|OraSure Addresses FDA Warning Letter on DNA Genotek; Stereotaxis Announces Completion of Clinical Trial of Vdrive|
|By Staff and Wire Reports|
|Tuesday, 07 January 2014 20:14|
OraSure Technologies, Inc. (Nasdaq: OSUR) announced its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) which the FDA posted today on its website. The warning letter primarily focuses on DNA Genotek's response to two observations issued by the FDA on Form 483 as a result of a routine inspection of DNA Genotek's Ottawa, Canada facilities in September 2013.
DNA Genotek is actively engaged and working with the FDA to address the agency's observations and will continue to sell and market all of its products while responding to the warning letter. No material impact to product sales or OraSure's consolidated financial performance is expected as a result of the issues raised by the warning letter.
The warning letter requests additional documentation related to finished product acceptance testing activities for DNA Genotek's ORAcollect OC-100 collection device, a swab-like product with a small customer base that accounted for approximately one-half of one percent of OraSure's consolidated revenues in 2013. The letter notes that DNA Genotek does not currently have in place an approved premarket approval application or 510(k) clearance for its ORAcollect OC-100 device.
In addition, the warning letter indicates the need for additional documentation regarding design and development activities for DNA Genotek's products and focuses in particular on the design planning and design history file for its 510(k) cleared OrageneDx collection device, a product primarily used in commercial applications. A product similar to OrageneDx, sold under the name OrageneDiscover, is used primarily for research applications and was not specifically addressed by the warning letter.
A copy of the warning letter can be found on the FDA's website at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2013/ucm379997.htm.
"We take this letter from the FDA very seriously and we are working closely with the agency to ensure we fully address their concerns and observations," said Douglas A. Michels, President and CEO of OraSure Technologies. "We are committed to providing the highest quality products to our customers and to continuously enhancing our systems and processes."
Stereotaxis, Inc. (Nasdaq: STXS) announced it has completed the clinical trial required for FDA clearance of the Company's Vdrive™ Robotic Navigation System with V-Loop™ Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510(k) Premarket Notification the Company intends to submit in the first quarter of 2014.
If cleared by the FDA, the Vdrive with V-Loop system will be the Company's second Vdrive product to be cleared for use in the U.S. Its Vdrive with V-Sono™ Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized in more than 50 cardiac ablation procedures to date in the U.S.
The Vdrive with V-Loop system, already part of the clinical routine of several European electrophysiology (EP) labs, is indicated for remotely controlling the advancement, retraction, rotation, tip deflection, and loop size of a compatible catheter. For Niobe® ES remote navigation procedures, the Vdrive with V-Loop system can improve efficiency and accuracy of loop catheter management. In the U.S., an estimated 60,000 loop catheters are used each year in complex EP procedures.
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OraSure Technologies, Inc. (Nasdaq:OSUR) announced that its molecular collection systems subsidiary, DNA Genotek, received a warning letter from the U.S. Food and Drug Administration (FDA) which the FDA posted today on its website.
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