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Change Order Form

Note: Fill in each box with the required information; if not applicable enter N/A.
Change rder No: !nitiator: pen "ate: Clo#e "ate
CO # 14_154 Lyndsay Radnedge 07/07/2014
$roduct%#& Affected' NIPT CS PAT PGD POC Othe!
No "ocument (itle and Number: $art No ld )e* New )e*
1 PROD"01#! NIPT $a%&dat&'n Re('t! gDNA e)ta*t&'n and gen'ty(&ng +&th
,IAG-N ,&aSy.(h'ny and I%%/.&na 0&Se1 2500 a(&d 2%'+ *e%% 2' NIPT
3Pan'a.a4
N/A Re5 2 Re5 6
)ea#on for Change Ne+ Re%ease P'd/*t 7(date P'*ess 7(date D'*/.ent 7(date
C'st Red/*t&'n Othe
+ummar, of Change:
Ta8%e 1 Re5 6 e5&sed t' e*t&2y &n*'e*t s't&ng '2 the data &n Ta8%e 1 Re529 The *'e*t data 2'
.a((ed and t'ta% eads d&d n't .at*h the sa.(%e n/.8es : a((aent%y these data +ee .&s"
s'ted &n the 'g&na% d'*/.ent9 The ent&e set '2 data 5a%/es &s *'.(%ete; and d' d' n't *hange;
thee2'e the a**e(tan*e *&te&a ae st&%% .et9
-u#tification:
The *'e*t t'ta% and .a((ed eads data ae sh'+n 2' ea*h sa.(%e9 C'e*t data +ee *'n2&.ed
&n LI<S9
)i#. A##e##ment )equired' /e# No )ef 0:
1erification or 1alidation )equired' /e# No )ef 0:
CA$A /e# No CA$A 0:
NC) /e# No NC) 0:
(raining )equired' /e# No )ef 0:
I2 yes; add e2een*e t' *'es('nd&ng d'*/.ent n/.8e ' atta*h &t t' the CO9
Authori2ation for Change rder %Appro*al&:
De(at.ent! Na.e! Date! S&gnat/e!
R=D <att 0&%%
O(s Cat <ed&na
Stats Sty.& S&g/>'nss'n
-ng&nee&ng <&?e D'dd
RA/,A Anna Ng/yen
"ate Change 3ffecti*e:
Comment# in ca#e of change order denial:
Form 4.2-1-2 Rev. 4 Page 1
of 1

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