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FDA Approves Assay For Chlamydia And Gonorrhea.(Gen-Probe Inc.'s Aptima Combo 2 Assay)
2001 JUN 14 - (NewsRx Network) -- Gen-Probe, Inc. has received U.S. Food and Drug Administration approval to sell its target-amplified nucleic acid probe test for the in vitro diagnostic detection of ribosomal ribonucleic acid (rRNA) from Chlamydia trachomatis and Neisseria gonorrhoeae in endocervical and male urethral swab specimens and urine from symptomatic and asymptomatic males and females.
The Aptima Combo 2 Assay is a second-generation nucleic acid amplification test that combines advanced technologies to provide clinical sensitivity and specificity, a choice of specimen types, specimen processing, and specimen transport stability. Both bacteria are detected and identified using a single specimen and test.
Chlamydia trachomatis and N. gonorrhoeae are among the most common causes of sexually transmitted diseases (STDs). Throughout the world, millions of cases go undetected every year. If left untreated, these infections can cause infertility and complications during pregnancy, including fatal ...
- Gen-Probe Receives FDA Clearance to Test Additional Specimen Types for STDs...
- Press release article from: PR Newswire August 22, 2006 700+ words
...FirstCall/ -- Gen-Probe announced today...clearance to use the APTIMA Combo 2(R) assay to...Steve Kondor, Gen-Probe's vice president...healthcare costs." The APTIMA Combo 2 assay is cleared...instruments. Gen-Probe received FDA clearance...specimens with the APTIMA ...
- Gen-Probe Receives FDA Approval for Vaginal Self-Collection Kit for the APTIMA...
- Press release article from: PR Newswire January 6, 2004 700+ words
Gen-Probe Incorporated today announced...gonorrhoeae using the APTIMA COMBO 2(R) assay. "This new indication for APTIMA Combo 2 use is especially pertinent...executive officer of Gen-Probe. The APTIMA Combo 2 assay is used to test...
- FDA approves vaginal self-collection kit for the APTIMA Combo 2 assay.
- Newspaper article from: Health & Medicine Week January 26, 2004 700+ words
...NewsRx.net) -- Gen-Probe, Inc., (GPRO...gonorrhoeae using the APTIMA Combo 2 assay. "This new indication for APTIMA Combo 2 use is especially...executive officer of Gen-Probe. The APTIMA Combo 2 assay is used to...
- APTIMA Combo 2 assay detects chlamydia and gonorrhea infections.
- Newspaper article from: Medical Letter on the CDC & FDA March 16, 2003 700+ words
...com & NewsRx.net) -- The APTIMA Combo 2 assay is effective for detection of...study evaluated the performance of the APTIMA Combo 2 assay, a multiplex assay based on...Clinical Microbiology (Performance of the APTIMA Combo 2 assay for detection of Chlamydia trachomatis...
- Gen-Probe and Tecan Expand DTS Platform for Robotic Processing of The Aptima(R)...
- Press release article from: PR Newswire July 30, 2002 700+ words
...processing of the GEN-PROBE APTIMA Combo 2 Assay, an FDA...market for the APTIMA Combo 2 Assay by offering...segment for Gen-Probe," said Henry...which makes the APTIMA Combo 2 assay ideal for...military. About Gen-Probe Incorporated Gen...
- Gen-Probe Receives FDA Clearance to Run Standalone APTIMA(R) Tests for...
- Press release article from: PR Newswire October 18, 2006 700+ words
...costs." Gen-Probe's primary amplified STD test is the APTIMA Combo 2(R) assay...for STDs with the APTIMA Combo 2 assay on the TIGRIS...this month, Gen-Probe also announced separate...assay. APTIMA, APTIMA Combo 2, PACE and TIGRIS...trademarks of Gen-Probe. ...
- Gen-Probe Receives FDA Approval for STD Testing on the TIGRIS(R) DTS(TM)...
- Press release article from: PR Newswire December 29, 2003 700+ words
...approved to run Gen-Probe's APTIMA COMBO 2(R) assay...System with the APTIMA COMBO 2 assay represents...first for Gen-Probe and for the molecular...system using the APTIMA COMBO 2 assay. Gen-Probe announced on July...
- Gen-Probe Reports Record Fourth Quarter and Year-End 2002 Financial Results; -...
- Press release article from: PR Newswire February 13, 2003 700+ words
...executive officer of Gen-Probe. "During this time...effectively launched its APTIMA Combo 2 assay, which was...products, including Gen-Probe's APTIMA Combo 2, were experiencing...increased sales. * Gen-Probe in strong cash posit
Source: HighBeam Research, FDA Approves Assay For Chlamydia And Gonorrhea.(Gen-Probe Inc.'s...