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Subject: =?utf-8?Q?Reminder=3A=20Flow=20cytometric=20gene=20mutation=20assay=2C=20made=20possible=20by=20immunomagnetic=20separation=2C=20achieves=20OECD=20regulatory=20status?=
From: =?utf-8?Q?Labroots=20for=20Miltenyi=20Biotec?= <info@labroots.com>
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Date: Mon, 31 Oct 2022 16:31:08 +0000
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Free Webinar - Register Today!=C2=A0

View this email in your browser (https://mailchi.mp/labroots/achieving-cli=
nical-quality-for-human-ipsc-generation-and-expansion-227994?e=3D34b99a6f1e)
https://www.labroots.com/ms/webinar/flow-cytometric-gene-mutation-assay-im=
munomagnetic-separation-achieves-oecd-regulatory-status?campaign=3Dlremail
Register for Free (https://www.labroots.com/ms/webinar/flow-cytometric-gen=
e-mutation-assay-immunomagnetic-separation-achieves-oecd-regulatory-status=
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**
Flow cytometric gene mutation assay=2C made possible by immunomagnetic sep=
aration=2C achieves OECD regulatory status
------------------------------------------------------------

November 01=2C 2022
https://www.labroots.com/intercall/add-to-calendar/Webinar/7640?start-date=
=3D20221101T100000&end-date=3D20221101T110000&TZID=3DAmerica/Los_Angeles10=
:00am (PDT)=2C 1:00pm (EDT)=2C
6:00pm (CET)
Presented by:
https://www.labroots.com/ms/webinar/flow-cytometric-gene-mutation-assay-im=
munomagnetic-separation-achieves-oecd-regulatory-status?campaign=3Dlremail
Jeffrey Bemis=2C Ph.D.
Director of Clinical Studies=2C Litron Laboratories

https://www.labroots.com/ms/webinar/flow-cytometric-gene-mutation-assay-im=
munomagnetic-separation-achieves-oecd-regulatory-status?campaign=3Dlremail
Joe Ostrand=2C Ph.D.
Flow Cytometry Specialist=2C
Miltenyi Biotec

=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=
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=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D

Abstract:
Litron laboratories developed the Pig-a gene mutation assay as a means to=
 simply and reliably evaluate the potential mutagenicity of compounds. Com=
mercially available from Litron Laboratories under the name MutaFlow=2C th=
is method utilizes the endogenous phosphatidylinositol glycan class A gene=
 found in most mammalian species as a reporter of gene mutation. During ea=
rly development=2C the assay was challenged by the rare event nature of th=
is analysis and the time and effort required to interrogate a sufficient n=
umber of events in order to reliably calculate a mutation frequency in per=
ipheral red blood cells. Following the addition of labeling of cells with=
 superparamagnetic beads and the use of immunomagnetic columns to focus an=
alysis on the cells of interest=2C the sample throughput and number of eve=
nts scored was dramatically increased.

This critical improvement facilitated the continued development and commer=
cialization of the assay into a successful line of kits and services. Subs=
equent to additional work by Litron and others=2C the validation of the as=
say was deemed sufficient to submit for regulatory approval in the form of=
 Test Guideline development by the Organization of Economic Cooperation an=
d Development (OECD). The formal =E2=80=9CTest Guideline 470 Mammalian Ery=
throcyte Pig-a Gene Mutation Assay=E2=80=9D was adopted in June of this ye=
ar and serves to establish the assay as applicable for regulatory safety s=
ubmissions.

Learning Objectives
* The MutaFlow Assay is an endogenous gene mutation assay that can be read=
ily integrated with existing animal studies performed for product safety a=
ssessment
* The ability to focus analysis on the rare mutation phenotype is made pos=
sible by the combination of immunomagnetic separation and flow cytometry
* The Pig-a assay is now supported by an OECD Test Guideline (TG470) to fa=
cilitate use under GLP in support of regulatory submissions

** Register now (https://www.labroots.com/ms/webinar/flow-cytometric-gene-=
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00%" class=3D"mcnTextBlock" style=3D"min-width: 100%;border-collapse: coll=
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g-top: 9px;mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-webki=
t-text-size-adjust: 100%;">
              =09
=09=09=09
=09=09=09=09
                <table align=3D"left" border=3D"0" cellpadding=3D"0" cells=
pacing=3D"0" style=3D"max-width: 100%;min-width: 100%;border-collapse: col=
lapse;mso-table-lspace: 0pt;mso-table-rspace: 0pt;-ms-text-size-adjust: 10=
0%;-webkit-text-size-adjust: 100%;" width=3D"100%" class=3D"mcnTextContent=
Container">
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<h1 style=3D"display: block;margin: 0;padding:=
 0;color: #333333;font-family: Helvetica;font-size: 24px;font-style: norma=
l;font-weight: normal;line-height: 125%;letter-spacing: normal;text-align:=
 left;"><br>
<span style=3D"font-size:27px">Flow cytometric gene mutation assay=2C made=
 possible by immunomagnetic separation=2C achieves OECD regulatory status<=
/span></h1>

<p style=3D"text-align: left;margin: 10px 0;padding: 0;mso-line-height-rul=
e: exactly;-ms-text-size-adjust: 100%;-webkit-text-size-adjust: 100%;color=
: #202020;font-family: Helvetica;font-size: 14px;line-height: 150%;"><br>
<span style=3D"font-size:15px"><span style=3D"color:#FF7D00"><strong>Novem=
ber 01=2C 2022</strong></span><br>
<a href=3D"https://labroots.us7.list-manage.com/track/click?u=3D6f39393ef3=
8fb324428ff8c2c&id=3D09fd9f016b&e=3D34b99a6f1e" target=3D"_blank" style=
=3D"mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-webkit-text-=
size-adjust: 100%;color: #1e8ae7;font-weight: normal;text-decoration: unde=
rline;"><img data-file-id=3D"42943" height=3D"13" src=3D"https://gallery.m=
ailchimp.com/6f39393ef38fb324428ff8c2c/images/b9d0b3b5-66ac-4b86-857f-08e5=
d0e67a46.png" style=3D"border: 0px;width: 20px;height: 13px;margin: 0px;ou=
tline: none;text-decoration: none;-ms-interpolation-mode: bicubic;" width=
=3D"20"></a>10:00am (PDT)=2C 1:00pm (EDT)=2C<br>
&nbsp; &nbsp; &nbsp;6:00pm (CET)</span></p>

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=09=09=09=09

=09=09=09=09
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lpadding=3D"0" cellspacing=3D"0" width=3D"300" class=3D"columnWrapper" sty=
le=3D"border-collapse: collapse;mso-table-lspace: 0pt;mso-table-rspace: 0p=
t;-ms-text-size-adjust: 100%;-webkit-text-size-adjust: 100%;">
                                        <tr>
                                            <td valign=3D"top" class=3D"co=
lumnContainer" style=3D"mso-line-height-rule: exactly;-ms-text-size-adjust=
: 100%;-webkit-text-size-adjust: 100%;"><table border=3D"0" cellpadding=3D=
"0" cellspacing=3D"0" width=3D"100%" class=3D"mcnTextBlock" style=3D"min-w=
idth: 100%;border-collapse: collapse;mso-table-lspace: 0pt;mso-table-rspac=
e: 0pt;-ms-text-size-adjust: 100%;-webkit-text-size-adjust: 100%;">
    <tbody class=3D"mcnTextBlockOuter">
        <tr>
            <td valign=3D"top" class=3D"mcnTextBlockInner" style=3D"paddin=
g-top: 9px;mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-webki=
t-text-size-adjust: 100%;">
              =09
=09=09=09
=09=09=09=09
                <table align=3D"left" border=3D"0" cellpadding=3D"0" cells=
pacing=3D"0" style=3D"max-width: 100%;min-width: 100%;border-collapse: col=
lapse;mso-table-lspace: 0pt;mso-table-rspace: 0pt;-ms-text-size-adjust: 10=
0%;-webkit-text-size-adjust: 100%;" width=3D"100%" class=3D"mcnTextContent=
Container">
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<strong>Presented by:</strong>
                        </td>
                    </tr>
                </tbody></table>
=09=09=09=09

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</table><table border=3D"0" cellpadding=3D"0" cellspacing=3D"0" width=3D"1=
00%" class=3D"mcnTextBlock" style=3D"min-width: 100%;border-collapse: coll=
apse;mso-table-lspace: 0pt;mso-table-rspace: 0pt;-ms-text-size-adjust: 100=
%;-webkit-text-size-adjust: 100%;">
    <tbody class=3D"mcnTextBlockOuter">
        <tr>
            <td valign=3D"top" class=3D"mcnTextBlockInner" style=3D"paddin=
g-top: 9px;mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-webki=
t-text-size-adjust: 100%;">
              =09
=09=09=09
=09=09=09=09
                <table align=3D"left" border=3D"0" cellpadding=3D"0" cells=
pacing=3D"0" style=3D"max-width: 100%;min-width: 100%;border-collapse: col=
lapse;mso-table-lspace: 0pt;mso-table-rspace: 0pt;-ms-text-size-adjust: 10=
0%;-webkit-text-size-adjust: 100%;" width=3D"100%" class=3D"mcnTextContent=
Container">
                    <tbody><tr>

</td>
                    </tr>
                </tbody></table>
=09=09=09=09

</td>
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=09=09=09=09

=09=09=09=09
            </td>
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    </tbody>
</table></td>
                                        </tr>
                                    </table>
                                    
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                            </tr>
                            <tr>
                                <td valign=3D"top" id=3D"templateFooter" s=
tyle=3D"background:#ffffff none no-repeat center/cover;mso-line-height-rul=
e: exactly;-ms-text-size-adjust: 100%;-webkit-text-size-adjust: 100%;backg=
round-color: #ffffff;background-image: none;background-repeat: no-repeat;b=
ackground-position: center;background-size: cover;border-top: 0;border-bot=
tom: 0;padding-top: 9px;padding-bottom: 9px;"><table border=3D"0" cellpadd=
ing=3D"0" cellspacing=3D"0" width=3D"100%" class=3D"mcnTextBlock" style=3D=
"min-width: 100%;border-collapse: collapse;mso-table-lspace: 0pt;mso-table=
-rspace: 0pt;-ms-text-size-adjust: 100%;-webkit-text-size-adjust: 100%;">
    <tbody class=3D"mcnTextBlockOuter">
        <tr>
            <td valign=3D"top" class=3D"mcnTextBlockInner" style=3D"paddin=
g-top: 9px;mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-webki=
t-text-size-adjust: 100%;">
              =09
=09=09=09
=09=09=09=09
                <table align=3D"left" border=3D"0" cellpadding=3D"0" cells=
pacing=3D"0" style=3D"max-width: 100%;min-width: 100%;border-collapse: col=
lapse;mso-table-lspace: 0pt;mso-table-rspace: 0pt;-ms-text-size-adjust: 10=
0%;-webkit-text-size-adjust: 100%;" width=3D"100%" class=3D"mcnTextContent=
Container">
                    <tbody><tr>

<p style=3D"font-size: 14px;text-align: left;m=
argin: 10px 0;padding: 0;mso-line-height-rule: exactly;-ms-text-size-adjus=
t: 100%;-webkit-text-size-adjust: 100%;color: #555555;font-family: Helveti=
ca;line-height: 150%;"><strong>Abstract:</strong></p>
Litron laboratories&nbsp;developed the&nbsp;<em>Pig-a</em>&nbsp;gene mutat=
ion assay as a means to simply and reliably evaluate the potential mutagen=
icity of compounds. Commercially available from Litron Laboratories under=
 the name MutaFlow=2C this method utilizes the endogenous phosphatidylinos=
itol glycan class A gene found in most mammalian species as a reporter of=
 gene mutation. During early development=2C the assay was challenged by th=
e rare event nature of this analysis and the time and effort required to i=
nterrogate a sufficient number of events in order to reliably calculate a=
 mutation frequency in peripheral red blood cells. Following the addition=
 of labeling of cells with superparamagnetic beads and the use of immunoma=
gnetic columns to focus analysis on the cells of interest=2C the sample th=
roughput and number of events scored was dramatically increased.<br>
&nbsp;<br>
This critical improvement facilitated the continued development and commer=
cialization of the assay into a successful line of kits and services. Subs=
equent to additional work by Litron and others=2C the validation of the as=
say was deemed sufficient to submit for regulatory approval in the form of=
 Test Guideline development by the Organization of Economic Cooperation an=
d Development (OECD). The formal =E2=80=9CTest Guideline 470 Mammalian Ery=
throcyte&nbsp;<em>Pig-a</em>&nbsp;Gene Mutation Assay=E2=80=9D was adopted=
 in June of this year and serves to establish the assay as applicable for=
 regulatory safety submissions.<br>
<strong>&nbsp;<br>
Learning Objectives</strong>

<ul>
=09<li style=3D"mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-=
webkit-text-size-adjust: 100%;">The MutaFlow Assay is an endogenous gene m=
utation assay that can be readily integrated with existing animal studies=
 performed for product safety assessment</li>
=09<li style=3D"mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-=
webkit-text-size-adjust: 100%;">The ability to focus analysis on the rare=
 mutation phenotype is made possible by the combination of immunomagnetic=
 separation and flow cytometry</li>
=09<li style=3D"mso-line-height-rule: exactly;-ms-text-size-adjust: 100%;-=
webkit-text-size-adjust: 100%;">The&nbsp;<em>Pig-a</em>&nbsp;assay is now=
 supported by an OECD Test Guideline (TG470) to facilitate use under GLP i=
n support of regulatory submissions</li>
</ul>

</td>
                    </tr>
                </tbody></table>
=09=09=09=09

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it-text-size-adjust: 100%;">
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=3D"padding-right: 9px;padding-bottom: 9px;mso-line-height-rule: exactly;-=
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e-adjust: 100%;-webkit-text-size-adjust: 100%;">
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it-text-size-adjust: 100%;">
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eet</a>
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e-adjust: 100%;-webkit-text-size-adjust: 100%;">
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