Clin­i­cal tri­al mon­i­tor­ing is about to change for­ev­er

In 2006, a clin­i­cal tri­al called IL­LU­MI­NATE halt­ed abrupt­ly. Tri­al sub­jects treat­ed with an in­ves­ti­ga­tion­al drug called torce­trapib start­ed ex­pe­ri­enc­ing un­ex­pect­ed car­dio­vas­cu­lar prob­lems, in some cas­es re­sult­ing in death. Af­ter 15 years and near­ly 1 bil­lion dol­lars, the de­vel­op­ment of torce­trapib froze.

Nine years lat­er, a pa­per pub­lished in the jour­nal Cir­cu­la­tion ex­plained how the IL­LU­MI­NATE dis­as­ter could have been pre­dict­ed and pre­vent­ed if just 9 pro­teins had been mea­sured in clin­i­cal tri­al par­tic­i­pants fol­low­ing ini­tial treat­ments.

The chal­lenge and promise of pro­teomics

There is one uni­ver­sal truth when it comes to dis­ease pathol­o­gy, no mat­ter what kind of dis­ease we’re talk­ing about: pro­teins change. Whether by shift­ing pat­terns of ex­pres­sion, post-trans­la­tion­al mod­i­fi­ca­tions, in­tra and ex­tra-cel­lu­lar trans­port, or – usu­al­ly – all of the above, when health sta­tus changes, pro­teins change. The ques­tion is, which pro­teins?

Endpoint News

All of the news, delivered with full-text to your inbox. For professionals discovering, developing, and marketing biopharmaceutical drugs.

For the past 20 years, So­ma­Log­icTM has strived to si­mul­ta­ne­ous­ly an­swer this ques­tion and make it ir­rel­e­vant. If you don’t know which pro­teins to look at, the ob­vi­ous ap­proach is to as­say all of them, or as many as tech­no­log­i­cal­ly pos­si­ble. For that, we built the So­maS­can® As­say, a pro­teomics plat­form that lever­ages mod­i­fied ap­tamers for near lim­it­less mul­ti­plex­ing ca­pa­bil­i­ties.

The first it­er­a­tion of the So­maS­can As­say mea­sured 400 pro­teins. We quick­ly grew that num­ber to 800, 1,030, 1,129, 1,305, and now 5,000. At 5,000 pro­teins, the So­maS­can As­say can de­liv­er 250% more pro­tein mea­sure­ments than any oth­er high-through­put pro­teomics plat­form on the mar­ket, and it’s poised to ex­pand.

What we built in the So­maS­can As­say, is an in­cred­i­bly pow­er­ful tool for pro­tein bio­mark­er dis­cov­ery. Along with our many aca­d­e­m­ic and in­dus­try col­lab­o­ra­tors, we’ve ex­ten­sive­ly an­a­lyzed So­maS­can da­ta in a va­ri­ety of pa­tient groups in or­der to iden­ti­fy which pro­tein sig­na­tures are most rel­e­vant for a giv­en clin­i­cal met­ric. The re­sult is our new­ly launched So­maSig­nal™ Tests.

From pro­teom­ic da­ta to clin­i­cal met­ric

So­maSig­nal Tests are de­vel­oped by an­a­lyz­ing thou­sands of pro­teins in thou­sands of pa­tients us­ing the So­maS­can As­say. Pro­tein sig­na­tures re­vealed by the So­maS­can As­say are com­pared against stan­dard clin­i­cal met­rics in or­der to iden­ti­fy pat­terns of pro­tein changes that cor­re­late with cur­rent health sta­tus and fu­ture tra­jec­to­ry us­ing ma­chine learn­ing.

Each pat­tern be­comes the ba­sis for a spe­cif­ic So­maSig­nal Test, of which there are cur­rent­ly 18. Two of those tests, which pre­dict pri­ma­ry and sec­ondary car­dio­vas­cu­lar risk, were de­vel­oped from fur­ther in­ves­ti­ga­tion of the 9 pro­teins that were crit­i­cal in the IL­LU­MI­NATE tri­al.

Be­cause each So­maSig­nal test is gen­er­at­ed us­ing da­ta from sub­sets of the same 5,000 pro­teins, re­sults for all the So­maSig­nal tests can be de­rived from a sin­gle 55µl blood sam­ple. Eigh­teen tests is the first step to­wards a com­pre­hen­sive liq­uid health check: with many more in our de­vel­op­ment pipeline.

Mov­ing to­wards a com­pre­hen­sive liq­uid health check

The de­vel­op­ment of the So­maSig­nal Tests is sys­tem­at­ic and found­ed on a body of peer-re­viewed re­search. As a re­sult, the menu of tests to­day is large­ly fo­cused on a few dis­ease/health ar­eas. We have tests for heart dis­ease/fail­ure risk, liv­er health, in­clud­ing non-in­va­sive in­di­ca­tors for non-al­co­holic steato­hep­ati­tis, and tests re­lat­ing to meta­bol­ic health and di­a­betes, such as blood glu­cose tol­er­ance and body fat.

We make a few well-de­fined and well-sup­port­ed claims when it comes to the So­maSig­nal Tests. You can use them to strat­i­fy pa­tients, pre­dict risk, mon­i­tor treat­ment ef­fi­ca­cy, and gain in­sights in­to mech­a­nisms of ac­tion, us­ing 18 dif­fer­ent clin­i­cal met­rics, all from a sin­gle blood sam­ple.

To­day, the So­maSig­nal Tests can help im­prove and in­crease the speed of clin­i­cal tri­als and make them safer for par­tic­i­pants. To­mor­row, we’ll con­tin­ue ex­pand­ing to­wards that vi­sion by build­ing a suite of clin­i­cal re­search tests based on a foun­da­tion of da­ta and 5,000 pro­teins (and count­ing).

We are work­ing now to de­vel­op tests for ad­di­tion­al ap­pli­ca­tions, such as neu­ro­log­i­cal health, au­toim­mune dis­eases, can­cer, in­fec­tious dis­eases, as well as healthy sleep, fit­ness, nu­tri­tion, and ag­ing. But we need your help. Col­lab­o­rate with us and help us iden­ti­fy pro­tein sig­na­tures for new dis­ease ar­eas. Use our tests in your clin­i­cal tri­als to find the right pa­tients faster and char­ac­ter­ize and mon­i­tor them in ways that were pre­vi­ous­ly un­avail­able.