GenePOC Obtains FDA Clearance for Its GenePOC™ Strep A Test in the US

GenePOC Obtains FDA Clearance for Its GenePOC™ Strep A Test in the US

PR Newswire

QUEBEC CITY, March 21, 2019

QUEBEC CITY, March 21, 2019 /PRNewswire/ -- GenePOC Inc., member of the Debiopharm Group, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the revogene™ device.

About Group A Streptococcus (GAS) infection 
GAS is the most common bacterial etiology of pharyngitis accounting for 15 to 30% cases in children and 5 to 20% in adults1. In the United States, approximately 11 to 13 thousand cases of invasive GAS disease occur each year2.

About the GenePOC Strep A assay
The GenePOC Strep A assay is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes nucleic acids from throat swab specimens obtained from patients with signs and symptoms of pharyngitis. The assay can provide results as early as 42 minutes for positive specimens and in approximately 70 minutes for negative specimens, without the need for culture confirmation.

"The GenePOC Strep A assay demonstrated good performance during our evaluation and is a promising alternative to throat cultures and Rapid Antigen Diagnostic Tests (RADT)."
- Amanda Harrington, Medical Director of Microbiology at the Loyola University in Chicago.

It is important to note that about 11 million patients in the US are diagnosed with pharyngitis in the emergency room3. More importantly, over 70% of pharyngitis have a viral cause4. A test completed within an hour can allow physicians to better manage patients.

"The GenePOC Strep A assay can provide 'actionable' results without the need to confirm by culture. GenePOC is committed to developing important assays to complete its current offering, becoming a strong player in the field of rapid molecular diagnostics."
- Patrice Allibert, CEO of GenePOC

About revogene
revogene is an automated and stand-alone device, enabling testing of single-use proprietary microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver an accurate diagnosis.

About GenePOC
GenePOC, a member of the Debiopharm group, specializes in the development of diagnostic devices which enable the prevention and detection of infectious diseases.
Further information: www.genepoc-diagnostics.com 

About Debiopharm Group
Debiopharm Group is a global biopharmaceutical group including five companies active in life sciences. Further information: www.debiopharm.com 

References

  1. Bisno AL et al. Clin Infect Dis. 2002 Jul 15;35(2):113-125
  2. Centers for Disease Control and Prevention (CDC) www.cdc.gov/groupastrep/surveillance.html
  3. Middleton K and Hing E. Adv Data. 2005 Dec 14;(366):1-36
  4. Bower JR. Netter's Infectious Diseases 2012

Contact at GenePOC
Patrice Allibert
CEO
patrice.allibert@genepoc.ca  
Tel: +1-418-650-3535

 

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