OHARA Principal Investigator Advances Study Results by Teaming with DNA Testing Firm to Develop Advanced HPV Test

Jennifer Webster-Cyriaque, DDS, PhD, Professor, School of Dentistry and School of Medicine, University of North Carolina, was a key member of the Oral HIV/AIDS Research Alliance (OHARA) which was funded by the National Institute for Dental and Cranial Research (NIDCR) and the National Institute of Allergy and Infectious Disease (NIAID).  From 2006 to 2013, OHARA worked in collaboration with the ACTG Network to focus on oral opportunistic infection, including research specifically targeting the Human Papilloma Virus (HPV). In all, there were nine OHARA clinical trials that have contributed to the development of a comprehensive oral infection/disease database with HIV/AIDS correlates. An HIV/AIDS oral specimen bank of over 30,000 aliquots and over 1000 fungal aliquots was also developed and will provide valuable material for future epidemiologic and biological research questions.

“The ACTG Network is a special group of individuals all of whom are passionate about making a difference in the global HIV/AIDS epidemic. We had wonderful relationships with our clinical trials specialists and our ACTG colleagues, several of whom were part of the OHARA collaborative group,” said Dr. Webster-Cyriaque. “The ACTG Network was always very inclusive, making us a part of all relevant committees from leadership to laboratory.  I have to say, working with the ACTG Network and with OHARA was overall a wonderful experience.”

OHARA provided the first opportunity for systematic clinical trials in the context of oral HIV/AIDS and provided important insights into oral natural history, oral diagnostics and potential low cost interventions. In order to answer oral objectives for HPV related trials, A5240, A5246 and A5272, Dr. Webster-Cyriaque, alongside the OHARA virology team, developed assays targeting the most common forms of HPV’s.  They were then adapted into a quadrivalent vaccine, a multiplex quantitative assay for types 6, 11, 16 and 18. .  A degenerate quantitative assay was developed and run in parallel that targeted a conservative region of the virus that would potentially pick up any oral HPV.  These first experiments formed the basis of the point of care assay that is now being developed as a biochip with InSilixa Inc., a California based DNA testing firm.  This is a collaborative effort with InSilixa Inc.  under the National Institutes of Health grant #1R43DE025441-01 and it is sponsored by the NIDCR.

“This is exciting news because persistent detection of high risk HPV is the most significant risk factor for cancer development,” said Dr. Webster-Cyriaque. “This test will potentially allow quantitative point of care detection for HPV in oral and other compartments. The point of care aspect is particularly appealing and I am looking forward to harnessing the strength of the biochip.”

Opportunistic infections were critical to OHARA’s focus and the ACTG Network values everything learned during OHARA/ACTG clinical trials, as the mouth is a great monitor for systemic disease.

“We are very pleased that research conducted at our sites is now being furthered by other organizations. Understanding infectious disease pathogenesis in the oral cavity provides a window into lesions and maladies detected in the mouth, ” said Daniel Kuritzkes, MD, ACTG Network Chair and Co-Principal Investigator and Chief, Division of Infectious Diseases at Brigham and Women’s Hospital. “It is our hope that in the future patients will be administered a test like the one developed by Dr. Webster-Cyriaque by clinicians in order to assess current and future HPV risk.”

Dr. Webster-Cyriaque plans to continue her research by following lines of study that will help to better understand oral disease in the context of immune compromise and the different roles viruses play in the development of oral disease.  She hopes to fully understand how the oral microbiota facilitate viral life cycles, influence systemic disease and work to develop interventions and diagnostics that result in improved quality of life for affected individuals.  Additionally, she hopes to work with the ACTG Network in the future and to continue collaboration outside of the formal OHARA structure.

2017 DRRD Presenters

Congratulations to all our presenters at Dental Research and Review Day 2017!

 

William ‘Todd’ Seaman, PhD 

2017 Derek T. Turner Award Recipient

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Anaerobic Bacterial Pathogen Products Mediate Epstein-Barr Virus Reactivation Through Epigenetic Modulation

 

Michael Walker

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Periodontal Bacterium Drives Oxidative Stress in HPV16+ Cancer Cells

 

Beatrice Williams

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The Effect of Oral Health on Overall Self-Perceived Health in Individuals with Recent and  Long-term Human Immunodeficiency Virus (HIV) Diagnosis

 

Liesl Jeffers-Francis, PhD

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BKPyV Etiology in HIVSGD Hyposalivation

 

Jennifer Webster-Cyriaque, DDS PhD

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Clinical Changes and Oral Microbiome Shifts in HIV+ Patients Following Periodontal and Restorative Therapy

 

MANUSCRIPTS, ABSTRACTS, and ARTICLES

It’s always exciting when team members share the results of their research labors!

Click on the links below to read the latest works from

Raquel Burger-Calderon  PhD

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Justin Valentine  DDS, MS

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Jennifer Webster-Cyriaque  DDS, PhD

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Distinct BK polyomavirus non-coding control region (NCCR) variants in oral fluids of HIV- associated Salivary Gland Disease patients

The Mouth and AIDS: Lessons Learned and Emerging Challenges in Global Oral Health

2016 DRRD Posters and Presentations

Sehrish Javaid, Rotation Student

Poster: Porphyromonas gingivalis Enhances Properties Associated with Malignant Transformation in HPV-Infected Oral Keratinocytes

Justin Valentine, DDS

Poster: Impact of Periodontal Intervention on Local Inflammation, Periodontitis, and HIV Outcomes

Janet Doolittle-Hall, Ph.D, Visiting Scientist

Presentation: Validation of Next Generation Sequencing Approaches for Oral Microbiome Studies

Todd Seaman, Ph.D

Poster: Increases in Epigenetic Marks Contribute to Reactivation of Epstein-Barr Virus by Metabolic End Products of Anaerobic Oral and Gut Bacterial Pathogens

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.