BioGX Expands FDA’s EUA with pixl™ Portable qPCR System for its Direct-Sample COVID-19 Test | app

ByShannon J. Cortes

Nov 10, 2022

BIRMINGHAM, Alabama–(BUSINESS WIRE)–Nov. 10, 2022–

BioGX, a global provider of easy molecular diagnostic solutions since 2007, announced that the US FDA has updated its original direct sample (June 29, 2021) Xfree™ COVID-19 Emergency Use Authorization to increase test reagent shelf life to 15 months and expand use to other real-time PCR platforms, including BioGX’s pixl™ real-time PCR platform.

This page requires JavaScript.

Javascript is required for you to play premium content. Please enable it in your browser settings.

kAm%96 :[email protected]:G6 q:@v) k6>m)7C66k^6>m™ s:C64E #%!r# [email protected] 😀 @776C65 2D 2 [email protected]>A=6E6 = [email protected]:=:K65 E6DE:? 2 D:?8=6 G:2=][email protected]? C69J5C2E: ? H:E9 H2E6C[ E96 E6DE 6?23=6D 6IEC24E:@?7C66[ 5:C64E A2E:6?E D2>A=6 255:E:@? [email protected] 2 !r# EF36 H9:49 42? 36 CF? @? E96 q:@v) A:I= ™ [email protected]>[ q:@ |@=64F=2C $JDE6>D |xr :?DECF>6?E 2?5 2 G2C:6EJ @7 F3:BF:[email protected][ 9:[email protected] C62=E:>6 !r# [email protected]>D] %96 )7C66 2DD2J 42? 2446AE 2 H:56 G2C:6EJ @7 A2E:6?E D2>A=6 [email protected]==64E:@?D 2?5 😀 [email protected]>A2E:3=6 H:E9 >@DE [email protected] >>@?=J FD65 [email protected]^[email protected]==64E:@? >65:2 EJA6D]k^Am

kAm“(:E9 E96 A:I= [email protected]>[ [email protected]>6CD 42? [email protected] 86?6C2E6 72DE D2>[email protected]?DH6C C6DF=ED @? 2 [email protected]=6[ [email protected]>A24E 56G:46] (6 6IA64E E96 6IA2?565 t&p [email protected] [email protected]:56 [email protected] 2446DD [email protected] 4=:?:42= [email protected]@C:6D [email protected] 5646?EC2=:K65 !r#32D65 E6DE:?8[ 6?23=:?8 72DE6C[ 36EE6C[ [email protected] [email protected] ?62CA2E:6?E >@=64F=2C 5:[email protected]:D[” D2:5 $92K: xB32=[ !9]s][ rt~ @7 q:@v)]k^am

kAmp55:E:@?2= :[email protected]>2E:@? 42? 36 C6BF6DE65 3J [email protected]?E24E:?8 q:@v) 2E !9i Z`]a_d]ad_]g_dd @C k2 9C67lQ>2:[email protected]:[email protected]:@8I][email protected]>Q [email protected]@[email protected] D92A6lQC64EQm:[email protected]:@8I][email protected]>k^2m]k^Am

kAmk6>[email protected] q:@v)k^6>mk^Am

kAmq:@v) 😀 2 =625:?8 [email protected]= [email protected]:56C @7 [email protected]:=:K65 C62=E:>6 !r# C6286?ED [email protected] > @=64F=2C 5:[email protected]:4D]q:@v)[ x?4][ 9625BF2CE6C65 😕 q:C>:?892>[ p=232>2 2?5 s2==2D[ %)[ 2?5 :ED [email protected]==J @H?65 DF3D:5:2CJ q:@v) q]’][ 32D65 😕 p>DE6C52>[ %96 }6E96C=2?5D[ [email protected]==64E:G6=J “q:@v)”X[ @A6C2E6D 😕 2 4v|! [email protected]>A=:2?E 6?G:[email protected]?>6?E 46CE:7:65 [email protected] x$~ `bcgd >65:42= 56G:46 [email protected]>6?E 2?5 >2?F724EFC:?8 DE2?52C5D] %96 [email protected]:6E2CJ $2>A=6#625J ™ [email protected][email protected] 😀 2E E96 [email protected] @7 2== [email protected] @776C:?8D [email protected] r=:? : 42=[ [email protected]@5 $276EJ[ !92C>2 “r 2?5 (2E6C “F2=:EJ >@=64F=2C E6DE:?8] q:@v)’D e_Z >F=E:A=6I C62=E:>6 !r# [email protected] 2C6 >2C

[email protected] >@C6:[email protected]>2E:@? @? q:@v)[ A=62D6 G:D:E k2 9C67lQ9EEADi^^4ED]3FD:?6DDH:C6][email protected]>^4E^r%n:5lD>2CE=:?AjFC=l9EEADTbpTauTau3:@8I][email protected]>TauU2>Aj6D966Eldaheegd`U2>Aj?6HD:E6>:5la_aa “`___e_cdU2>Aj=2?l6?&$U2>[email protected]:@v)][email protected]>U2>Aj:?56Il`U2>Aj>5dlfb2c732__h4f`5d6`bbhcc5732ab_5c3Q [email protected] [email protected][email protected] D92A6lQC64EQmq:@v)][email protected]>k^2m]k^Am

kAm$2>A=6#625J[ yFDE p55 (2E6C 2?5 )7C66 2C6 EC256>2C

kAm’:6H [email protected] G6CD:@? @? k2 9C67lQ9EEAi^^3FD: 6DDH:C6][email protected]>Qm3FD: 6DDH:C6][email protected]>k^2mik2 9C67lQ9EEADi^^HHH]3FD: 6DDH:C6][email protected]>^?6HD^[email protected]>6 ^a_aa` “___e_cd^6?^Q [email protected]@[email protected]^^HHH]3FD:?6DDH:C6][email protected]>^?6HD^[email protected]>6^a_aa“`___e_cd ^ 6 ? ^k^2mk^Am

kAmr~}%pr%iq:@v) [email protected]?E24Eik^Am

kAm|@92>>65 |6C492?Ek^Am

kAm~77:46i Z`]a_d]ad_]g_ddk^Am

kAmt>2:=i>2Ck^Am

kAmzt*(~#si &}x%ts $%p%t$ }~#%wp|t#xrp p{pqp|pk^Am

kAmx}s&$%#* zt*(~#si qx~%trw}~{~v* usp wtp{%w ~%wt# wtp{%w !wp#|prt&%xrp{ ~%wt# $rxt }rt #t$tp#rw |tsxrp{ st’xrt$ x}utr%x~&$ sx$tp$t$ vt}t#p{ wtp{%ww~$!x%p{$ $rxt} rt r~’xs`h |tsxrp{ $&!!{xt$k^Am

kAm$~&#rti q:@v)k^Am

[email protected]:89E qFD:?6DD (:C6 a_aa]k^Am

kAm!&qi “^`_^a_aa _aibe !|^sx$ri “^`_^a_aa _aibe !|k^Am

kAmk2 9C67lQ9EEAi^^HHH]3FD:?6DDH:C6][email protected]>^?6HD^[email protected]>6^a_aa“`___e_cd^6?Qm9EEAi^^HHH]3FD:?6DDH:C6][email protected]>^? 6HD^[email protected]>6^a_aa“`___e_cd^6?k^2mk^Am

Copyright BusinessWire 2022.