This com­pa­ny has spent a decade in­no­vat­ing NGS-based com­pan­ion di­ag­nos­tics world­wide–what’s next?

Re­mark­able ad­vances in pre­ci­sion on­col­o­gy have re­shaped can­cer treat­ment, of­fer­ing life-chang­ing ther­a­pies to pa­tients with lim­it­ed op­tions. These ad­vances re­quire pow­er­ful tech­nolo­gies that gen­er­ate bi­o­log­i­cal da­ta, trans­late com­plex bio­mark­er da­ta, and in­te­grate eas­i­ly with clin­i­cal care—ul­ti­mate­ly help­ing im­prove out­comes for pa­tients across a wide range of tu­mor types. Few tech­nolo­gies have shaped the progress in pre­ci­sion on­col­o­gy as sig­nif­i­cant­ly as next-gen­er­a­tion se­quenc­ing (NGS), which has trans­formed bio­mark­er test­ing from sin­gle-gene tests in­to broad ge­nom­ic pro­fil­ing that can si­mul­ta­ne­ous­ly as­sess hun­dreds of bio­mark­ers, en­abling more pre­cise and per­son­al­ized treat­ment strate­gies across a broad range of can­cers.

Over the past decade, Ther­mo Fish­er Sci­en­tif­ic has helped shape the role of NGS in on­col­o­gy, by col­lab­o­rat­ing with phar­ma com­pa­nies, clin­i­cians, and reg­u­la­to­ry agen­cies to de­vel­op scal­able test­ing so­lu­tions that help ex­pand ac­cess to pre­ci­sion med­i­cine for more pa­tients.

A decade of in­no­va­tions and im­pact

Over­com­ing ob­sta­cles to en­able pre­ci­sion med­i­cine

The im­pact of NGS on pre­ci­sion med­i­cine stems not on­ly from sci­en­tif­ic in­no­va­tion, but from ad­vanc­ing tech­nolo­gies that help over­come re­al-world bar­ri­ers. While sci­en­tif­ic break­throughs with NGS en­ables deep ge­nom­ic in­sights, its true trans­for­ma­tive pow­er lies in the prac­ti­cal ap­pli­ca­tion that have made this tech­nol­o­gy ac­ces­si­ble, scal­able, and clin­i­cal­ly ac­tion­able.

Rather than fo­cus­ing sole­ly on dis­cov­ery, tech­nolo­gies that make se­quenc­ing faster, more af­ford­able, and more ac­ces­si­ble across di­verse health­care set­tings are cru­cial. They bet­ter en­able clin­i­cians to tai­lor care to in­di­vid­ual pa­tients—no mat­ter where they are.

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This shift is crit­i­cal. One of the per­sis­tent chal­lenges in CDx de­vel­op­ment is lim­it­ed tis­sue avail­abil­i­ty dur­ing clin­i­cal tri­als. De­cen­tral­ized NGS so­lu­tions can pre­serve valu­able sam­ples by en­able lo­cal test­ing, re­duc­ing turn­around times, and mit­i­gat­ing sam­ple loss. Ad­di­tion­al­ly, op­ti­miz­ing sam­ple prepa­ra­tion chem­istry al­low for ro­bust per­for­mance, even with low nu­cle­ic acid in­put, mean­ing more pa­tients can be test­ed—broad­en­ing el­i­gi­bil­i­ty and re­duc­ing bar­ri­ers to ac­cess.

A piv­otal mo­ment came with the launch of the Ion Tor­rent™ On­comine™ Dx Tar­get Test—the first FDA-ap­proved dis­trib­utable NGS-based CDx test¹. Since 2017, the test has ex­pand­ed its in­di­ca­tions for ad­di­tion­al bio­mark­ers and ther­a­pies, and is now re­im­bursed in 19 coun­tries, reach­ing over 550 mil­lion lives glob­al­ly².

By com­bin­ing ad­vances in NGS tech­nol­o­gy with close col­lab­o­ra­tions with phar­ma­ceu­ti­cal de­vel­op­ers and reg­u­la­to­ry agen­cies, pre­ci­sion on­col­o­gy is be­com­ing more scal­able and ac­ces­si­ble than ever be­fore.

Part­ner­ships pow­er progress

The evo­lu­tion of pre­ci­sion on­col­o­gy is not dri­ven by tech­nol­o­gy alone—it’s the re­sult of strate­gic, sus­tained col­lab­o­ra­tions across the health­care ecosys­tem. Col­lab­o­ra­tions with reg­u­la­to­ry agen­cies and part­ner­ships with phar­ma­ceu­ti­cal in­no­va­tors are es­sen­tial to ad­vanc­ing com­pan­ion di­ag­nos­tics and bring­ing tar­get­ed ther­a­pies to mar­ket ef­fi­cient and glob­al­ly.

With 14 ac­tive phar­ma col­lab­o­ra­tions, to­day’s ef­forts build on years of co-de­vel­op­ment ex­pe­ri­ence, from ear­ly tri­al in­te­gra­tion to glob­al reg­u­la­to­ry ap­provals and com­mer­cial­iza­tion². These col­lab­o­ra­tions are ev­i­dence of a mod­el that works: one that aligns di­ag­nos­tic de­vel­op­ment with ther­a­peu­tic in­no­va­tion to ac­cel­er­ate time­lines, im­prove ef­fi­cien­cy, and ul­ti­mate­ly bring ther­a­pies to pa­tients.

It’s this co­or­di­nat­ed ap­proach that helps en­sure in­no­va­tions in ge­nomics trans­late in­to re­al-world so­lu­tions—trans­form­ing how can­cer is di­ag­nosed, treat­ed, and man­aged world­wide.

The next decade: bring­ing pre­ci­sion on­col­o­gy clos­er to pa­tients

This re­flects more than a tech­no­log­i­cal mile­stone—it rep­re­sents the cul­mi­na­tion of over a decade of fo­cused in­no­va­tion in NGS-based CDx. What be­gan as an ef­fort to de­vel­op a CDx for non-small cell lung can­cer (NSCLC), has ma­tured in­to a glob­al­ly scal­able mod­el across mul­ti­ple can­cer types³.

By unit­ing ge­nom­ic in­no­va­tion with scal­able in­fra­struc­ture, pre­ci­sion on­col­o­gy is be­ing reimag­ined—ex­pand­ing its reach across clin­i­cal set­tings and ge­o­gra­phies. The in­tro­duc­tion of de­cen­tral­ized so­lu­tions like the Ion Tor­rent™ On­comine™ Dx Ex­press Test, built on the Ion Tor­rent™ Genexus Dx Sys­tem, marks a new era. With end-to-end au­toma­tion and the abil­i­ty to de­liv­er clin­i­cal­ly rel­e­vant NGS re­sults in as lit­tle as 24 hours from tis­sue or liq­uid biop­sy, the bar­ri­ers be­tween test­ing and treat­ment de­ci­sion mak­ing are be­ing fur­ther re­duced.

These ad­vance­ments sig­nal what the next decade holds: faster, more ef­fi­cient di­ag­nos­tics that in­te­grate in­to rou­tine care—bring­ing test­ing clos­er to pa­tients and en­abling more time­ly, per­son­al­ized treat­ment de­ci­sions. What once rep­re­sent­ed cut­ting-edge in­no­va­tion is now be­com­ing part of rou­tine care. With a decade of progress as the foun­da­tion, the path for­ward is clear: ex­pand­ing glob­al ac­cess to pre­ci­sion on­col­o­gy by de­liv­er­ing faster, more per­son­al­ized in­sights that em­pow­er physi­cians and help im­prove out­comes for pa­tients.

Ref­er­ences:

1. U.S. Food and Drug Ad­min­is­tra­tion. List of Cleared or Ap­proved Com­pan­ion Di­ag­nos­tic De­vices (In Vit­ro and Imag­ing Tools). Ac­cessed May 28, 2025. https://www.fda.gov/med­ical-de­vices/in-vit­ro-di­ag­nos­tics/list-cleared-or-ap­proved-com­pan­ion-di­ag­nos­tic-de­vices-in-vit­ro-and-imag­ing-tools.

2. Ther­mo Fish­er Sci­en­tif­ic, Com­pan­ion Di­ag­nos­tics. Ac­cessed May 28, 2025. https://www.ther­mofish­er.com/us/en/home/clin­i­cal/di­ag­nos­tic-de­vel­op­ment/com­pan­ion-di­ag­nos­tics.html.

3. Pfiz­er Inc. Ther­mo Fish­er Sci­en­tif­ic Signs De­vel­op­ment Agree­ment for Next-Gen­er­a­tion Se­quenc­ing-Based Com­pan­ion Di­ag­nos­tic. Press re­lease, No­vem­ber 18, 2015. Ac­cessed May 28, 2025. https://www.pfiz­er.com/news/press-re­lease/press-re­lease-de­tail/ther­mo-fish­er-sci­en­tif­ic-signs-de­vel­op­ment-agree­ment-next

On­comine Dx Tar­get Test: For In Vit­ro Di­ag­nos­tic Use. On­comine Dx Ex­press Test: For In Vit­ro Di­ag­nos­tic Use. Not avail­able in all coun­tries, in­clud­ing the Unit­ed States.

The On­comine Dx Tar­get Test is a qual­i­ta­tive in vit­ro di­ag­nos­tic test that us­es tar­get­ed high-through­put, par­al­lel se­quenc­ing tech­nol­o­gy to de­tect sin­gle-nu­cleotide vari­ants (SNVs), in­ser­tions, and dele­tions in 23 genes from DNA and fu­sions in ROS1 and RET from RNA iso­lat­ed from for­ma­lin-fixed, paraf­fin-em­bed­ded (FF­PE) tu­mor tis­sue sam­ples from pa­tients with non–small cell lung can­cer (NSCLC), IDH1 R132 mu­ta­tions from FF­PE tu­mor tis­sue sam­ples from pa­tients with cholan­gio­car­ci­no­ma (CC) and RET SNVs, MN­Vs, and dele­tions from DNA iso­lat­ed from FF­PE tu­mor tis­sue sam­ples from pa­tients with medullary thy­roid can­cer (MTC), and RET fu­sions from RNA iso­lat­ed from FF­PE tu­mor tis­sue sam­ples from pa­tients with thy­roid can­cer (TC) us­ing the Ion PGM Dx Sys­tem.

The On­comine Dx Ex­press Test is a qual­i­ta­tive in vit­ro di­ag­nos­tic test that us­es tar­get­ed next-gen­er­a­tion se­quenc­ing (NGS) tech­nol­o­gy and the Ion Tor­rent Genexus Dx Sys­tem to de­tect dele­tions, in­ser­tions, sub­sti­tu­tions, and copy num­ber gain present in 42 genes and fu­sions in 18 genes from DNA and RNA ex­tract­ed from for­ma­lin-fixed, paraf­fin-em­bed­ded (FF­PE) tu­mor tis­sue sam­ples. The On­comine Dx Ex­press Test al­so de­tects dele­tions, in­ser­tions and sub­sti­tu­tions in 42 genes and fu­sions in 7 genes from cfT­NA ex­tract­ed from plas­ma sam­ples. The On­comine Dx Ex­press Test is in­tend­ed to pro­vide clin­i­cal­ly rel­e­vant tu­mor mu­ta­tion pro­fil­ing in­for­ma­tion to be used by qual­i­fied health care pro­fes­sion­als in ac­cor­dance with pro­fes­sion­al guide­lines as an aid in ther­a­py man­age­ment of can­cer pa­tients with sol­id ma­lig­nant neo­plasms us­ing FF­PE sam­ples and as an aid in ther­a­py man­age­ment of can­cer pa­tients with non-small cell lung can­cer us­ing plas­ma sam­ples. It is not con­clu­sive or pre­scrip­tive for la­beled use of any spe­cif­ic ther­a­peu­tic prod­uct.