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.”

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Spe­cial re­port 2022: Meet 20 women blaz­ing trails in bio­phar­ma R&D

When you run a special report for a fourth year, it can start feeling a little bit like a ritual. You go through the motions — in our case opening up nominations for top women in biopharma R&D and reviewing more than 500 entries — you make your choices of inclusion and exclusion. You host a ceremony.

But then things happen that remind you why you do it in the first place. Perhaps a Supreme Court rules to overturn the constitutional right to abortion and a group of women biotech leaders makes it clear they strongly dissent; perhaps new data on gender diversity in the industry come out that look all too similar to the old ones, suggesting women are still dramatically underrepresented at the top; perhaps protests and conflicts around the world put in stark terms the struggles that many women still face in earning the most basic recognition.

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Kristen Hege, Bristol Myers Squibb SVP, early clinical development, oncology/hematology and cell therapy (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: Bris­tol My­er­s' Kris­ten Hege on cell ther­a­py, can­cer pa­tients and men­tor­ing the next gen­er­a­tion

Kristen Hege leads Bristol Myers Squibb’s early oncology discovery program carrying on from the same work at Celgene, which was acquired by BMS in 2019. She’s known for her early work in CAR-T, having pioneered the first CAR-T cell trial for solid tumors more than 25 years ago.

However, the eminent physician-scientist is more than just a drug developer mastermind. She’s also a practicing physician, mother to two young women, an avid backpacker and intersecting all those interests — a champion of young women and people of color in STEM and life sciences.

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Gossamer Bio CEO Faheem Hasnain at Endpoints' #BIO22 panel (J.T. MacMillan Photography for Endpoints News)

Gos­samer’s Fa­heem Has­nain de­fends a round of pos­i­tive PAH da­ta as a clear win. But can these PhII re­sults stand up to scruti­ny?

Gossamer Bio $GOSS posted a statistically significant improvement for its primary endpoint in the key Phase II TORREY trial for lead drug seralutinib on Tuesday morning. But CEO Faheem Hasnain has some explaining to do on the important secondary of the crucial six-minute walk distance test — which will be the primary endpoint in Phase III — as the data on both endpoints fell short of expectations, missing one analyst’s bar on even modest success.

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Vikram Sheel Kumar, Clear Creek Bio CEO

In search for next-gen Covid treat­ment, Pfiz­er taps tiny biotech for re­search deal

Pfizer has inked a deal to develop a new Covid therapy with Clear Creek Bio — a 10-person biotech out of RA Capital with an office in Cambridge, MA, but one that operates fully remotely.

Paxlovid has become a big moneymaker for Pfizer this year, projecting $22 billion in sales on the year. But the Big Pharma has begun its search for a next-generation Covid antiviral and potential combination therapies as supply of Paxlovid greatly eclipses actual use of the antiviral.

Graphic: Shutterstock

Prometheus moves to raise cash hours af­ter PhII da­ta leads to stock surge

After releasing better-than-anticipated data on two mid-stage studies Wednesday morning, Prometheus Biosciences’ CEO said the company would “take some time to assess” its next financing options.

It only needed about seven hours. Wednesday afternoon after the market closed, the biotech announced it would seek $250 million through an equity offering as the company looks to edge out anti-TL1A competitor Pfizer and its new partner Roivant.

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Piper Trelstad, head of CMC, Bill & Melinda Gates Medical Research Institute

Q&A with Gates leader: Women tak­ing on more roles in phar­ma man­u­fac­tur­ing, but still work to do

More and more women are driving innovation and taking leadership roles in biotech – as evidenced today in the release of Endpoints News’ list of the top 20 women in the R&D world – but those gains are beginning to extend across pharma sectors.

In pharma manufacturing in the US today, around 46% of all roles are occupied by women, according to the US Bureau of Labor Statistics for 2021. And according to a Bloomberg report, women’s roles across manufacturing roles had a massive boost after the start of the pandemic.

Phar­ma rep­u­ta­tion re­tains 'halo' even as pan­dem­ic me­dia cov­er­age re­cedes — sur­vey

The Covid-19 halo effect on the pharma industry is continuing, according to a new global study from Ipsos. The annual survey for the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) finds considerable goodwill from consumers across measures of trust, cooperation with governments, and advancing research and drug development.

“Despite the pandemic in many countries no longer being the top of mind concern generally – although it does remain the top concern as a health issue – the industry’s reputation has remained positive,” said Ipsos research director Thomas Fife-Schaw.

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FDA commissioner Robert Califf (Jose Luis Magana/AP Images)

FDA pulls On­copep­tides' Pepax­to in­di­ca­tion, open­ing the door for dan­gling ac­cel­er­at­ed ap­proval en­force­ment

In a move all but ensured after an overwhelmingly negative adcomm vote this September, the FDA is yanking Oncopeptides’ dangling accelerated approval. And there may be more to come.

In recent months, US regulators have honed in on reforming the accelerated approval pathway and preventing drugmakers from continuing to sell their medicines in the event of a confirmatory study flop. The moves come after commissioner Rob Califf has called for companies to do more to produce post-marketing evidence quickly earlier this year.

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