AutoGenomics INFINITI® H. pylori Assay is CE-marked for international markets

Novel PCR based test detects Helicobacter pylori and resistance to clarithromycin in biopsy and stool

Press Release ( - CARLSBAD, Calif. - Aug 03, 2017 - AutoGenomics Inc., a molecular diagnostics company offering an innovative and proprietary technology platform for clinical laboratories announced today the availability of the INFINITI® H. pylori Assay as a CE-marked product. The assay is PCR based providing a high level of sensitivity and specificity and can be used on biopsy and stool samples. The INFINITI® H. pylori Assay detects Helicobacter pylori and determines a patient’s resistance to clarithromycin, the first line drug prescribed for eradicating H. pylori.  The INFINITI® H. pylori Assay can be performed on AutoGenomics’ INFINITI® Plus and INFINITI® High Throughput System (HTS) and is designed to meet the needs of small and large volume laboratories.  The company will present a scientific poster at the 69th AACC Annual Scientific Meeting and Clinical Expo held in San Diego, CA from July 30th to August 3rd, 2017.  The title of poster is “Automated Molecular Detection of Helicobacter pylori and its Resistance to Clarithromycin in Human Tissue Biopsies.”

H. pylori infection affects nearly half of the world’s population.  H. pylori is associated with peptic ulcer, gastric ulcers, mucosa-associated lymphoid tissue lymphoma and gastric cancer. (Elvira et al). In developing countries, the prevalence of infection is as high as 90%.

An estimated 1 million new cases of gastric cancer and 720,000 gastric cancer related deaths occur 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.3

“With the addition of the INFINITI H. pylori Assay, we now have 26 CE-marked molecular diagnostic tests and two CE-marked instruments to serve the international market in the areas of personalized medicine, oncology, women’s health and infectious diseases. We will continue to expand the breadth of our menu to address mid to high volume tests in these market segments.”- said Fareed Kureshy, President and CEO of AutoGenomics.

About 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.

Source : AutoGenomics

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