Sev­en plucky di­ag­nos­tics com­pa­nies win a $249M round of con­tracts af­ter sur­viv­ing NI­H's Covid-19 'Shark Tank' com­pe­ti­tion

As US Covid-19 deaths creep past 150,000 and of­fi­cials stress the im­por­tance of con­tact trac­ing, the NIH’s Rapid Ac­cel­er­a­tion of Di­ag­nos­tics (RADx) pro­gram has inked con­tracts to­tal­ing $248.7 mil­lion to ex­pand test­ing ca­pa­bil­i­ties.

The sev­en con­tracts, which were cho­sen “Shark Tank”-style from a pool of 100 pro­pos­als, are part of an ef­fort to bump dai­ly test­ing ca­pac­i­ty to 2% of the coun­try’s pop­u­la­tion by late sum­mer or fall. That would be about 6 mil­lion peo­ple per day, com­pared to the cur­rent 520,000 to 823,000 tests be­ing ad­min­is­tered dai­ly.

In to­tal, about 650 pro­pos­als were sub­mit­ted to the RADx project. Hun­dreds of in­dus­try “sharks” — in­clud­ing some from the Na­tion­al In­sti­tute of Bio­med­ical Imag­ing and Bio­engi­neer­ing’s (NIBIB) Point-of-Care Tech­nol­o­gy Re­search Net­work — eval­u­at­ed ap­pli­ca­tions. The NIH nar­rowed the pack down to 100, and in­tense eval­u­a­tion process be­gan.

On­ly 31 projects made it to Phase I RADx de­vel­op­ment, which in­volved four to six weeks of ini­tial tech­nol­o­gy val­i­da­tion. Sev­en have been pushed to Phase II so far, dur­ing which de­vel­op­ers will scale up fa­cil­i­ties, man­u­fac­ture tech­nolo­gies, and send prod­ucts to mar­ket. More than 20 of the com­pa­nies are still in Phase I, and could climb to Phase II in the com­ing weeks.

Dozens more pro­pos­als in the RADx “in­no­va­tion fun­nel” still have a shot at Phase I or II fund­ing. RADx mon­ey comes from a $1.5 bil­lion NIH ini­tia­tive an­nounced in April, which in­clud­ed $500 mil­lion ear­marked for di­ag­nos­tic de­vel­op­ment.

Alex Azar HHS

“RADx moved in­cred­i­bly quick­ly to se­lect promis­ing tech­nolo­gies through its ‘Shark Tank’ ap­proach, in­vest­ing in tech­nolo­gies that could boost Amer­i­ca’s best-in-the-world COVID-19 test­ing ca­pac­i­ty by mil­lions more tests per day,” HHS Sec­re­tary Alex Azar said in a pre­pared state­ment. “These tech­nolo­gies will help de­liv­er faster re­sults from labs and more and more test re­sults with­in min­utes at the point of care, which is es­pe­cial­ly im­por­tant for set­tings like schools and nurs­ing homes.”

The sev­en tech­nolo­gies cur­rent­ly in Phase II range from point-of-care to lab-based test­ing, and from nasal to sali­va sam­pling. The de­vel­op­ers span from Mass­a­chu­setts to Cal­i­for­nia. Each de­vel­op­er ei­ther has a pend­ing EUA ap­pli­ca­tion, or has re­ceived EUA from the FDA, which said it will pri­or­i­tize re­view of RADx projects.

Mesa Biotech

Mesa says its test will use re­verse tran­scrip­tion-poly­merase chain re­ac­tion (RT-PCR) tech­nol­o­gy to de­tect SARS-CoV-2 from nasal swabs with­in 30 min­utes — all from a palm-sized de­vice. The San Diego-based com­pa­ny de­vel­oped the test at the Los Alam­os Na­tion­al Lab­o­ra­to­ry, us­ing grants from the NIH, NI­AID, and West­ern Re­gion­al Cen­ters for Ex­cel­lence in Biode­fense and Emerg­ing In­fec­tious Dis­eases.

Now it’s full steam ahead. With $15.4 mil­lion from RADx, Mesa will push the clin­i­cal de­ploy­ment of its test on an ac­cel­er­at­ed time­line.

Quidel Cor­po­ra­tion

Quidel Cor­po­ra­tion’s take on point-of-care test­ing in­volves im­muno­flu­o­res­cence-based lat­er­al flow im­munoas­say tech­nol­o­gy, used to iden­ti­fy nu­cle­o­cap­sid pro­teins from SARS-CoV-2. The Sofia SARS Anti­gen FIA test kit re­ports re­sults from nasal swabs with­in 15 min­utes, and the com­pa­ny’s Read Now or Batch Test Mode can re­turn re­sults for up to 50 sam­ples in an hour. Quidel, head­quar­tered in San Diego, de­vel­oped the first anti­gen test to win FDA ap­proval in May.

The NIH’s $71 mil­lion con­tract will fund the ex­pan­sion of Quidel’s man­u­fac­tur­ing lines in San Diego, in­creas­ing its out­put from 84 mil­lion test cas­settes per year to more than 220 mil­lion. Quidel’s line of FDA-ap­proved as­says in the US in­cludes in­fluen­za A and B, res­pi­ra­to­ry syn­cy­tial virus (RSV), group A strep, and a 15-minute fin­ger-stick whole blood test for Ly­me dis­ease.

Tal­is Bio­med­ical Cor­po­ra­tion

Tal­is Bio­med­ical pro­duces the third point-of-care test in the RADx pipeline — a mul­ti­plexed car­tridge that de­tects SARS-CoV-2 us­ing isother­mal am­pli­fi­ca­tion of vi­ral RNA and an op­ti­cal de­tec­tion sys­tem. The Men­lo Park, CA-based com­pa­ny inked a $25 mil­lion con­tract for its Tal­is One Covid-19 test, which promis­es re­sults with­in 30 min­utes that are saved on the cloud. Though Tal­is cur­rent­ly has its sights set on Covid-19, it may pur­sue in­fluen­za, STIs, and oth­er in­fec­tions as fu­ture in­di­ca­tions.

Gink­go Bioworks

Gink­go Bioworks took home a $40 mil­lion con­tract to ex­pand its op­er­a­tional ca­pac­i­ty for large-scale Covid-19 test­ing at its au­to­mat­ed fa­cil­i­ties. The Boston-based biotech plans scale up to 50,000 tests per day in De­cem­ber, then 100,000 per day by year’s end. Re­sults are pro­vid­ed with­in 24 to 48 hours of sam­ple col­lec­tion.

Vol­ume is where Gink­go shines. Its next-gen­er­a­tion se­quenc­ing equip­ment (NGS) is de­signed to process many DNA and RNA sam­ples on the same ma­chine, al­low­ing thou­sands of tests to oc­cur at once. In May, Il­lu­mi­na pumped $70 mil­lion in­to the com­pa­ny to build in­fra­struc­ture for its au­to­mat­ed test­ing labs.

He­lix Op­Co

He­lix Op­Co will use $33.4 mil­lion in NIH fund­ing to up its test­ing ca­pac­i­ty to 100,000 per day by the fall. The plan is to ship nasal swab kits in bulk to pub­lic health de­part­ments, health care sys­tems, em­ploy­ers and more, and re­turn re­sults be­tween 24 and 48 hours lat­er.

For now, Cal­i­for­nia-based He­lix us­es re­al-time RT-PCR test­ing to qual­i­ta­tive­ly de­tect nu­cle­ic acid from SARS-CoV-2 in up­per res­pi­ra­to­ry pa­tients. But it has al­so filed an EUA re­quest for its Covid-19 NGS test, a more sen­si­tive test based on Oc­tant Bio’s “Swab­Seq” tech­nol­o­gy.

Flu­idigm Cor­po­ra­tion

Flu­idigm se­cured a con­tract of up to $37 mil­lion to up­scale pro­duc­tion of its Bio­mark HD mi­croflu­idics tech­nol­o­gy for Covid-19 test­ing, with $12 mil­lion in ini­tial fund­ing based on com­ple­tion of mile­stones. One of Flu­idigm’s plat­forms can test 6,000 sam­ples in 24 hours, “with low­er reagent re­quire­ments than com­pa­ra­ble sys­tems,” ac­cord­ing to the San Fran­cis­co-based com­pa­ny’s web­site.

Mam­moth Bio­sciences

An up­scale is in Mam­moth Bio­sciences’ fu­ture. The San Fran­cis­co-based biotech will ex­pand man­u­fac­tur­ing of its DE­TEC­TR test, which us­es CRISPR tech­nol­o­gy to iden­ti­fy nu­cle­ic acids in­dica­tive of SARS-CoV-2. The ex­pan­sion is in line with Mam­moth’s goal to in­crease and ac­cel­er­ate test­ing na­tion­wide us­ing its mech­a­nisms in com­mer­cial labs.

Mam­moth part­nered with Glax­o­SmithK­line in May to de­vel­op the CRISPR-based tests. The com­pa­ny en­vi­sioned a quick swab test for use in homes or even air­ports. The Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co re­cent­ly re­ceived EUA ap­proval to use the DE­TEC­TR reagent set.

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