Carlsbad, CA, April 09, 2017 --(PR.com
)-- AutoGenomics Inc., a molecular diagnostics company offering an innovative and proprietary technology platform for all clinical laboratories announced today the commercial availability of INFINITI® H. pylori Assay. The assay is designed to detect Helicobacter pylori and mutations at 2142G & 2143G on the 23S Ribosomal RNA. Studies show that these mutations are responsible for causing resistance to clarithromycin, the first line drug prescribed for eradicating H. pylori. This newly developed test can be performed on Autogenomics’ INFINITI® Plus and INFINITI® High Throughput System (HTS), which utilize a proprietary multiplexing microarray technology. The INFINITI® H. pylori Assay is for Research Use Only and not for use in diagnostic procedures. AutoGenomics is currently in the process of conducting clinical studies for 510K submission for this assay to the FDA.
Approximately two-thirds of the world’s population is infected with H. pylori. H. pylori is responsible for more than 90% of duodenal ulcers and up to 80% of gastric ulcers. Approximately 25 million Americans suffer from peptic ulcer disease at some point in their lifetime. Each year there are 500,000 to 850,000 new cases of peptic ulcer disease and more than one million ulcer-related hospitalizations. Infected persons have a 2- to 6-fold increased risk of developing gastric cancer and mucosa-associated-lymphoid-type (MALT) lymphoma compared with their uninfected counterparts.
An estimated 1 million new cases of gastric cancer and 720,000 gastric cancer related deaths occurred worldwide each year. The International Agency for Research on Cancer (IARC) of the World Health Organization classifies H. pylori as a Group 1 carcinogen that is responsible for approximately 89% of lower stomach gastric cancer cases.
The American College of Gastroenterology recommends that persons with active gastric or duodenal ulcers or documented history of ulcers should be tested for H. pylori, and if found to be infected, they should be treated. Clarithromycin is one of the most commonly used first line drugs for H. pylori. However, prevalence of clarithromycin resistance has been increasing significantly globally.
According to Dr. Marianne Greene, MD at University of Chicago Medicine and Biological Sciences, "H. pylori eradication is a priority for healthcare organizations. In the US, approximately 32% H. pylori infections are resistant to clarithromycin, the first line drug of treatment for H. pylori eradication. Hence identifying the resistance strain is an important factor in effective management of the disease and would improve patient care and lower costs."
“The release of our H. pylori Assay demonstrates the versatility of the INFINITI® platform to enable rapid development of assays to meet the emerging needs of clinicians to diagnose cancers early and provide effective therapeutic intervention to enhance patient care,” said Fareed Kureshy, President and CEO of AutoGenomics.
AutoGenomics Inc., a privately held company based in Carlsbad, CA, has developed the first automated, microarray based multiplexing diagnostic platform that can be used to assess disease signatures with novel genomic and proteomic markers in the area of genetic disorders, infectious disease, cancer and pharmacogenetics. With the discovery of genes and their link to various disease states the platform has the versatility to revolutionize the way patients are diagnosed, monitored and managed, leading to the era of personalized medicine. www.autogenomics.com