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Alternate-Site Glucose Test Developers Share Clinical Experience With FDA

This article was originally published in The Gray Sheet

Executive Summary

TheraSense will present clinical data related to its FreeStyle alternate-site blood glucose monitoring system to FDA's Center for Devices and Radiological Health Oct. 19 to help the agency consider labeling options for such devices.

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Roche Building Alternate-Site Diabetes Testing Capability Via Amira

Roche Diagnostics will leverage Amira Medical's alternate-site blood glucose testing technology in order to increase its presence in the integrated spot monitoring (ISM) market

Financings In Brief

Athena Diagnostics: Initial public offering of up to $119.7 mil. is outlined in a preliminary prospectus filed Oct. 31 with the Securities and Exchange Commission. The Worcester, Massachusetts diagnostic laboratory's parent firm, Elan Pharmaceuticals, will continue to hold an undetermined portion of Athena equity after the offering and Athena itself will receive no proceeds from the IPO. Athena's four major neurology testing lines include over 70 individual assays for neurogenetic, peripheral neuropathy and paraneoplastic diagnosis services, Alzheimer's disease diagnostics, and neutralizing antibody detection. Athena has 121 employees and offers the assays, many of which are proprietary, directly to neurologists through 41 U.S. sales reps. Revenues in 2000 were up 26.3% to $30.7 mil., generating net income of $5 mil., ahead 56.6%. The firm's largest competitors include commercial laboratories Quest and LabCorp, which also are customers for some Athena assays. UBS Warburg is underwriter for the offering, which is expected to commence in early 2002...

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