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.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval this week while also giving thumbs up for six expanded indications, including Novo Nordisk’s approved obesity medication Wegovy for younger people. Wegovy is already approved as an obesity treatment in the EU for adults, and the new indication would allow prescriptions for adolescents aged 12 and older.

RNA biotech GreenLight Biosciences has been handed an offer for potential acquisition.

GreenLight said in a release that it has received a non-binding “indication of interest” from Fall Line Endurance Fund to acquire GreenLight’s capital stock for $0.60 per share in cash. The release said any potential agreement between the two parties would depend on certain conditions.

Through a special committee, the biotech will evaluate the offer but added there’s no certainty a deal will go forward. GreenLight will also not make any more announcements until a deal comes through or “otherwise determines” a statement is necessary.

A public T cell biotech’s chief executive has decided to leave the company.

TScan Therapeutics said Friday morning that CEO David Southwell stepped down earlier this week, leaving both his chief executive and board member roles. Filling in is Gavin MacBeath, the company’s CSO and COO. He became the acting CEO on Tuesday, and will continue to remain CSO and COO, TScan’s announcement read.