Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an ex­ten­sive ef­fort to boost Covid-19 test­ing in the US, Gink­go Bioworks is ac­quir­ing and dis­trib­ut­ing 50 mil­lion rapid anti­gen tests that can po­ten­tial­ly be used for virus sur­veil­lance in schools and com­mu­ni­ties and for quick, on the ground di­ag­noses.

The tests, de­vel­oped by SD Biosen­sor, are in line with pro­pos­als from the Rock­e­feller Foun­da­tion and Har­vard epi­demi­ol­o­gists, among oth­ers, to blan­ket the coun­try with fast, low-cost tests. Al­though not yet au­tho­rized in the US, they are a key part of test­ing ef­forts from the Bill and Melin­da Gates Foun­da­tion, who an­nounced plans last month to dis­trib­ute 120 mil­lion of them in low and mid­dle in­come coun­tries. Roche has com­mer­cial­ized the di­ag­nos­tic in Eu­rope.

The tests can im­me­di­ate­ly be used for sur­veil­lance, where schools, of­fices or com­mu­ni­ties can mon­i­tor for out­breaks, as some places now do with waste­water test­ing and oth­er tech­nolo­gies. With an EUA, it could al­so be used to give in­di­vid­ual yes/no an­swers.

Gink­go’s new Covid-19 au­to­mat­ed, Il­lu­mi­na-equipped test­ing fa­cil­i­ty in Boston, set to open next month

Click on the im­age to see the full-sized ver­sion

Gink­go CEO Ja­son Kel­ly said he en­vi­sioned de­ploy­ing the tests in com­mu­ni­ties in the same way some north­east col­leges used once or twice-a-week test­ing to safe­ly re­open in the fall. He not­ed the US doesn’t even have the ca­pac­i­ty now to test a frac­tion of schools.

“If you look, in the US, it’s 20 mil­lion stu­dents and staff as­so­ci­at­ed with col­leges. So if you were test­ing them twice a week, it’d be about 5 mil­lion a day, and our na­tion­al ca­pac­i­ty for test­ing right now is a mil­lion tests a day,” Kel­ly told End­points News. “So if you’re go­ing to ac­tu­al­ly do some­thing like what was done for a small num­ber of col­leges na­tion­wide, you’ve got­ta bring on­line stuff like this.”

A decade-old up­start out of MIT, Gink­go grew to uni­corn sta­tus at the tail end of 2019 off the ro­bot­ic fac­to­ries it built to scale syn­thet­ic bi­ol­o­gy, sup­port­ing ap­pli­ca­tions on every­thing from fer­til­iz­er and per­fumes to nov­el an­tibi­otics and en­gi­neered mi­crobes.

Dur­ing the pan­dem­ic, though, the com­pa­ny has con­cen­trat­ed its ef­forts on di­ag­nos­tics. Most promi­nent­ly, in the spring, they un­veiled plans to use their ar­ray of Il­lu­mi­na se­quencers as a new kind of di­ag­nos­tic. With back­ing from the NIH’s RADx ini­tia­tive, Gink­go has built a new au­to­mat­ed fac­to­ry ded­i­cat­ed to that pur­pose in Boston. Once on­line next month, it should be able to process about 100,000 tests per day, or a full 10% in­crease in the na­tion’s cur­rent test­ing ca­pac­i­ty.

Ide­al­ly, Kel­ly said, they’d like to even­tu­al­ly use it for front-end pool test­ing, where a school or an of­fice mix­es sam­ples from, say, 10 dif­fer­ent peo­ple and tests them all to­geth­er in an ef­fort to get a broad sense of whether there’s an out­break.

“What you’re re­al­ly see­ing now is peo­ple put like 6 swabs in a tube and ship it to the lab,” Kel­ly said, laugh­ing. “But that’s a start. In a per­fect world they would al­so fig­ure out how to get the swabs out of there and just send a sam­ple to the lab that didn’t have swabs. But it’s start­ing to hap­pen.”

In the mean­time, they’re push­ing for­ward with the anti­gen plan. The tests they are now rolling out hold the same draw­backs that have swirled around anti­gen tests for months: the po­ten­tial for too many false pos­i­tives and too many false neg­a­tives. (Kel­ly, echo­ing ex­perts like Har­vard epi­demi­ol­o­gist Michael Mi­na, thinks the neg­a­tives aren’t much of a con­cern, as we’re al­ready miss­ing every­one we don’t test, though he thinks the pos­i­tives are worth watch­ing. “If you’re quar­an­ti­ning 5% of your work­force every day, it’s not go­ing to work,” he said.)

Gink­go al­so re­viewed the pa­per tests that E25Bio de­vel­ops and that Mi­na has been push­ing as a way to test near­ly every Amer­i­can every day. They de­cid­ed, though, that those weren’t yet read to scale — one of the key ad­van­tages of the SD Biosen­sor tech. Un­like some of the anti­gen tests from BD or Quidel, the SD Biosen­sor tests re­quire a much sim­pler de­vice to read. That could al­low for much broad­er man­u­fac­tur­ing and dis­tri­b­u­tion, sim­i­lar to the Ab­bott tests re­cent­ly pur­chased en masse by the gov­ern­ment.

The read­er “ba­si­cal­ly cre­ates a bot­tle­neck in how many tests you can ac­tu­al­ly do per day,” Kel­ly said. “If you can do it with­out a read­er then your bot­tle­neck is pret­ty much how many you can man­u­fac­ture.”

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Lat­est on ul­tra-rare dis­ease ap­proval; Pos­i­tive, if mixed, signs for Bio­gen's ALS drug; Clay Sie­gall finds a new job; and more

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Over the last four years, we’ve honored 80 women whose extraordinary accomplishments have changed the game in biopharma R&D. You can now nominate someone to be highlighted in this year’s special report. Details are here.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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Geoff McDonough, Generation Bio president and CEO

Mod­er­na part­ners on non-vi­ral gene ther­a­py with Gen­er­a­tion Bio af­ter swing­ing gene edit­ing deals

Moderna has inked a five-year partnership with gene therapy biotech Generation Bio, it announced Thursday morning, wading deeper into the genetic medicines space as it navigates beyond its vaccine work.

Moderna will pay Generation Bio $40 million upfront and invest another $36 million into the gene therapy biotech. In exchange, Moderna can license Generation Bio’s non-viral gene therapy platforms for two immune cell programs and two liver programs, with an option for a fifth program. Moderna will fund all the research work under the partnership, and could be on the hook for milestone, fee and royalty payments totaling up to $1.8 billion, a company spokesperson tells Endpoints News.

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Steven James, Pionyr Immunotherapeutics CEO

Gilead pass­es on ful­ly ac­quir­ing Pi­o­nyr, as eyes now turn to Tizona, a fel­low sum­mer 2020 buy­out op­tion

Gilead and Pionyr Immunotherapeutics, a biotech trying to follow up on the first generation of checkpoint inhibitors, have “mutually agreed” on a rewrite to their 2020 terms, with Gilead deciding not to buy out the company.

The California biopharma waived its option to acquire the remaining 50.1% of Pionyr, which would have triggered a $315 million upfront payment and up to $1.15 billion down the road. Had Gilead waited to decide, the drugmaker would have had a potential payment to make in the near term under their agreement, a spokesperson said in an email to Endpoints News.

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