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TOKIMUS BIOTECH BIOTECHNOLOGY SOLUTIONS FROM AROUND THE WORLD COVID-19 Test Kits for North America A BETTER ALTERNATIVE FOR COVID-19 TESTING Tokimus Biotech was founded by a group of medical experts and importers dedicated to providing fairly-priced, quality disease testing in North America. Recognizing the unmet need for fast and reliable COVID-19 testing, Tokimus is importing FDA/EUA-approved, affordable diagnostic test kits from leading, high-capacity manufacturers in South Korea. THE TOKIMUS ADVANTAGE EXPERTISE A balanced team with particular expertise in disease, medicine, U.S importing and international finance. AFFORDABILITY Fair pricing to help communities and governments manage the COVID-19 crisis. REGULATORY APPROVALS Our products are FDA approved under Section 564(c) of the Emergency Use Authorization (EUA) pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act. Tested by the National Institute of Health (NIH). The tests are legally approved for sale in the U.S. (MDEL #14182 for export into Canada) RELIABILITY ISO 13485-certified, high-capacity manufacturers known internationally for quality and reliability. CAPACITY Our distributors can produce 500,000 kits per week and can ramp up to 1,000,000 per week. COMMITMENT Exclusive Distributorship for North America. OUR PRODUCTS Polymerase Chain Reaction (PCR) Test Through throat or nasal swabs, this test detects the genetic information of the virus, or its RNA. This will exist only if the virus is there and someone is actively infected. Samples are sent to centralized labs for analysis. Generally these are the most reliable tests. Accessories include VTM/Swabs and RNA extraction kits. Two versions are available: A) AQ-TOP 30 min, single gene B) Also for U-TOP-2 hour, multi-gene, 100% accuracy. Future applications (subject to FDA approval) for use in flu/respiratory testing. The Seasun PCR test kits are approved in 11 countries. Antibody Test Our Antibody Test Kit identifies people who have previously been infected with COVID-19. This test provides a good way to track the spread of the coronavirus through a population, and it can identify people exposed to the virus but who may not have experienced symptoms. Also, once identified as having antibodies that indicate recovery, plasma from these individuals may be used to treat very ill COVID-19 patients. p .1 Antibody test from Shin Jin Medics VTM (Viral Transport Medium) swabs for the PCR tests Seasun Biomaterials’ COVID-19 RT-PCR Test Kit (Reverse Transcription - Polymerase Chain Reaction)

CO VID -19 Test Kits for N orth Am erica · 2020. 8. 14. · CO VID -19 Test Kits for N orth Am erica p.3 K EY M A N AG EM EN T Patrick Riggs President and CEO Im port/export entrepreneur

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Page 1: CO VID -19 Test Kits for N orth Am erica · 2020. 8. 14. · CO VID -19 Test Kits for N orth Am erica p.3 K EY M A N AG EM EN T Patrick Riggs President and CEO Im port/export entrepreneur

TOKIMUS BIOTECHBIOTECHNOLOGY SOLUTIONS FROM AROUND THE WORLD

C O V ID -1 9 T e s t K i t s f o r N o r t h A m e r i c a

A B E T T E R A L T E R N A T I V E F O R C O V I D -1 9 T E S T I N G

T o k im u s B io t e c h w a s fo u n d e d b y a g ro u p o f m e d ic a l e x p e r t s a n d im p o r te rs d e d ic a te d to p ro v id in g fa ir ly -p r ic e d , q u a lit y d is e a s e te s t in g in N o r th A m e r ic a . R e c o g n iz in g th e u n m e t n e e d fo r fa s t a n d re lia b le C O V ID -1 9 te s t in g , To k im u s is im p o r t in g F D A /E U A -a p p ro v e d , a ff o rd a b le d ia g n o s t ic t e s t k it s f ro m le a d in g , h ig h -c a p a c it y m a n u fa c tu re rs in S o u th K o re a .

T H E T O K I M U S A D V A N T A G E

E X P E R T I S EA b a la n c e d t e a m w it h p a r t ic u la r e x p e r t i s e in d is e a s e , m e d ic in e , U .S im p o r t in g a n d in t e r n a t io n a l fi n a n c e .

A F F O R D A B I L I T Y F a i r p r ic in g t o h e lp c o m m u n it ie s a n d g o v e r n m e n t s m a n a g e t h e C O V ID -1 9 c r i s i s .

R E G U L A T O R Y A P P R O V A L S O u r p r o d u c t s a r e F D A a p p r o v e d u n d e r S e c t io n 5 6 4 (c ) o f t h e E m e rg e n c y U s e A u t h o r iz a t io n (E U A ) p u r s u a n t t o S e c t io n 5 6 4 o f t h e F e d e r a l F o o d , D r u g , a n d C o sm e t ic A c t . T e s t e d b y t h e N a t io n a l In s t i t u t e o f H e a lt h (N IH ). T h e t e s t s a r e le g a l ly a p p r o v e d fo r s a le in t h e U .S . (M D E L # 1 4 1 8 2 fo r e x p o r t in t o C a n a d a )

R E L I A B I L I T Y IS O 1 3 4 8 5 -c e r t ifi e d , h ig h -c a p a c it y m a n u fa c t u re r s k n o w n in t e r n a t io n a l ly f o r q u a l i t y a n d r e l ia b i l i t y .

C A P A C I T Y O u r d is t r ib u t o r s c a n p r o d u c e 5 0 0 ,0 0 0 k i t s p e r w e e k a n d c a n r a m p u p t o 1 ,0 0 0 ,0 0 0 p e r w e e k .

C O M M I T M E N T E x c lu s iv e D is t r ib u t o r s h ip f o r N o r t h A m e r ic a .

O U R P R O D U C T S

P o ly m e r a s e C h a i n R e a c t i o n (P C R ) T e s t T h ro u g h th ro a t o r n a s a l sw a b s , t h is t e s t d e te c t s t h e g e n e t ic in fo rm a t io n o f t h e v iru s , o r it s R N A . T h is w ill e x is t o n ly if t h e v iru s is t h e re a n d s o m e o n e is a c t iv e ly in fe c te d . S am p le s a re s e n t to c e n t ra liz e d la b s fo r a n a ly s is . G e n e ra lly t h e s e a re t h e m o s t re lia b le t e s t s . A c c e s s o r ie s in c lu d e V TM /Sw a b s a n d R N A e x t ra c t io n k it s . Tw o v e rs io n s a re a v a ila b le :A ) A Q -TO P 3 0 m in , s in g le g e n e B ) A ls o fo r U -TO P -2 h o u r, m u lt i-g e n e , 1 0 0% a c c u ra c y. Fu tu re a p p lic a t io n s (su b je c t to F D A a p p ro v a l) fo r u se in flu /re sp ira to ry t e s t in g . T h e S e a s u n P C R te s t k it s a re a p p ro v e d in 1 1 c o u n t r ie s .

A n t i b o d y T e s t O u r A n t ib o d y Te s t K it id e n t ifi e s p e o p le w h o h a v e p re v io u s ly b e e n in fe c te d w ith C O V ID -1 9 . T h is t e s t p ro v id e s a g o o d w a y to t ra c k th e s p re a d o f t h e c o ro n a v iru s t h ro u g h a p o p u la t io n , a n d it c a n id e n t ify p e o p le e x p o s e d to th e v iru s b u t w h o m a y n o t h a v e e x p e r ie n c e d s ym p to m s . A ls o , o n c e id e n t ifi e d a s h a v in g a n t ib o d ie s t h a t in d ic a te re c o v e r y , p la sm a f ro m th e s e in d iv id u a ls m a y b e u s e d to t re a t v e r y ill C O V ID -1 9 p a t ie n t s .

p .1

A n t ib o d y t e s t f ro m S h in J in M e d ic s

V T M (V ira l T ra n s p o r t M e d iu m ) sw a b s fo r t h e P C R t e s t s

S e a s u n B io m a te r ia ls ’ C O V ID -1 9 R T -P C R Te s t K it (R e v e r s e T ra n s c r ip t io n - P o ly m e ra s e C h a in R e a c t io n )

Page 2: CO VID -19 Test Kits for N orth Am erica · 2020. 8. 14. · CO VID -19 Test Kits for N orth Am erica p.3 K EY M A N AG EM EN T Patrick Riggs President and CEO Im port/export entrepreneur

p . 2

O U R S U P P L I E R S

S e a s u n B i o m a t e r i a l sO p e ra t in g s in c e 2 0 1 2 , S e a s u n B io m a te r ia ls o f D a e je o n , S o u th K o re a is a n in v it ro d ia g n o s t ic c o m p a n y th a t d e v e lo p s m o le c u la r d ia g n o s t ic p la t fo rm s fo r in fe c t io u s d is e a s e s , c a n c e r a n d g e n e t ic a n d e p ig e n e t ic d is o rd e rs . T h e y h o ld a lic e n s e o f M e d ic a l D e v ic e M a n u fa c tu r in g g ra n te d b y th e K o re a n M in is t r y o f F o o d a n d D ru g S a fe t y a n d a re c e r t ifi e d b y th e U S C e n te rs fo r D is e a s e C o n t ro l a s a D N A te s t in g in s t it u t io n . F o r C O V ID -1 9 S e a s u n o ff e rs V iru s C o lle c t io n K it s , T O P TM V ira l D N A /R N A E x t ra c t io n K it s , A Q T O P TM C O V ID 1 9 D e te c t io n K it s a n d U T O P TM C O V ID 1 9 D e te c t io n K it s . T h e S e a s u n U T O P TM K it s w e re h ig h ly ra te d in a t h ird p a r t y b lin d s tu d y b y th e F D A . T h e m a n u fa c tu r in g fa c ilit y is IS O 1 3 4 8 5 c e r t ifi e d a n d th e c o m p a n y h o ld s a G o o d M a n u fa c tu r in g P ra c t ic e (G M P ) c e r t ifi c a te . F o r m o r e in fo rm a t io n v is i t w w w .s e a s u n b io .c o m

S h i n J i n M e d i c s I n c . In e x is te n c e s in c e 1 9 9 2 , S h in J in d e v e lo p s a n d m a n u fa c tu re s a w id e ra n g e o f d ia g n o s t ic k it s a n d in s t ru m e n t s a n d h a s b e c o m e a g lo b a l le a d e r fo r im m u n o d ia g n o s t ic (in c lu d in g C O V ID -1 9 a n t ib o d y te s t s ) a n d life s c ie n c e t e c h n o lo g y . S h in J in M e d ic s is a u th o r iz e d to s e ll it s C O V ID -1 9 A n t ib o d y te s t in g k it in t h e U n ite d S t a te s v ia t h e E m e rg e n c y U s e A u th o r iz a t io n (E U A ) b y th e U S F o o d a n d D ru g A d m in is t ra t io n a n d , is in p ro c e s s v ia a p p lic a t io n in C a n a d a fo r re g u la to r y c le a ra n c e s th e re , v ia H e a lth C a n a d a . T h e y a re k n o w n fo r t h e h ig h e s t q u a lit y d ia g n o s t ic re a g e n t s a n d in s t ru m e n t s . F D A -E U A p e r N o t ifi c a t io n . F o r m o r e in fo rm a t io n v is i t w w w .d ia k e y .c o m /h o m e p a g e

R a p iG E N I n c .B a s e d in G y e o n g g i-d o , R e p u b lic o f K o re a , R a p iG E N In c . h a s d e v e lo p e d a n d s u p p lie d a d v a n c e d d is e a s e te s t in g te c h n o lo g y w o r ld w id e s in c e 2 0 0 2 . R a p iG E N ’s B io c re d it S A R S C o V 2 A n t ig e n te s t re p re s e n t s t h e w o r ld ’s fi rs t c o m m e rc ia liz a t io n o f B la c k G o ld Pa r t ic le te c h n o lo g y (h ig h se n s it iv it y a n d sp e c ifi c ity ). T h e te s t m e a su re s a n t ig e n s (if t h e p a t ie n t is in fe c t io u s ) a n d b o a s t s h ig h s e n s it iv it y /s p e c ifi c it y , s im p lic it y a n d ra p id t e s t t im e tu rn a ro u n d (5 - 8 m in u te s ). F D A -E U A is a p p lie d fo r a n d p e n d in g . F o r m o r e in fo rm a t io n v is i t w w w .ra p ig e n -in c .c o m

G e n e S o lu t i o n C o . L t dF o u n d e d in 2 0 1 9 , G e n e S o lu t io n is a g lo b a l b io te c h n o lo g y c o m p a n y b a s e d in In c h e o n , S o u th K o re a . T h e c o m p a n y h a s e m e rg e d ra p id ly a s a le a d in g , in te rn a t io n a l su p p lie r o f C O V ID -1 9 sam p le c o lle c t io n k its . F o r m o re in fo rm a t io n v is it h t tp s ://g e n e s o lu t io n .w ix s it e .c o m /w e b s ite ? la n g =e n

C O V ID -1 9 T e s t K i t s f o r N o r t h A m e r i c a

t o k im u s b io t e c h .c o m

Page 3: CO VID -19 Test Kits for N orth Am erica · 2020. 8. 14. · CO VID -19 Test Kits for N orth Am erica p.3 K EY M A N AG EM EN T Patrick Riggs President and CEO Im port/export entrepreneur

C O V ID -1 9 T e s t K i t s f o r N o r t h A m e r i c a

p . 3

K E Y M A N A G E M E N T

P a t r i c k R i g g s P re s id e n t a n d C E OIm p o r t /e x p o r t e n t re p re n e u r a n d fi n a n c ie r fo r o v e r 1 5 y e a rs a n d a fi n a n c e c o n su lta n t a n d s t ra te g y a d v is o r to m id d le m a rk e t c o m p a n ie s . A s Im p o r t m a n a g e r fo r a n in te rn a t io n a l t ra d in g c o m p a n y , h e d e v e lo p e d lo n g te rm re la t io n s h ip s w ith k e y A s ia n t ra d in g p a r tn e rs , w h ic h le d to th e s u p p lie r re la t io n s h ip s n o w b e n e fi t in g To k im u s B io te c h . P a t a t te n d e d U n iv e rs it y o f N o r th D a k o ta in 1 9 9 0 a n d c o m p le te d a n in d e p e n d e n t s tu d y p ro g ram re c e iv in g u n iv e rs it y c re d it s a t H a r v a rd B u s in e s s S c h o o l in 2 0 1 9 .

J a s o n L i u C PA , M BAC F O

B o rn in Ta iw a n , J a s o n re c e iv e d h is a c c o u n t in g d e g re e f ro m A le th e ia U n iv e rs it y in Ta iw a n , t h e n c o m p le te d h is M B A a t t h e U n iv e rs it y o f H o u s to n . D u e to h is c o n t in u e d t ie s to Ta iw a n a n d A s ia , J a s o n p ro v id e s v a lu a b le in s ig h t s in to th e b u s in e s s c u ltu re o f S E A s ia a s w e ll a s p ro v id in g m a n y c o n ta c t s . In h is c a re e r h e h a s b e e n in s tru m e n ta l in fin a n c in g b o th U S a n d fo re ig n e n tre p re n e u ria l c o m p an ie s .

G e r v a i s e W i lh e lm B S , (M e d ic a l Te c h n o lo g y ) M B A , M L S , PA (c a rd io v a s c u la r s u rg e r y ), R e g u la to r y a n d P ro d u c t A d v is o r

In a d d it io n to fo rm a l t ra in in g a n d s e v e ra l y e a rs ’ e x p e r ie n c e a s a la b o ra to r y s c ie n t is t , M s . W ilh le m is a v e te ra n fo u n d e r, d ire c to r a n d o ffi c e r o f fi v e life s c ie n c e c o m p a n ie s . In t h a t c a p a c it y s h e h ire d k e y e m p lo y e e s , e n g a g e d a n d in te ra c te d w ith le g a l a n d fi n a n c ia l c o n s u lt a n t s , g e n e ra te d in v e s tm e n t c a p it a l, in te ra c te d w ith th e b o a rd s o f d ire c to rs a n d a c t iv e ly p a r t ic ip a te d in m a rk e t in g e ff o r t s in a d d it io n to m a n a g in g d a y -to -d a y a ff a ir s .

M a r y B e t h H e n d e r s o n B S , M S a n d P h D (C h e m is t r y )J o in e d To k im u s a s C o n s u lt a n t fo r R e g u la to r y A ff a ir s a n d Q u a lit y S y s te m s . D r. H e n d e rs o n w o rk e d fo r m o re th a n 2 5 y e a rs w ith m e d ic a l d e v ic e a n d b io te c h n o lo g y c o m p a n ie s d e v e lo p in g re g u la to r y s t ra te g y a n d q u a lit y s y s te m s d e v e lo p m e n t in c o n fo rm it y w ith d o m e s t ic a n d in te rn a t io n a l re g u la t io n s . A s V ic e P re s id e n t o f R e g u la to r y A ff a ir s a n d Q u a lit y S y s te m s a t o n e o f t h e la rg e s t re g u la to r y c o n s u lt in g fi rm s in t h e n a t io n , M a r y w o rk e d w ith c lie n t s to d e v e lo p d o m e s t ic a n d in te rn a t io n a l re g u la to r y s t ra te g ie s a n d n e g o t ia te d s u c c e s s fu lly w ith th e F D A fo r p ro d u c t a p p ro v a ls .

D r . D a r r e l l Y . C a ld e r o n M D , FA C E P, M e d ic a l A d v is o rD r. C a ld e ro n , w h o is C O L A c e r t ifi e d , p ro v id e s c ru c ia l d ire c t io n a n d c o n su lta t io n fo r p a t ie n t t e s t in g s e r v ic e s , b a c k e d b y h is e x p e r t is e w ith m e d ic a l s t a ff , la b p e rs o n n e l a n d h o s p it a l v e n d o r m a t te rs . D r. C a ld e ro n is c u r re n t ly C h ie f M e d ic a l O ffi c e r fo r t h e H o u s to n M a rk e t a n d D ire c to r o f t h e E m e rg e n c y D e p a r tm e n t fo r F ir s t Te x a s H o s p it a l C y F a ir.

T o k im u s B i o t e c h , I n c . 1 2 G r e e n w a y P la z a S u i t e 1 1 0 0 H o u s t o n , T X 7 7 0 4 6

T 6 1 2 .8 5 0 .5 0 2 9 p a t r ig g s@ t o k im u s b io t e c h .c o m

“W e ’v e fo c u se d o u r su p p ly c h a in o n S o u th K o re a b e c a u se th e ir q u a lit y is e x c e p t io n a l a n d th e ir p r ic in g is fa ir.”

P a t r i c k R i g g s , P re s id e n t a n d C E O

t o k im u s b io t e c h .c o m

“T h e e v id e n c e m a ke s c le a r it is t im e fo r a p a ra d ig m sh if t o n te s t in g . It is t im e fo r th e fe d e ra l g o v e rn m e n t to ta k e s t ro n g le a d e rsh ip o n d ire c t in g o u r re so u rc e s to w a rd th is n ew (fre q u e n t te s t in g ) s t ra te g y.”

D r . A s h i s h K . J h a , Fa c u lt y D ire c to r o f th e H a r v a rd G lo b a l H e a lth In s t itu te