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.

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

Secretary of health and human services Alex Azar speaking in the Rose Garden at the White House (Photo: AFP)

Trump’s HHS claims ab­solute au­thor­i­ty over the FDA, clear­ing path to a vac­cine EUA

The top career staff at the FDA has vowed not to let politics overrule science when looking at vaccine data this fall. But Alex Azar, who happens to be their boss’s boss, apparently won’t even give them a chance to stand in the way.

In a new memorandum issued Tuesday last week, the HHS chief stripped the FDA and other health agencies under his purview of their rule making ability, asserting all such power “is reserved to the Secretary.” Sheila Kaplan of the New York Times first obtained and reported the details of the September 15 bulletin.

President Donald Trump (via AP Images)

Signs of an 'Oc­to­ber Vac­cine Sur­prise' alarm ca­reer sci­en­tists. HHS con­tin­ues to claim Azar “will de­fer com­plete­ly to the FDA"

President Donald Trump, who seems intent on announcing a Covid-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the FDA and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process.

Embattled CDC director Robert Redfield (AP Images)

Covid-19 roundup: CDC ad­vi­so­ry com­mit­tee de­lays pri­or­i­ty dis­tri­b­u­tion vote; EU re­port­ed­ly in­dem­ni­fy­ing vac­cine mak­ers

A federal committee that advises the CDC was expected to hold a vote Tuesday on a plan regarding the distribution for initial doses of approved Covid-19 vaccines. But that vote has been scrapped.

The Advisory Committee on Immunization Practices, or ACIP, won’t be voting until the committee members learn more about which vaccines become available first, the Wall Street Journal reported. The vote could potentially wait until a specific vaccine is authorized before recommending how to dole out the first doses.

Samit Hirawat (Bristol Myers Squibb)

Af­ter bruis­ing re­jec­tion, blue­bird and Bris­tol My­ers Squibb land ide-cel pri­or­i­ty re­view. But will it mat­ter for the CVR?

With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger.

The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that threatened to foreclose the CVR entirely. Today’s acceptance sets the FDA decision date for March 27, 2021 – or precisely 4 days before the CVR deadline of March 31. Given the breakthrough designation and strong pivotal data — 81.5% response rate, 35.2% complete response rate — priority review was largely expected.

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#ES­MO20: Push­ing in­to front­line, Mer­ck and Bris­tol My­ers duke it out with new slate of GI can­cer da­ta

Having worked in parallel for years to move their respective PD-1 inhibitors up to the first-line treatment of gastrointestinal cancers, Merck and Bristol Myers Squibb finally have the data at ESMO for a showdown.

Comparing KEYNOTE-590 and CheckMate-649, of course, comes with the usual caveats. But a side-by-side look at the overall survival numbers also offer some perspective on a new frontier for the reigning checkpoint rivals, both of whom are claiming to have achieved a first.

Can a mag­net­ic cell ther­a­py re­place corneal trans­plan­ta­tion? As eight-year jour­ney leads to the clin­ic, two broth­ers un­veil bold vi­sion

Jeff Goldberg was getting acquainted with a brand new way to do corneal transplants when an even newer, even bolder idea hit him.

It was almost 10 years ago, and Goldberg was in his first faculty position at Bascom Palmer Eye Institute at the University of Miami. Scientists had developed a new way to do cornea transplants where instead of sewing a whole donor cornea — a decades-old practice — they were just engrafting the inner layer of cells.

News brief­ing: Tiny Vac­cinex's drug flops in PhII Hunt­ing­ton's tri­al, stock craters; Siol­ta nabs $30M Se­ries B to de­vel­op mi­cro­bio­me drug

Siolta Therapeutics, a microbiome company targeting allergic diseases, raked in a $30 million Series B to develop its lead candidate, STMC-103H. The drug, which has been FDA fast-tracked, is headed for proof-of-concept trials, according to the company. Its various indications include allergic asthma, food allergies, atopic dermatitis, allergic rhinitis, and allergy prevention.

The news comes just after the California-based biotech added a prominent biopharma veteran as an advisor: 20-year Gilead CEO John Martin. The biotech also gained Richard Shames as CMO, who came by way of Protagonist Therapeutics.

Anthony Coyle (Repertoire)

Flag­ship's merged biotech Reper­toire nets ex-Pfiz­er CSO An­tho­ny Coyle as R&D chief

Flagship is building a big-name C-suite at its new, $220 million merged biotech.

Repertoire Immune Medicines, which already boasts former Bioverativ chief John Cox as its CEO, announced yesterday that Anthony Coyle, the former Pfizer CSO and the founding CEO of Pandion, will join as their head of R&D.

“As we progress clinical trials for our multi-clonal T cell candidates in immuno-oncology, Tony’s deep expertise in cellular immunology and novel therapeutic development will help us achieve our vision of creating a new class of transformative medicines for patients,” Cox said in a statement.

Zai Lab hauls in $761M from Hong Kong IPO to push Ze­ju­la, more bud­ding can­di­dates in Chi­na — re­port

Zai Lab is set to net more than $761 million from its secondary listing in Hong Kong after pricing the IPO at $72.51 (HKD$562) — just a hair below its Nasdaq closing price on Monday, Bloomberg and Nikkei Asian Review reported.

A pioneer in bringing Western drugs to China, co-founder and CEO Samantha Du has more than tripled Zai Lab’s market cap in the three years it’s been public in the US. The HKEX listing is designed to fund R&D and commercialization for the current portfolio while fueling new in-licensing pacts, the biotech wrote in a filing.