REVOLUTIONARY, YET ABSURDLY SIMPLE DRIED MATRIX MICROSAMPLING DEVICE

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1 REVOLUTIONARY, YET ABSURDLY SIMPLE DRIED MATRIX MICROSAMPLING DEVICE Coect a 10 µl Dried Sampe Every Time Goodbye Ice, Centrifuges, & Freezers Easier & Faster than DBS Cards No Voumetric Bood Hematocrit Bias Supports NCR Initiatives

2 MICROSAMPLING DEVICE A NEW ERA OF DRIED MATRIX MICROSAMPLING Wecome to ABSURDLY SIMPLE Microsamping Easiy and economicay coect, transport, extract, and anayze 10µL, dried matrix bioogica fuid sampes to generate dependabe, quantitative bioanaytica data with reduced or eiminated bood hematocrit bias. 1 COLLECT SAMPLES, ANYWHERE, IN SECONDS MINIMAL SAMPLING TRAINING NEEDED DRY SAMPLES AT AMBIENT TEMPERATURE 5 C 5 C 5 C 5 C TRANSPORT SAMPLES VIA POST 5 C Mitra (RUO) is deveoped and manufactured by Neoteryx LLC. Mitra (RUO) is distributed and supported by. For research use ony (RUO). Shoud not be used for cinica diagnostics or to serve any medica purpose. Try absurdy simpe microsamping in your ab today YouÕ know exacty what we mean! 014, Inc. A rights reserved. 5 EXTRACT AND ANALYZE SAMPLES WITH COMMON METHODS

3 REVOLUTIONARY TECHNOLOGY, SIMPLE DESIGN 4 COLLECT A 10 µl, DRIED SAMPLE EVERY TIME 5 TABLE OF CONTENTS SIGNIFICANT COST AND TIME SAVINGS 6 STREAMLINED WORKFLOW 7 AUTOMATABLE 96-WELL PLATE FORMAT 8 SAMPLE ANYWHERE CLAMSHELL FORMAT 9 CONSISTENT SAMPLE QUALITY WITH GOOD LINEARITY 10 REDUCED OR ELIMINATED BLOOD HEMATOCRIT BIAS 11 RESOURCES 1 ORDERING INFORMATION 14

4 REVOLUTIONARY TECHNOLOGY, SIMPLE DESIGN Based on Voumetric Absorptive Microsamping (VAMS ª ) technoogy, the patent-pending Mitra (RUO) Microsamper is a simpe, eegant device attuned to bioogica fuid coection. The design features faciitate high-throughput sampe processing, fuid draws from ive hosts or tubes, and the abiity to coect precise microsampes with imited training and no speciaized ab equipment. THE MITRA MICROSAMPLER SAMPLER BODY FEATURES Leverage Existing Liquid Handers to Increase Sampe Processing Throughput Ribs prevent sampe from contacting was of extraction pate and camshe Barre can be abeed or written on Dista end fits standard 0-00 µl pipette head Ribs 4 WHY 10 µl? Barre For studies where the therapeutic range is in the µg / ml range - a 10 µl microsampe is sufficient. In addition, you can achieve more consistent and better quaity data with seria vs. composite samping. Lasty, microsampes are a huge eap forward in anima wefare by reducing the number of animas needed for testing to a fraction supporting the NCR initiatives to Repace, Refine, and Reduce. SAMPLER TIP FEATURES Coect 10 µl Every Time in Seconds Regardess of Bood Hematocrit Leve Hydrophiic porous materia rapidy wicks fuid Fixed, highy reproducibe interna voume Dries in hours or ess Dried sampes are not a biohazard eiminating specia transportation needs and costs Extraction foows simpe, automatabe procedure Dista end

5 CONSISTENTLY COLLECT DEPENDABLE MICROSAMPLES Voume of Whoe Bood Coected With the Mitra Microsamper vs. Hematocrit (HCT) Percentage COLLECT A 10 µl, DRIED SAMPLE EVERY TIME Voume (μl) % HCT 45 % HCT 70 % HCT The overa average voume coected is 10.1 µl with an overa reative standard deviation (RSD) of 4.0 % iustrating that the Mitra Microsamper dependaby coects 10 µl every time regardess of bood hematocrit eve. 5 COLLECTED SAMPLES DRY IN HOURS OR LESS Time Required for Mitra Microsamping Tips to Dry after Samping 1.0 Mass of Bood on Probe (mg) Tips in Open Air Tips Encosed in Camshe Tips Encosed in Camshe, Seaed in Bag with Desiccant Time (hours) A three scenarios evauated in the drying time study were done under ambient conditions at 10 % humidity and room temperature. Compete dryness was achieved in two hours or ess in each instance, even when Mitra Microsamping Tips were not directy exposed to open air.

6 SIGNIFICANT COST AND TIME SAVINGS The Mitra (RUO) Microsamper combines the best of wet samping, microsamping, and dried bood spotting into one, state-of-the-art coection device that is extremey simpe to use. Massive cost and time savings can be achieved when using the Mitra (RUO) Microsamper as opposed to other typica coection techniques. COMPARISON OF THE MITRA MICROSAMPLING DEVICE TO COMMON SAMPLING TECHNIQUES Coects a fixed voume of bood, regardess of bood hematocrit Can be transported without dry ice or biohazard needs Mitra (RUO) Microsamper Dried Bood Spotting (DBS) Traditiona Wet Samping Direct samping approach (e.g. finger or tai prick) 6 Robust, consistent samping technique with minima training needed No sampe processing required (e.g. centrifugation, isoation, spot punching, etc.) Q: How much money and time woud you save if you no onger had to transport sampes on dry ice or by courier? If you didn«t have to do reworks? If you didn«t have to pre-process your sampes? A: The Savings is Shocking...Isn t it?

7 Study ID: 145 Subject ID: abcde Nomina Time: xxx Patient Initias: Study ID: 145 Subject ID: abcde Nomina Time: xxx Patient Initias: MICROSAMPLING DEVICE TYPICAL WET WORKFLOW Labe Tube STREAMLINED MITRA MICROSAMPLING WORKFLOW Labe Camshe STREAMLINED WORKFLOW 1 1 Coect Sampe Coect Sampe Centrifuge Dry Under Ambient Conditions Transfer Transport by Post 4 4 Freeze Extract with Common Sovents Transport by Courier (on dry ice) 6 Anayze Is it reay that simpe? It sure is. Downoad the Quick Start Guide at mitra/resources to confirm. Thaw 7 Extract 8 Anayze 9

8 AUTOMATABLE 96-WELL PLATE FORMAT The Mitra (RUO) Microsamping Device is avaiabe in two formats: a 96-We Pate assemby and a 4-Pack Camshe. Your study requirements such as sampe size, subject type, sampe coection ocation, and throughput needs wi dictate the best format to use. 96-WELL PLATE FORMAT This format has standard indexing and fits SBS footprint of your iquid hander when used with the Mitra Deck Adapter, resuting in faster sampe processing by using pate mapping software & instrumentation aready present in your ab. RECOMMENDED FOR: Discovery and pre-cinica environments Anima studies Automated sampe processing Method deveopment 8 STORAGE BOX The Mitra Samping Too assists in picking up the Mitra Sampers from the 96-we drying rack and can aso be used to take the sampe. MICROSAMPLERS (X96) DRYING RACK

9 SAMPLE ANYWHERE CLAMSHELL FORMAT 4-PACK CLAMSHELL FORMAT Coect patient sampes anytime, anywhere by anyone with this practica, user-friendy format, which requires minima training for robust samping technique. Simpy appy patient abe to camshe, open, coect sampes, cose, et dry, and drop in the mai. RECOMMENDED FOR: Cinica environments Human studies At-home samping Remote ocations 9 CLAMSHELL See Mitra (RUO) Microsamping Device formats in action in the product demonstration videos! MICROSAMPLERS (X4)

10 CONSISTENT SAMPLE QUALITY WITH GOOD LINEARITY The Mitra (RUO) Microsamping Device reduces or eiminates the voumetric bood hematocrit assay bias probem associated with dried bood spotting (DBS) cards resuting in accurate and dependabe bioanaytica data. In addition, because the Mitra (RUO) Microsamper coects a fixed voume every time, sampe quaity is aways consistent and no punching is required. COLLECT A PERFECT SPOT EVERY TIME Dried Bood Spotting Vs. Mitra Microsamper Layering Insufficient, mutipe appication Serum rings present Homogeneous 10 µl Sampe EXCELLENT LINEARITY AND CHROMATOGRAPHY FOR IMMUNOSUPPRESSIVE DRUGS FROM A WHOLE BLOOD MITRA EXTRACTION Linearity Curve for Tacroimus 10 Anayte Area / IS Area Anayte Conc. / IS Conc Good inearity was found for immunosuppressive drugs tested (Cycosporine, Siroimus and Tacroimus). The above exampe is for Tacroimus where inearity was achieved across the fu caibration range ( µg/ml). Furthermore the curve showed an r vaue of showing good precision and no positive or negative bias. 5.e5 5.0e5 4.5e5 4.0e5 Typica Chromatogram of Antirejection Drugs from a Whoe Bood Mitra Extraction Intensity, cps.5e5.0e5.5e5.0e e5 1.0e5 5.0e4 Acknowedgements Data generated at St James's hospita Leeds UK by Stephen Stephenson min Very cean chromatograms are achieved from a simpe whoe bood extraction of the immunosuppressive drugs enabing easier quantitation.

11 CASE STUDY: Naproxen Extractions from Whoe Human Bood Coected With the Mitra Microsamping Device Therapeutic concentration ranges for Naproxen are used to evauate both hematocrit bias and assay stabiity. The extraction methodoogy is methano and 15 minutes of vortexing for a the data. This case study supports the caims that the Mitra Microsamper greaty reduces or eiminates hematocrit bias compared to DBS Assay Bias and is a stabe dried matrix coection device. REDUCED OR ELIMINATED BLOOD HEMATOCRIT BIAS EXTREMELY LOW HEMATOCRIT ASSAY BIAS 40 Naproxen Assay Bias (Hematocrit Bias) Commony Observed DBS Assay Bias 0 Acceptabe Research Assay Bias µg/m 0 8 µg/m 40 µg/m 10 DBS Assay Bias % 0 0 % HCT 45 % HCT 65 % HCT Acceptabe Research Assay Bias Commony Observed DBS Assay Bias Hematocrit bias at three different concentrations of Naproxen (, 4, and 8 µg / ml) and three different eves of bood hematocrit (0 %, 45 %, 65 %) is iustrated. A ±1 % assay bias is the maximum observed which is within the typica ± 0 % accuracy accepted for research assays and significanty beow the 40 % assay bias that can be seen for DBS with a sub-punch processing step. DEPENDABLE SAMPLE STABILITY Assay Stabiity of Naproxen over 14 Days 0 µg/m Sampe µg/m Sampe 40 µg/m Sampe 15 DBS Assay Bias % Day 1 Day Day 5 Day 9 Day 14-0 This graph iustrates on-tip stabiity for an anaysis of Naproxen over 14 days. A the data fits within the ±15 % assay bias requirement iustrating that the stabiity of the assay is good for at east up to weeks. Time

12 RESOURCES IN-LAB DEMONSTRATIONS & SEMINARS PRODUCT EVALUATIONS FREE SAMPLE 1 IN-LAB DEMONSTRATIONS & SEMINARS WeÕ bring absurd simpicity right to your doorstep! Try the Mitra (RUO) Microsamper out for yoursef, in your ab, with your sampes. No time for a visit? We can hod an on-ine seminar too. Let us know what works best. PRODUCT EVALUATIONS We know that the Mitra (RUO) Microsamper sounds too good to be true. However, weõre so confident in the simpicity and performance of the device we wi et you try it out on us*. Request a FREE 96-we pate assemby to evauate in your ab. *Limit one 96-we pate evauation device per company. Free sampe subject to avaiabiity. Subject to Standard Terms and Conditions, which may be viewed at

13 RESOURCES TECHNICAL SUPPORT LITERATURE, VIDEOS, & MORE 1 TECHNICAL SUPPORT Let us put you first! Our team of technica consutants are avaiabe to provide unimited, personaized support to hep you impement Mitra (RUO) Microsamping in your ab. From sampe coection questions to extraction method deveopment hep to anaytica resut troubeshooting we are committed to getting your question answered, fast and friendy. LITERATURE, VIDEOS, & MORE This brochure hopefuy got you excited about the potentia of the Mitra (RUO) Microsamping Device to revoutionize your sampe coection and anaysis. But, we know you probaby need a itte more. Visit mitra to access product videos, peer-authored journa references, and technica iterature a about Mitra. Have Questions? Want to set up a Deminar? Get in touch with us at: mitrasaes@phenomenex.com

14 ORDERING INFORMATION Product Part No. Description Unit Typica Uses 9R-K00-CA Mitra (RUO) 10µL Microsamping Device 96-We Pate Assemby 1 ea For high-throughput environments (e.g. discovery abs) For anima studies For method deveopment 9R-K00-CD Mitra (RUO) 10µL Microsamping Device 96-We Pate Assemby 1/pk 14 For cinica trias The Mitra (RUO) Microsamping Device is guaranteed to coect a precise voume. If your Mitra Microsampers do not consistenty coect a precise voume, send in your data within 45 days for a fu refund. 9R-K00-BF Mitra (RUO) 10µL Microsamping Device 4-Pack Camshe 60/pk For direct samping For at-home samping For remote ocations AK-968-A Mitra Drying Rack 96-We Pate 1 ea To organize samping for high-throughput environments

15 Product Part No. Description Unit Typica Uses ORDERING INFORMATION AK-969-A Mitra SBS Deck Adapter 96-We Pate 1 ea For mounting 96-we pate on deck of iquid handers AK-970-A Mitra Samping Too 1 ea To easiy manipuate and transfer sampers in 96-we pate assemby 15 AH We Coection Pate ml round we with round bottom 50/pk To perform extractions prior to anaysis Terms and Conditions Subject to Standard Terms & Conditions, which may be viewed at Trademarks Mitra and VAMS are trademarks of Neoteryx LLC. is a registered trademark of, Inc. Discaimer Mitra is patent pending. 014, Inc. A rights reserved.

16 REVOLUTIONARY, YET ABSURDLY SIMPLE DRIED MATRIX MICROSAMPLING Austraia t: f: Austria t: f: Begium t: (French) t: (Dutch) f: +1 (0) beinfo@phenomenex.com Canada t: (800) f: (10) info@phenomenex.com Denmark t: f: nordicinfo@phenomenex.com Finand t: f: nordicinfo@phenomenex.com France t: f: franceinfo@phenomenex.com Germany t: f: anfrage@phenomenex.com India t: f: indiainfo@phenomenex.com Ireand t: f: eireinfo@phenomenex.com Itay t: f: itaiainfo@phenomenex.com Luxembourg t: +1 (0) f: +1 (0) ninfo@phenomenex.com Mexico t: f: tecnicomx@phenomenex.com The Netherands t: f: ninfo@phenomenex.com New Zeaand t: f: nzinfo@phenomenex.com Norway t: f: nordicinfo@phenomenex.com Puerto Rico t: (800) 541-HPLC f: (10) info@phenomenex.com Sweden t: f: nordicinfo@phenomenex.com United Kingdom t: f: ukinfo@phenomenex.com United States t: (10) f: (10) info@phenomenex.com A other countries: Corporate Office USA t: (10) f: (10) info@phenomenex.com products are avaiabe wordwide. For the distributor in your country, contact USA, Internationa Department at internationa@phenomenex.com BR70514_W 411 Madrid Avenue Torrance, CA USA PRSRT STD U.S. POSTAGE PAID TORRANCE, CA PERMIT NO. 185

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