advised to change the patch once a day.

Like all approved antidepressants, this product carries a warning of increased suicidality in children and adolescents.

EMSAM was developed by Somerset Pharmaceuticals, Inc. In December 2004, Bristol-Myers Squibb and Somerset entered into an agreement that provides Bristol-Myers Squibb with distribution rights to market EMSAM after approval in the United States. Selegiline was initially approved in capsule form for use in Parkinson's disease.

March 2nd: Amedica Receives FDA Clearance for Its Arx Ceramic Spinal Implant

Amedica Corporation, an emerging leader in the design and development of innovative orthopedic devices, today announced that it has received clearance from the United States Food and Drug Administration (the "FDA") for market distribution of its Arx(TM) Ceramic Spinal Spacer System(TM).

With this FDA marketing clearance, Amedica believes its Arx spinal spacers are the world's first ceramic spinal implants cleared for use in humans. The Arx Ceramic Spinal Spacer System provides innovative, biocompatible implants based on Amedica's patented MC2(TM) technology that offers physicians and patients an alternative to other synthetic and allograft bone implants used for the restoration of spinal anatomy. Such spinal implants are estimated to comprise an annual U.S. market segment of more than $600 million.

Amedica's Arx spinal implants are designed as vertebral body replacements for use in the thoraco-lumbar region of the spine to replace collapsed, damaged or unstable vertebral bodies, resulting from such causes as degenerative disease and/or trauma. These spinal implants combine strength, imaging clarity and bio-mimetic characteristics which the company believes are unique to its products. Amedica anticipates surgeons using its ceramic spinal implants will quickly appreciate the ease of use, reproducibility and predictability provided by its products in spinal procedures. Amedica's ceramic spinal implants uniquely combine strength, with the advanced ability to bind with bone, and simultaneously provide the image compatibility necessary for medical diagnostic imaging.

March 6th: Beckman Coulter Announces FDA Clearance of the UniCel(R) DxC 600i Chemistry-Immunoassay System

Beckman Coulter, Inc. announced today that its newest chemistry-immunoassay workstation -- the UniCel DxC 600i Synchron® Access® clinical system -- has been cleared by the U.S. Food and Drug Administration. The DxC 600i performs both chemistry and immunoassay testing simultaneously from a single point of sample entry. The DxC 600i continues the company's strategy of delivering standardized product lines with large onboard test menus for greater workstation consolidation. With an on-board capacity of 89 reagents, the second generation workcell offers a menu of more than 150 different tests, ranging from cardiac and tumor markers to tests for renal function, diabetes and more.

The DxC 600i will be the only system of its kind with closed-tube sampling (CTS) and closed-tube aliquotting (CTA) capabilities. By eliminating the de-capping and re-capping steps in the laboratory process, these features help increase lab efficiency and enhance operator safety. The system offers output up to 990 chemistry tests per hour and up to 100 immunoassay tests per hour.

Beckman Coulter, Inc. is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes with annual sales of $2.44 billion in 2005 with 71.5 percent of this amount generated by recurring revenue from supplies, test kits, services and operating-type lease payments.

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