FDA Approved, CLIA-Waived Rapid HIV Test, Results in as Little as 60 Seconds.

About bioLytical Laboratories bioLytical Laboratories is located in Richmond BC, Canada. Privately owned, federally incorporated Canadian company. Leading developer of rapid diagnostic assays. Exclusive manufacturer of the INSTI® HIV-1/HIV-2 Antibody Test. US TRAINING PRESENTATION

Research & Development bioLytical R&D recently built a pre-clinical prototype for a 60-second Ebola antigen test and are currently developing various Class 1-3 individual and multiplex assays, all on the proven, 60 second INSTI’s platform. bioLytical’s 60 Second Ebola Test announcement in Times Square, NYC. US TRAINING PRESENTATION

INSTI HIV Health Canada Regulatory Approvals 2006 2010 2012 2014 2015 INSTI HIV Health Canada Approved & CE Marked INSTI HIV FDA Approved INSTI HIV FDA CLIA Waived INSTI HIV WHO Pre- qualified INSTI Multiplex CE Marked Approved for sale in more than 58 countries in Europe, North America, Africa, Middle East, Latin America and Asia Approved for USAID / PEPFAR Waiver List World Health Organization pre-qualified ISO 13485 Accredited facility US TRAINING PRESENTATION

Global HIV/AIDS Strategy By 2020 US TRAINING PRESENTATION

Why INSTI? US TRAINING PRESENTATION

1. Instant Results INSTI uses flow-through technology: Reagents are added to the membrane unit well and flow down into an absorbent pad for results in as little as 60 seconds. Most diagnostic assays are lateral flow, meaning fluid has to flow laterally or across to generate a result – usually in the form of one or two lines over 10 - 40 minutes. US TRAINING PRESENTATION

2. Accuracy INSTI is over 99% accurate. Sample Sensitivity Specificity Fingerstick Blood (FSB) 99.8% 99.5% EDTA Whole Blood 99.9% 100% Plasma CLIA Fingerstick Blood* Sensitivity (also called the true positive rate) measures the proportion of actual positives which are correctly identified as such (e.g., the percentage of sick people who are correctly identified as having the condition), and is complementary to the false negative rate. Specificity (sometimes called the true negative rate) measures the proportion of negatives which are correctly identified as such (e.g., the percentage of healthy people who are correctly identified as not having the condition). Source: INSTI HIV-1/HIV-2 Antibody Test Package Insert *Galli RA, Green KF, La Marca A, et al. Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care. J Clin Virol 2013;58 Suppl I:e65-9. US TRAINING PRESENTATION

3. Sensitivity US CDC data shows INSTI as the most sensitive CLIA-waived antibody test, detecting HIV infection 9 days earlier than Western Blot. For Determine, demonstrating sensitivity of Antibody component. Window Period: while INSTI can at times produce a reactive result as early as a few weeks after infection, the window period for RULING OUT HIV infection, i.e. with a negative INSTI result, remains 12 weeks. This is the same window period for all HIV antibody tests, whether in the lab or point of care. US TRAINING PRESENTATION

3. Sensitivity Virological and serological markers of HIV-1 infection Window Period: while INSTI can at times produce a reactive result as early as a few weeks after infection, the window period for RULING OUT HIV infection, i.e. with a negative INSTI result, remains 12 weeks. This is the same window period for all HIV antibody tests, whether in the lab or point of care. US TRAINING PRESENTATION

Center for Disease Control, Source Data Legend: Dark blue (Aptima), RNA Nucleic Acid Amplified Test or NAAT ; Green (Architect, Bio-Rad, and the POC Determine), 4th generation assays detection of antibody and antigen; Blue (Advia, Vitros, GS), laboratory-based antibody detection assays; Pink (INSTI, Multi-Spot, Reveal), flow-through antibody detection assays; Purple (Complete, Stat-Pack, Unigold, OraQuick), rapid Antibody detection assays; Blue (Western Blot), lab-based antibody-detection assay, Brown (Vironostka), lab-based antibody detection assay. CLIA-waived: INSTI (bioLytical), Determine 4G (Alere), Clearview Complete (Alere), Stat-Pack (Chembio), Unigold (Trinity Biotech), OraQuick (OraSure). Recently CLIA-waived, not pictured: DPP (Chembio). US TRAINING PRESENTATION

4. Ease of Use Sample, Pour, Interpret Results Immediately! *All sample collection materials provided (lancet, pipet and alcohol swab.) US TRAINING PRESENTATION

5. Clear, Stable Results US TRAINING PRESENTATION

What is the Significance of a 60 Second Screening Tool? US TRAINING PRESENTATION

Never miss an opportunity to test! INSTI’s 60-Second platform creates greater flexibility for POC healthcare, removing barriers to testing, increasing access to care and empowering testers to adapt to patients’ needs. Never miss an opportunity to test! US TRAINING PRESENTATION

in innovative settings. In Other Words, INSTI: Improves efficiency in traditional healthcare settings, & Creates new opportunities to test in innovative settings. US TRAINING PRESENTATION

1 Minute Models: Real INSTI Users Pharmacy Pre-natal care Emergency Room Pre-natal care AIDS Service Organisation Correctional Facilities Mobile/ Outreach Pharmacy US TRAINING PRESENTATION

Format INSTI (Available in Boxes of 50) Instructions for Use 1 membrane unit 3 reagent solutions Sample collection materials Lancet, pipette, alcohol swab Note: INSTI 24s have been discontinued. US TRAINING PRESENTATION

Contract #: MG01099 US TRAINING PRESENTATION

“Got a Minute?” Feedback & Testimonials “This test is a game-changer and will lead to new ways of reaching people.” -Senior Director of Public Health (AHF) Survey Feedback from bioLytical’s National HIV Testing Day 2014 Campaign: This was the most successful National HIV Testing Day that we have ever had based on the numbers tested and number of target population tested. I love INSTI tests... I would love to use theses tests in the future The product is amazing, the ease of use, accuracy and speed was such a convenient feature for the patient and the tester. I would definitely recommend your product!!! Just started using INSTI and it makes a lot of sense. The earlier detection and the speed offering clients results is a plus. Great test, really easy to use and rapid results. Only test we use during street outreach activities…” US TRAINING PRESENTATION

Contacts: US TRAINING PRESENTATION

Thank You! One minute can change the world. It starts with a test; it start with you. US TRAINING PRESENTATION