Accurate, On-the-Spot Covid-19 Results in 15 Minutes

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GSC Sales Group, Official Dealer for For further information, please contact:

Vincent J. Henderson, CEO GSC Sales Group Dallas, Texas office (972) 895-2872, primary Out-of-state (888) 509-8872 Email: vhenderson@gscsalesgroup.com Mailing Address: 4516 Lovers Lane, #412 Dallas TX 75225

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What Customers Demand From Covid-19 Testing

1. Rapid testing –Test results back quickly, preferably on-the-spot

2. Accuracy – Confidence in the accuracy of results is paramount in controlling the spread of the

virus

3. Mass screening capability 4. Affordably priced

–Supports regular testing programs, as well as, frequent ad hoc testing

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KAYA17 Delivers

KAYA17 offers a quantitative antigen test for detection of Covid19 virus using a nasopharyngeal swab.

✓ Rapid End-to-end solution; testing and results provided on-the-spot,

Delivering results in 15 minutes from sample collection to test result ✓ Accurate

o High detection sensitivity (95%), e.g., superior success in identifying true positives

o Ability to identify presence of virus is 100 greater than other methods resulting in high specificity (98%), e.g., success in identifying true negatives

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KAYA17 Delivers

✓ Mass Testing capability

o 25-30 test per hour per testing station; allows rapid identification of those infected in order to protect others in highly populated environments

o Portable, process only requires laptop and reader

o Testing can be conducted virtually anywhere and allows the flexibility to rotate between locations

✓ Cost effective

o Affordable pricing will allow for frequent testing in any environment, including work, school, healthcare facility, etc.

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Complete On-site Test Solution from KAYA17

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• Vertical flow • Sample processing & imaging • Superior to lateral flow cartridges • High sensitivity measurement

Test kitInstrument

Antigen 1

Cartridge

• No moving parts, small footprint • Wide area sample imaging • High sensitivity measurement • Easy to use software, QR code patient ID

• Proprietary reagents. • 10 minute reaction time • Fewer steps • High specificity assay

15 Minute Test Procedure (nCoV-2 antigen test)

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Total time from sample collection to results is just 15 minutes

Swab the nasopharyngeal

region with a Copan swab

Step 1

Transfer the swab to the tube

with the supplied reagent

Step 2

Add Virus Ex Reagent* into the same tube

and discard the swab

Step 3

Antigen 1

Transfer to cartridge with

preloaded detection reagents

Step 4

Antigen 1

Add Wash buffer and Wait 2mins

Step 5

Cartridge in inserted into the

reader and results are

recorded by the software

Step 6

Compared to Lateral Flow and ELISA:

• Compared to other Rapid Antibody Tests: o Detection Sensitivity: Lateral flow test - 30,000 viruses; ELISA - 3000 viruses; KAYA17 - 30 viruses

o High sensitivity for KAYA17 attributed to novel reader, cartridge & assay

o KAYA17 workflow (15 mins ) is shorter compared to other rapid tests

o KAYA17 system is very affordable, laptop and small footprint reader are the only requirements

o Specificity: KAYA17 test at 98% specificity compared to 83% specificity for a lateral flow test

• Compared to Rapid Molecular Tests: o Expensive due the need for specialty materials ($53/test) and take at least 2hrs

o Instruments for PCR cost $8,000- $20,000 (for single use assay; array machines cost much more)

KAYA17 Technology Proven Superior

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FDA Preclinical Research Facility Review

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Pre-clinical Research Review

KAYA17 will also offer Antibody TestingKAYA17 Anti-nCoV-2 antibody test for detection of antibody in asymptomatic patients

◦ Used for Convalescence Plasma Treatment: ◦ People can be screened for antibodies in the blood

◦ Plasma can be used for the treatment ◦ KAYA17 test gives quantitative results- needed for determining the right donor

◦ Used for Immune screening people before they can get back to work ◦ Positive results implies person has immunity

◦ Quantitative results needed since immunity changes over time

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Test Procedure (Anti nCoV-2 antibody test)

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* Serum Extraction Reagent: Is a proprietary reagent developed by KAYA17 for extraction of antibody from blood leading to higher sensitivity

Total time: Sample to results in 15mins

Add it to Kaya17 Plasma Extraction Reagent*

Antigen 1

Plasma

50µl of the Plasma to each cartridge with preloaded

detection reagents

Cartridge in inserted into the reader and results are recorded

by the software

Finger prick and a capillary is used to

draw 300ul of blood.

Extract plasma using

Centrifuge

Beyond COVID19

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• KAYA17 platform technology can be leveraged for other diagnostic tests • With a minor change to the reagents (change of antibody) we can

provide tests for a wide range of targets. • No change to cartridge and reader is necessary to change from one

test to another except for the calibration curve that is modified in the software. • Currently Validated Tests

◦ Cervical cancer – test validated with patient samples @ AIIMS

◦ Food Diagnostics – test validated for e.coli, salmonella, Listeria

Appendix

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Founder and CEO: Dr. Sulatha Dwarakanath❖ PhD in Cancer Biology at NYU ❖ 20 years of experience in Product Innovation, Development and Strategy

• Sr. Manager at Roche Molecular Systems, Global Medical and Scientific Affairs group in Virology Focused on expanding the business in HIV and Hepatitis space. 

• Sr. Manager at  Integenix (acquired by Thermo Fisher Scientific) Instrumental in setting up processes for manufacturing and regulations. • Lead Scientist at Bayer Diagnostics (Now Siemens Healtheniers). Assay development and clinical trials for cancer markers • Founder and CSO of Nano Science Diagnostics, a Point of Care focused company. Raised $1.5M in private and public funds for food diagnostic products. • Advisory Scientist for Poorna Sudha Foundation in India Set up the Mobile diagnostics unit for cervical and breast cancer diagnosis • Director of AC2 Institute Lead on grants from NSF and DOL. Instrumental in raising $5M funding for ACC Bioscience Incubator.

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Co-founder & VP of Engineering: Dr. Sri Satyanarayana❖ PhD in Electrical Engineering at Columbia University, NY ❖ B.Tech IIT Chennai, Electrical Engineering ❖ 25 years of experience in Product Innovation, Development of analog chips

• AT&T Bell Labs - Neural network chips for character recognition • Philips Research - Application of neural networks or television picture enhancement • IBM - Design of high-speed analog circuits in Silicon Germanium technology • Free Electron Technology - Founder & CEO – Startup in 10Gbps Communication chips, Sold to Cypress Semiconductor • Nano Science Diagnostics - Co-founder & VP of Engineering • Hughes Research Labs - Neural Network chip design • Full power technologies - Design of analog front-ends for wearables & IOT devices • AMD, Ikanos, Qualcomm, Invecas, Synaptics – SERDES chip design 2009 Frost and Sullivan Award for Innovation

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The TeamResearch and Assay development: Dr. Camille Troup, PhD Camille Troup has over 20 years of experience developing and commercializing biomolecular assays, platforms and workflows. Prior to joining SironaDx, she managed translational research projects across multiple platforms for clients at Core Diagnostics as a principal scientist. She is a co-inventor of the ViroSeq™ HIV genotyping assay developed at Applied Biosystems. As a Sr. Scientist at QuantaLife, she developed novel ddPCR applications and played a key role in the acquisition of QuantaLife by Bio-Rad, including supporting commercial adoption of ddPCR after the acquisition. As a senior field application scientist at Nanostring Technologies, she supported translational research programs for Pharma clients and CRO’s. She recently co-authored the biomarker study best practices white paper for the nCounter™ platform. 

Product to Clinical Trail Transition: Anup Madan, PhD A scientific leader with over 20 years of experience in delivering  innovative solutions to support multiple aspects of clinical trials  (early discovery, clinical development and diagnostics). Prior to  joining Sirona Dx, Dr. Madan served as an Executive Director, Genomics at Covance Genomics Lab/LabCorp Clinical Trials, where he was  responsible for all aspects of genomic activities at LabCorp Clinical  Trials. At Covance, Anup played a key role in product development,  evaluating new platforms and cultivating deep relationships with key opinion leaders in the field. held the position of Senior Scientist, Co-Director Research, at Swedish  Neuroscience Institute, Seattle.

Hardware and software development: Dr. Sri Satyanarayana, PhD Electrical Engineering, Analog chip design, Hardware system development. AT&T Bell Labs, Philips research, IBM, FET, NSD, HRL, AMD, Keyssa, Full Power technologies, Qualcomm, Invecas. Founder /CEO of Free electron Technology Inc.

Business development: Kris Kumar Has more than 20 years of marketing experience in the medical device industry.  Experience includes market development and launching disruptive technologies and therapies for small companies in the implantable and diagnostic market segments; in product development and marketing roles at DePuy, Kyphon/Medtronic, Benvenue Medical, SpineGuard, Myoscience (Pacira)

Scientific Advisory board Dr. Alley Tevrizian (Immunologist), Dr. Steve Verbinski (Internist), Dr. George Caughey (Critical care UCSF), Dr. Nancy Mozelsio (Immunologist), Dr. Geetha Bali (Professor)

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Scientific Collaborator: Dr. Rashmi Chowdhry❖ PhD. Sanjay Gandhi Post Graduate Institute of Medical Science (SGPGIMS), Lucknow ❖ M.Phil., Ravi Shankar University, M. Sc., Barkatullah University ❖ Associate Prof. , Department of Biochemistry, AIIMS Bhopal

• Research Scientist at Columbia University New York USA • Research Supervisor/Research Associate (postdoctoral fellow) in WHO_CDC-SEARO-NPSP, Lucknow, India • Senior Research Fellow Virology Laboratory in WHO Fellow, Lucknow, India • Research Assistant in Indian Council of Medical (ICMR) funded Research Project, Lucknow, India • Research Fellow (Trainee) in Department of Microbiology, SGPGIMS, Lucknow, India • Co-PI for Regional Virology Lab at All India Institute of Medical Sciences Bhopal from Department of Health

Research and ICMR, Bhopal, India

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CONFIDENTIAL

Scientific Advisor: Dr. Geetha Bali❖ M.Sc. & Ph.D from Bangalore University ❖ ANSA, Cell Space Research Foundation, Bangalore, Asutosh Mookerjee Fellow

• Head of the Department of Biotechnology and Microbiology , Bangalore University. • Vice Chancellor of Karnataka State Women’s University • Established the Kaushalya Women’s Technology Park • Neurobiology Research in electrophysiological techniques at Goethe University, Frankfurt, W. Germany • Neurobiology Research at Neuroscience Centre at NIMH, Bethesda, USA • President of the Indian Science congress • Awards: Young scientists’ Career Award of the UGC • Fellow of the Indian National Science Academy, Allahabad • IFAS Scholar, University of Florida, USA for promoting scientific interactions between India and USA • Alexander von Humboldt Fellow, Germany • Fellow of Salzburg Seminar, Austria • Millennium plaque of Honor from the Prime Minister of India, • ‘Great Daughter of Karnataka’ from the Governor of Karnataka

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CONFIDENTIAL

Scientific Collaborator: Dr. Rashmi Chowdhry❖ Ph.,D. Sanjay Gandhi Post Graduate Institute of Medical Science (SGPGIMS), Lucknow ❖ M.Phil., Ravi Shankar University, M. Sc., Barkatullah University ❖ Associate Prof. , Department of Biochemistry, AIIMS Bhopal

• Research Scientist at Columbia University New York USA • Research Supervisor/Research Associate (postdoctoral fellow) in WHO_CDC-SEARO-

NPSP, Lucknow, India • Senior Research Fellow Virology Laboratory in WHO Fellow, Lucknow, India • Research Assistant in Indian Council of Medical (ICMR) funded Research Project, Lucknow,

India • Research Fellow (Trainee) in Department of Microbiology, SGPGIMS, Lucknow, India • Co-PI for Regional Virology Lab at All India Institute of Medical Sciences Bhopal from

Department of Health Research and ICMR, Bhopal, India

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