Whole Network Cases Diagnostics Functional Food... News Obesity Studies Treatment

 

Gen-Probe Received USFDA Clearance to Run Standalone APTIMA® Tests for Chlamydia and Gonorrhea on the TIGRIS® System

Filed in archive Diagnostics by Gloria Gamat on October 21, 2006

Gen-Probe Received USFDA Clearance to Run Standalone APTIMA® Tests for Chlamydia and Gonorrhea on the TIGRIS® System
The USFDA has granted marketing clearance that allows Gen-Probe Incorporated (Nasdaq: GPRO) to run its standalone APTIMA® assays for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) on the high-throughput, fully automated TIGRIS® system.

Previously approved to run on Gen-Probe's semi-automated instrument system, the two amplified nucleic acidlinks tests detect the microorganisms that cause the most common bacterial sexually transmitted diseases (STDs) in the United States.

According to Steve Kondor, Gen-Probe's vice president of sales and marketing:

"With this clearance, customers can now run on the fully automated, high-throughput TIGRIS system all three APTIMA assays that were previously cleared for use on our semi-automated instruments, depending upon the needs of the patient and the market served.

We believe this clearance gives us the broadest menu of STD products in the industry. In addition, the five approvals or clearances we have received in the last two months illustrate our ability to commercialize innovative, high-value molecular diagnostic tests that help prevent serious medical complications and avoid unnecessary healthcare costs."


USFDA-cleared to run on the TIGRIS instrument in December 2003, Gen-Probe's primary amplified STD test, the APTIMA Combo 2® assay, simultaneously detects CT and GC. The APTIMA CT assay and the APTIMA GC assay received USFDA marketing clearance to run on Gen-Probe's semi-automated instruments in December of 2004 and March of 2005, respectively.

These three assays have been cleared to detect the target bacteria in a wide variety of sample types, including clinician-collected endocervical, vaginal and urethral swab specimens, patient-collected vaginal swab specimens, and female and male urine specimens.

The TIGRIS system is the only fully automated, high-throughput testing
instrument for molecular diagnostics.

Find more details from Gen-probe's press release.






Permalink: Gen-Probe Received USFDA Clearance to Run Standalone APTIMA® Tests for Chlamydia and Gonorrhea on the TIGRIS® System
Tags: STD  Genprobe  TIGRIS  APTIMA  system  standalone+aptima  received+usfda  tigrisÂ+system 

Trackback: http://www.creative-weblogging.com/cgi-bin/mt-tb.pl/39958





RSSrss   | See all blog subscribe options
Google google   |   What is RSS?
Yahoo! yahoo
Addthis Subscribe using any feed reader!
Bloglines Bloglines
Newsletter
Grouptivity

Use the search to look for other interesting posts

pic


 
  • Advertise with us

  • Learn more about our advertising options or email advertising - at - creative-weblogging.com or give us a call at +1 (650) 331 4900.


  • Testimonials

  • 'Thanks, for a very interesting and informative Blog.'

    'Thanks for doing this; it's a terrific site.'

    'I don't know...but why I don't find such informative and profitable blogs so often, I suspect blogging world is becoming so small that we can't find such lucrative blogs like this one.'
Health & Medicine - Top Blogs Philippines

  • Other blogs in the same channel in the Creative Weblogging Network







 

Tagcloud: Allergies Alzheimer's Disease Arthritis Bacteria and Bacterial Infections Blog Carnivals Bone Health Cancer Cardiovascular Health Cases Consumer Alert Controversies Dental Health Diabetes Diagnostics Diarrhea Diet Dietary Supplements and Vitamins Digestive Disorders Epilepsy Eye Health FDA Approvals Functional Foods Genetics HIV & AIDS Influenza Investigational Kid's Health Lung Conditions Lupus Malaria Medical Blogs & Blogging Medical Career Medical Devices Men's Health Mental Maladies Miscellany Multiple Sclerosis Muscular Disorders Nanotechnology Neurological Disorders News Obesity Opinion Oral Health Pain Management Parkinson's Disease Plants & Herbs Poison & Antidotes Pregnancy & Child Birth Psoriasis & Skin Diseases Sexual Health Sleep Disorders Sponsored Post Stem Cell Research Studies Treatment Tuberculosis Viruses and Viral Infection Weight Loss Women's Health