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Awarded new NIH grant for point-of-care oral HPV diagnostic test development in collaboration with InSilixa

InSilixa

InSilixa Inc. receives a $224,764 NIH grant for the development of a rapid DNA-based, point-of-care (POC) oral human papilloma virus (HPV) diagnostic test

08/19/2015

Sample to answer CMOS biochip platform technology will enable the rapid identification and quantification of HPV types that cause head and neck cancers.

Sunnyvale, CA – August 18, 2015 – InSilixa Inc., the pioneer in the use of CMOS biochip technology for molecular diagnostics (MDx), announces the award of a $224,764 Phase I Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) for the development of a point-of-care (POC) MDx test for the rapid detection and quantification of cancer-causing HPV types in oral samples.

An emerging cancer threat. According to a recent report in the journal Nature, the number of head and neck cancers has been growing over the past 30 years: there are now 10,000 cases in the United States each year, a number that is likely to climb to 16,000 by 2030. An overwhelming majority are caused by HPV and globally it is believed that HPV is responsible for between 45% and 90% of head and neck cancers.  The incidence of these HPV associated cancers continues to grow, as the incidence of tobacco associated head and neck cancers declines.

An unmet medical and public health need. The CDC estimates that 10% of men and 3.6% of women in the U.S. have an oral HPV infection. These numbers are even higher in the context of immune suppression.  However there is no FDA-approved screening test to diagnose HPV in the mouth or throat. “As detection of persistent HPV is among the strongest risk factors for HPV-associated head and neck cancers, the development of such a device would be invaluable”   said Professor Jennifer Webster-Cyriaque of the University of North Carolina, co-investigator on the InSilixa oral HPV detection project.

InSilixa’s unique technology. InSilixa’s proprietary sample-to-answer CMOS biochip technology enables rapid detection and genotyping of pathogens (viruses and bacteria) in clinical samples and the simultaneous identification of their drug resistance profiles using a highly-multiplexed targeted DNA sequencing approach. The first generation of InSilixa’s products will focus on infectious diseases MDx applications in near-patient and POC settings, including the rapid detection of MDR bacteria (“super bugs”) in intensive care units, comprehensive analysis of seasonal respiratory infection outbreaks, diagnosis and drug resistance genotyping of Mycobacterium tuberculosis isolates from patients with TB, the detection, quantification and genotyping of the human immunodeficiency virus (HIV) in  blood samples from patients with HIV/AIDS  and the detection and genotyping of cancer-causing viruses such as HPV. “We are very pleased that NIH continues to support development of the InSilixa platform, in this instance as a potential new tool to screen oral specimens such as saliva for cancer-causing HPV types and to risk-stratify those persons found to be positive ” said Dr. Gary Schoolnik, CMO. “The unique cost and performance of InSilixa’s CMOS biochips make it possible to create viable products in markets that historically have not been addressable by DNA sequencing technologies” said Dr. Arjang Hassibi, CEO of InSilixa Inc.  In this project, this unique InSilixa platform will be leveraged utilizing previously described HPV detection work by Seaman et al. in the Webster-Cyriaque group as a foundation.

About InSilixa

InSilixa, Inc., headquartered in Sunnyvale, CA, is a multidisciplinary, highly motivated and highly technical team comprised of industry veterans with diverse backgrounds in semiconductors, biotechnology, medicine, and informatics. Founded in 2012, InSilixa is driven by the quest to revolutionize the value, power and speed of molecular diagnostics worldwide by leveraging its proprietary semiconductor-based CMOS biochip technology. To that end, the company is developing point-of-care (PoC) and near-patient platforms for the delivery of low cost, high-performance, and mass-deployable solutions for DNA and protein-based diagnostic testing.

The NIH grant described in this Press Release will be supported by the National Institute of Dental and Craniofacial Research of the National Institutes of Health (NIH) under Award Number R43 DE025441 (Hassibi, Arjang, P.I.). The content of this Press Release is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

For more information about the company, technology, products in development or partnering opportunities, please contact info@insilixa.com.

 

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