Rapid Detection of Varicella Zoster Virus

1. Rapid Detection of Varicella Zoster Virus One Hour, Point-of-Care diagnostic testing device Satish K. Mehta, Ph.D. Senior Scientist NASA/ JSC/EASI Duane L. Pierson Ph.DChief of Microbiology Dept, NASA/ JSCRobert HardingConsultantRandall Cohrs, Ph.D.University of Colorado Health sciencesDon Gilden, M.D.University of Colorado Health sciences October 26, 2012

2. Overview • A virus detection kit for use with saliva is in development at NASA. • VZV virus that causes herpes zoster (shingles) in adults and chickenpox in children can be detected in patient’s saliva in less than an hour with this kit. • Currently, approximately 1 million people per year in the US are diagnosed with shingles. • Diagnosis of the disease is based upon symptoms and clinical examination. • No definitive laboratory methods exist to diagnose the disease. • NASA and University of Colorado scientists were the first to detect VZV DNA in saliva of astronauts during spaceflight and later in shingles patients. • Using this kit, the virus that causes the disease , can be detected in patients saliva to make an early diagnosis, while the patient is in the doctor’s office . • With this kit, an early diagnosis can be made and early medical intervention can begin to minimize the effects of the disease. • Patients will suffer less nerve damage, thus early recovery and mitigation of debilitating symptoms. • kit will confirm the diagnosis • no false positive or false negative

3. Two approaches to diagnose Shingles in patients Advantages of the new test • Reduces the cost • Early diagnosis and early medical intervention. • May result in lessening disease severity and duration of pain, and less probability of development of post herpetic neuralgia.

4. VZV Detection Kit Assay Concept oligo Detection oligo Detection oligo Detection oligo Detection Detection oligo Y Column Matrix Virus Y Column Matrix oligo Y Detection Column Matrix Microbead Detection oligo

5. IP Status • A non-provisional application was filed February 2011 for this technology. • A provisional application was filed August 2008; • An international patent application was filed in August 2009; • A joint ownership agreement is in place between University of Colorado and NASA. • This technology is part of NASA’s Innovative Partnerships Office (IPO), which seeks to transfer technology into and out of NASA to benefit the space program and U.S. industry. • NASA invites companies to consider licensing MSC-24451-1 and MSC-24451-PCT for commercial applications.

6. What are its features and benefits? Speed: Allows early detection and fast treatment, which improves the effectiveness of shingles vaccines Small size: Utilizes a compact and lightweight design Simplicity and portability: Requires no trained personnel or automated equipment and can be used in a non-laboratory environment, such as a doctor’s office or in space Non-invasive: Takes samples from saliva with no needles Safety: Provides sterile and disposable testing and requires no exposure to infectious agents Sensitivity, specificity, and reliability: Uses antibodies that specifically recognize VZV at low levels, providing reliable results Flexibility: Applies (potentially) to saliva tests for other infectious agents

7. MARKET & COMPETITION • What is the market? • The market here is underserved. The entry of this inexpensive test kit will also develop the market even further. • The market will grow in response to the availability of a cheap test that allows clinicians to conduct in-office screening of at risk patients presenting symptoms. This test provides means to confirm the diagnosis of VZV infection in patients presenting typical symptoms? • The major customers are pregnant women, immuno-compromised individuals, and the elderly <or are the doctors the customers???> • What/Who is the competition? • Currently VZV infection is diagnosed at a somewhat advanced stage based on the clinical presentation of patient symptoms. Confirmation of the diagnosis involves expensive laboratory tests that can take days to weeks. • We offer an inexpensive point of care test that will take less than an hour to perform. • Competitive advantage is protected by our patent.

8. ON-GOING RESEARCH • An advanced standard Microbiology Laboratory equipped with modern scientific equipments is available • The laboratory is staffed by 15 highly trained microbiologists • Analytical capabilities for food, water, air, surfaces, and humans. • Laboratory is fully accredited by CAP, AIHA, and NELAC • Lab is currently involved with: • Operational support of the International Space Station to prevent/mitigate microbiological risks. • Research of microbiology of closed environments (e.g., spacecraft). • Research on microbial virulence under spaceflight conditions • Additionally: • Biosafety level 2 facility • Bacteria, fungi and virus culture capabilities • Advanced molecular techniques; PCR, sequencing, DNA fingerprinting and Tissue culture • <any words on PI expertise?>

9. Summary The unique aspects of the device make it an excellent tool for diagnosing infectious disease. Specificity of the two antibodies create a reliable test for the targeted virus. An additional innovation is the device itself, which uses a lure lock and disposal bag, allowing saliva samples to be captured and tested without subjecting anyone to the virus. Because the device is lightweight, portable and easy to use, the test can be given anywhere – an office environment, lab, or space