- Spitfire List - https://spitfirelist.com -

Peter Thiel’s “Curative” Influence

Mr. Emory’s entire life’s work is avail­able on a 32GB flash dri­ve, avail­able for a con­tri­bu­tion of $65.00 or more (to KFJC). Click Here to obtain Dav­e’s 40+ years’ work, com­plete through Fall of 2020 [through FTR #1156]. [1]

WFMU-FM is pod­cast­ing For The Record–You can sub­scribe to the pod­cast HERE [2].

You can sub­scribe to e‑mail alerts from Spitfirelist.com HERE [3].

You can sub­scribe to RSS feed from Spitfirelist.com HERE [3].

Please con­sid­er sup­port­ing THE WORK DAVE EMORY DOES [4]

Note: This web­site is licensed for Fair Use under Cre­ative Com­mons. No mon­ey what­so­ev­er is, has been, or will be made from this web­site by Mr. Emory.

COMMENT: The sever­i­ty of the pan­dem­ic, the pro­found dis­lo­ca­tion to soci­ety as a whole and to indi­vid­u­als and fam­i­lies, the errat­ic, irre­spon­si­ble char­ac­ter of the Trump admin­is­tra­tion and the tremen­dous temp­ta­tion to rich­es afford­ed by the cir­cum­stances have birthed a com­mer­cial cli­mate ripe for suc­cess­ful exploita­tion by cor­po­rate inter­ests will­ing to game the land­scape.

” . . . . It’s a sto­ry root­ed in a debil­i­tat­ed pub­lic sec­tor that in response to an over­whelm­ing cat­a­stro­phe opt­ed to relax reg­u­la­tions and place its faith in com­pa­nies large and small that were ready and able to prof­it from a once-in-a-cen­tu­ry pan­dem­ic. . . .”

Said sto­ry is that of a firm called Cura­tive, head­ed by Fred Turn­er, a Peter Thiel pro­tege who suc­cess­ful­ly mar­ket­ed a sim­pli­fied test­ing procedure–partially fund­ed by the Pentagon–that ini­tial­ly reaped rich finan­cial rewards.

With the pas­sage of time, severe doubts emerged as to the effi­ca­cy of Turner/Curative’s sim­pli­fied test­ing:

” . . . . Seek­ing to expand its FDA autho­riza­tion, Cura­tive by Octo­ber had con­clud­ed a large clin­i­cal study par­tial­ly fund­ed by the Defense Depart­ment of 1,300 self-report­ed asymp­to­matic peo­ple who drove through sites in Los Ange­les and San Anto­nio.

The FDA was not pleased with the results, sub­mit­ted in Decem­ber, after con­duct­ing its own analy­sis of the study, accord­ing to emails obtained by BullDog.com [5], a Flori­da news out­let. Cura­tive and the FDA declined to release the emails to The Times.

An FDA review­er told the com­pa­ny a few days before Christ­mas that it found the test did not even appear to be accu­rate on symp­to­matic peo­ple, much less those with­out any symp­toms, accord­ing to Bull­Dog. Although Cura­tive pro­vid­ed addi­tion­al data to the FDA that Turn­er said dis­put­ed the analy­sis, the agency was unmoved and issued its safe­ty com­mu­ni­ca­tion. . . . .”

 

“COVID-19 turned a tiny start-up into a test­ing giant. But can its results be trust­ed? ” by Lau­rence Darmien­to, Melody Petersen; The Los Ange­les Times; 03/24/2021 [6]

It was a one-two punch that could dam­age an estab­lished com­pa­ny, much less a year-old start-up.

In Jan­u­ary, the Food and Drug Admin­is­tra­tion cau­tioned that COVID-19 tests made by Cura­tive might inform patients they were free of the virus when they weren’t.

A so-called false neg­a­tive that would allow infect­ed peo­ple to unwit­ting­ly spread the dead­ly ill­ness.

Not long after, admin­is­tra­tors at a Col­orado health sys­tem grew skep­ti­cal over a string of pos­i­tive results from Cura­tive and decid­ed to have employ­ees retest­ed by anoth­er lab — only to find the orig­i­nal results were wrong.

A so-called false pos­i­tive, in a health­care set­ting where infect­ed patients are kept togeth­er, could expose those who actu­al­ly don’t have the virus to those who do.

“It’s scary,” said Yvonne Myers, the system’s direc­tor. “You could give them COVID.”

At a time when the stan­dard COVID-19 test relied on a cot­ton-swab probe deep inside the nos­trils, Cura­tive promised accu­rate results if peo­ple would just cough and swab their mouths — an approach that dif­fered from estab­lished sci­ence.

Led by Fred Turn­er — a 25-year-old who dropped out of Oxford to pur­sue his entre­pre­neur­ial dreams — Cura­tive had in a year gone from few­er than a dozen employ­ees to ser­vic­ing mass test­ing sites such as Dodger Sta­di­um, con­duct­ing more than 17 mil­lion COVID-19 tests. It may have grossed $1 bil­lion or more in tax­pay­er mon­ey and insur­ance pre­mi­ums.

The pri­vate­ly held Los Ange­les-area start-up had become California’s lat­est ven­ture-cap­i­tal-backed suc­cess sto­ry, a vic­tor of the coro­n­avirus econ­o­my that at one point said it was per­form­ing about 10% of all tests admin­is­tered each week in the U.S. But ques­tions have mount­ed about its test’s accu­ra­cy.

Turn­er stands by his company’s test and attrib­ut­es Curative’s rapid growth to its abil­i­ty to devel­op a sim­ple diag­nos­tic, build a robust sup­ply chain and process mil­lions of tests as oth­er labs were over­whelmed.

“We came in and filled this void where oth­ers couldn’t scale up,” said Turn­er, the company’s co-founder and chief exec­u­tive.

In a bid to improve his company’s rep­u­ta­tion, Turn­er has sub­mit­ted to the FDA results of two clin­i­cal stud­ies designed and car­ried out on his own employ­ees in a mat­ter of weeks. He boasts they show his test is bet­ter than the stan­dard, uncom­fort­able swab of the nasophar­ynx test backed by the fed­er­al agency — though they have yet to be peer-reviewed or pub­lished inde­pen­dent­ly.

One year into the pan­dem­ic, much of the world has moved on from test­ing and turned its focus to vac­cine sup­ply, includ­ing Cura­tive, which is dis­trib­ut­ing vac­cines as it looks to rein­vent itself. But the sto­ry of how a tiny start-up with an uncon­ven­tion­al diag­nos­tic mush­roomed into a bil­lion-dol­lar test­ing jug­ger­naut illu­mi­nates just how unpre­pared L.A. Coun­ty, Cal­i­for­nia and the nation were for what was com­ing. It’s a sto­ry root­ed in a debil­i­tat­ed pub­lic sec­tor that in response to an over­whelm­ing cat­a­stro­phe opt­ed to relax reg­u­la­tions and place its faith in com­pa­nies large and small that were ready and able to prof­it from a once-in-a-cen­tu­ry pan­dem­ic.

“We didn’t have the pub­lic health facil­i­ties set up to real­ly take part in help­ing keep the pop­u­la­tions in this coun­try safe,” said Michael Mina, an epi­demi­ol­o­gist at the Har­vard T. H. Chan School of Pub­lic Health. “And so this led to a huge deci­sion to lean heav­i­ly on pri­vate indus­try.”

Unex­pect­ed oppor­tu­ni­ty

When COVID-19 arrived, decades of under-invest­ment had prompt­ed the clo­sure of 1 in 4 of California’s pub­lic health labs [7], leav­ing the state with few­er than one lab per mil­lion res­i­dents and many with annu­al equip­ment bud­gets of zero dol­lars. Oth­er states found them­selves sim­i­lar­ly unable to scale up the mas­sive test­ing need­ed to keep the pan­dem­ic in check.

Com­mer­cial and oth­er labs sprung into action, and the FDA cleared the way for more than 200 COVID-19 tests under its “emer­gency use autho­riza­tion” process. That expe­dit­ed review allows test devel­op­ers to begin sell­ing their test as long as they reg­is­ter with the FDA and fol­low up with lim­it­ed research show­ing they “may be effec­tive.”

Many labs began mak­ing tests to col­lect sam­ples from the upper throat where the pathogens are known to col­o­nize — so-called nasopha­ryn­geal tests, the long­time stan­dard for diag­nos­ing influen­za and oth­er res­pi­ra­to­ry virus­es. Reach­ing the area with a long swab is not only high­ly unpleas­ant, but it also needs to be done by trained med­ical per­son­nel in pro­tec­tive gear.

Turn­er thought he had a bet­ter idea.

He had been in the San Fran­cis­co Bay Area for sev­er­al years try­ing to get a start-up off the ground. As a teenag­er, he had assem­bled a poly­merase chain reac­tion machine to fig­ure out why he didn’t have red hair like his moth­er and broth­er. That same tech­nol­o­gy is used to detect COVID-19 cas­es.

The achieve­ment gar­nered him awards [8], lead­ing to an unso­licit­ed offer from a farmer to buy the device to genet­i­cal­ly test his cows. Turn­er fig­ured the farmer was on to some­thing and cre­at­ed a com­pa­ny aimed at offer­ing cheap, $15 genet­ic tests to improve herds.

That com­pa­ny, TL Bio­labs, earned him a slot in the famed Moun­tain View, Calif., accel­er­a­tor Y Com­bi­na­tor [9] and a Thiel Fel­low­ship, which award­ed him $100,000 for drop­ping out of Oxford Uni­ver­si­ty to pur­sue the start-up full time.

The idea didn’t pan out. “You have to basi­cal­ly cap­ture every sin­gle cow in the entire U.S. for it to be a bil­lion-dol­lar busi­ness,” Turn­er came to real­ize.

TL Bio­labs decid­ed to apply its tech­nol­o­gy to human infec­tions, and Turn­er con­tin­ued fundrais­ing, amass­ing a total of more than $10 mil­lion before the com­pa­ny failed. He had start­ed Cura­tive to con­tin­ue that work — just as COVID-19 emerged.

Based on data from the 2003 SARS out­break, Turn­er con­clud­ed there prob­a­bly would be a suf­fi­cient viral load in oral flu­ids to detect the coro­n­avirus. By adapt­ing the coro­n­avirus test devel­oped by the Cen­ters for Dis­ease Con­trol and Pre­ven­tion, Cura­tive in Feb­ru­ary 2020 cre­at­ed its own pro­to­type.

Because Curative’s test is self-admin­is­tered — peo­ple are told to cough three times and then swab their gums, tongue and oth­er areas inside their mouths for at least 20 sec­onds — there is no need for med­ical observers to con­stant­ly change out of per­son­al pro­tec­tive equip­ment, which was in short sup­ply. And although the FDA required trained observers to mon­i­tor patients as they per­form the test, the agency did not spec­i­fy they need­ed med­ical cer­ti­fi­ca­tion. So Cura­tive was able to tap cheap­er tem­po­rary work­ers, includ­ing some with just a high school edu­ca­tion, or rely on part­ners, such as Sean Penn’s non­prof­it CORE at Dodger Sta­di­um.

Antic­i­pat­ing huge demand for high-speed test­ing, the com­pa­ny built up data­base soft­ware, devel­oped a field oper­a­tion and ensured its lab could han­dle the vol­ume.

lnvestors were excit­ed by the test’s poten­tial. Cura­tive raised an addi­tion­al $1 mil­lion from angel investors and Palo Alto ven­ture cap­i­tal firm DCVC. A few months lat­er, DCVC, Burlingame ven­ture cap­i­tal firm Refac­tor Cap­i­tal and Chris Ander­son, the cura­tor of the TED speak­er series [10], led an $8.8‑million fund­ing round to scale up the test­ing, a com­pa­ny spokesper­son said.Advertisement

Ander­son said Turn­er, with his easy-to-admin­is­ter test and oth­er inno­va­tions, had hit upon the same for­mu­la for suc­cess that he wrote about in a 2013 For­tune cov­er sto­ry [11] on Steve Jobs and Elon Musk — “sys­tem-lev­el design think­ing” as much as great prod­ucts.

“That’s what the test­ing regime need­ed back in Feb­ru­ary. It wasn’t great sci­ence — the sci­ence of what a PCR test looks like was actu­al­ly known,” Ander­son said. “The prob­lem was a mat­ter of logis­tics. How do you scale up some­thing like that? It’s about fig­ur­ing out how you man­age com­plex bar­code sys­tems on a spread­sheet. And doing that real­ly fast.”

Though its Bay Area loca­tion put Cura­tive at the heart of the world’s ven­ture cap­i­tal ecosys­tem, the com­pa­ny was hav­ing trou­ble find­ing a local lab that met FDA stan­dards to han­dle human tests, in high demand amid the pan­dem­ic. Turn­er found one in San Dimas through Mars­Bio, an L.A. biotech ven­ture cap­i­tal firm where one of his Y Com­bi­na­tor class­mates had land­ed. Turn­er and his small team relo­cat­ed to L.A. Coun­ty in March, work­ing from hotels and Airbnbs as they got the test off the ground.

The move put Cura­tive in prox­im­i­ty to the city gov­ern­ment of Los Ange­les, which had sus­pend­ed the nor­mal bid­ding process in hopes of quick­ly find­ing a com­pa­ny that could ramp up mass test­ing. The city chose Cura­tive, a spokesper­son said, because it showed an abil­i­ty to scale up rapid­ly, offered a self-admin­is­tered test, and used a local lab so it could get results back faster.

The com­pa­ny used its deal with Los Ange­les to open doors across the coun­try. In an online sales brochure [12], it includ­ed a link to a video of scores of cars lin­ing up for Cura­tive tests at Dodger Sta­di­um tweet­ed by May­or Eric Garcetti. [13].

Turn­er also ben­e­fit­ed from his ven­ture cap­i­tal net­work. Cura­tive joined up with Gothams, a con­sult­ing firm found­ed by a DCVC part­ner that includes for­mer spe­cial oper­a­tions mil­i­tary offi­cers and aero­space exec­u­tives. The com­pa­ny soon inked deals to test mem­bers of Con­gress, employ­ees of the Depart­ment of Defense and res­i­dents of Texas, Alas­ka, Flori­da and Delaware.

Sub­si­dized test

Turn­er had failed to break into the diag­nos­tics indus­try with TL Bio­labs after dis­cov­er­ing the mar­ket wasn’t suit­able for mass cheap test­ing.

But this time the cir­cum­stances were dif­fer­ent. The cheap part wasn’t a neces­si­ty.

The fed­er­al gov­ern­ment ear­ly in the pan­dem­ic poured bil­lions into test­ing. In March, Con­gress passed the fed­er­al CARES Act, requir­ing health insur­ers to cov­er the cost of tests, with no out-of-pock­et cost to the patients, which has allowed com­pa­nies such as Cura­tive to offer the ser­vice free.

“You will nev­er receive a bill from Cura­tive for a covid-19 test,” Turn­er tweet­ed on Jan. 11.

In Los Ange­les, the city paid Cura­tive $115 to $150 upfront for each test kit as they were deliv­ered by the thou­sands each day to Dodger Sta­di­um and oth­er sites across the city, accord­ing to invoic­es reviewed by The Times.

By late June, Los Ange­les had paid $62 mil­lion to Cura­tive when the city asked the com­pa­ny to begin billing health insur­ers, a city spokes­woman said. The com­pa­ny billed the city an addi­tion­al $19.8 mil­lion through the end of last year, includ­ing for test­ing the unin­sured. The city is seek­ing fed­er­al reim­burse­ment for all those test­ing costs, she said.

Cur­rent­ly, Cura­tive bills health insur­ers $325 — $250 for the test and $75 to col­lect the spec­i­men, accord­ing to the company’s web­site. The com­pa­ny said health insur­ers and states pay less than the pub­lished price, typ­i­cal­ly about $100 or the Medicare rate for a fast turn­around test.

That kind of pric­ing across the indus­try has drawn crit­i­cism from pub­lic health advo­cates. Mina fig­ures that the actu­al costs of an aver­age test run by high through­put labs — which per­form hun­dreds of thou­sands of most­ly auto­mat­ed tests per week — is per­haps $8 plus a “few extra” dol­lars for over­head.

Turn­er said that labs that may only process tests are an inap­pro­pri­ate com­par­i­son to Cura­tive because his com­pa­ny pro­vides its own test kits, has a large field oper­a­tion and some­times char­ters flights to rapid­ly get sam­ples back to its labs.

“Over­all, we’ve already spent more mon­ey on the stuff that isn’t the lab test than on the lab test,” he said.

The com­pa­ny declined to dis­cuss its rev­enues or prof­its. Turn­er also declined to break down the costs of the company’s test from the over­head. How­ev­er, using his $100 reim­burse­ment fig­ure, Cura­tive could have brought in more than $1 bil­lion in rev­enues from its test­ing pro­gram.

FDA con­cerns

The FDA grant­ed Cura­tive an emer­gency use autho­riza­tion for its oral flu­ids test in April but had con­cerns about the company’s test from the start.

Based on the company’s study data, the FDA required that its admin­is­tra­tion be close­ly observed by trained health­care work­ers. It also barred Cura­tive from pro­mot­ing its use for asymp­to­matic peo­ple.

In a med­ical jour­nal, Turn­er and his col­leagues wrote that the poor per­for­mance when its test wasn’t close­ly over­seen by a health­care work­er was unex­pect­ed, spec­u­lat­ing that some unsu­per­vised patients had not coughed, which could have hin­dered per­for­mance.

The FDA told all labs grant­ed emer­gency use autho­riza­tions that they must not describe the tests as safe or effec­tive as they pro­mote them to cus­tomers, doc­tors and patients giv­en the trun­cat­ed review process.

Yet in pro­mo­tion­al mate­ri­als sent to poten­tial cus­tomers, Cura­tive describes the test’s “100% speci­fici­ty” and “90% clin­i­cal sen­si­tiv­i­ty.” A pro­mo­tion­al brochure [14] described the test as “exact” and said it had “accu­ra­cy greater than peers.”

And for months, until it was changed in late Jan­u­ary, Curative’s heav­i­ly accessed web­site said the test was “avail­able to all,” rather than spec­i­fy­ing the FDA had autho­rized it only for peo­ple with symp­toms of COVID-19.

Turn­er defend­ed the company’s mar­ket­ing, not­ing the emer­gency use autho­riza­tion is cit­ed on the web­site and that Cura­tive rec­om­mends that the test be used with­in its FDA-pro­scribed lim­i­ta­tions. He point­ed out that although the FDA reg­u­lates the mak­ers of diag­nos­tic tests, it has no pow­er over pub­lic health offi­cials who decide how the Cura­tive test is used, includ­ing for mass screen­ings of asymp­to­matic indi­vid­u­als. And he notes that no coro­n­avirus test is 100% accu­rate.

Many pub­lic health offi­cials, con­vinced that wide test­ing was key to keep­ing the pan­dem­ic in check, decid­ed to use Curative’s test beyond its lim­it­ed emer­gency use autho­riza­tion. In Los Ange­les, Chica­go and else­where, peo­ple could get test­ed even if they didn’t dis­play any clas­sic COVID-19 symp­toms, such as fever, cough­ing or lung con­ges­tion — often seek­ing per­mis­sion slips for work, trav­el or to see friends and fam­i­ly.

Seek­ing to expand its FDA autho­riza­tion, Cura­tive by Octo­ber had con­clud­ed a large clin­i­cal study par­tial­ly fund­ed by the Defense Depart­ment of 1,300 self-report­ed asymp­to­matic peo­ple who drove through sites in Los Ange­les and San Anto­nio.

The FDA was not pleased with the results, sub­mit­ted in Decem­ber, after con­duct­ing its own analy­sis of the study, accord­ing to emails obtained by BullDog.com [5], a Flori­da news out­let. Cura­tive and the FDA declined to release the emails to The Times.

An FDA review­er told the com­pa­ny a few days before Christ­mas that it found the test did not even appear to be accu­rate on symp­to­matic peo­ple, much less those with­out any symp­toms, accord­ing to Bull­Dog. Although Cura­tive pro­vid­ed addi­tion­al data to the FDA that Turn­er said dis­put­ed the analy­sis, the agency was unmoved and issued its safe­ty com­mu­ni­ca­tion.

The FDA state­ment did not fur­ther restrict the test, but reit­er­at­ed that it should be giv­en only to indi­vid­u­als who have had symp­toms with­in 14 days and under the direct obser­va­tion of trained health­care providers. It also repeat­ed that any neg­a­tive Cura­tive test does not rule out a coranavirus infec­tion and that providers should con­sid­er giv­ing their patients a dif­fer­ent test to con­firm results.

“We are warn­ing against false results if these pro­ce­dures are not fol­lowed,” Tim­o­thy Sten­zel, an FDA offi­cial, said dur­ing a nation­al con­fer­ence call soon after the advi­so­ry.

The com­pa­ny pub­lished a brief response that there had been no changes in “test per­for­mance” and that it would con­tin­ue to work with the FDA to pro­vide “addi­tion­al data required to address the lim­i­ta­tions and pre­cau­tions.” The response failed to reas­sure some rat­tled health­care providers.

A few days lat­er, L.A. Coun­ty offi­cials announced they would switch to anoth­er lab. Soon Cura­tive was also dropped by Col­orado. Pub­lic school offi­cials in New Orleans said they had sus­pend­ed the use of Cura­tive tests while Louisiana state offi­cials reviewed their accu­ra­cy. Sono­ma Coun­ty health offi­cials quick­ly warned res­i­dents about using a Cura­tive test if they did not have symp­toms.

Garcetti, how­ev­er, stood by the com­pa­ny, keep­ing the city’s large con­tract with Cura­tive in place.

“Our cus­tomers have large­ly remained with us and even expand­ed their rela­tion­ships in cer­tain cas­es, such as in the state of Delaware and River­side Coun­ty,” a Cura­tive spokes­woman said.

Anoth­er blow

Short­ly after the FDA’s Jan­u­ary warn­ing, the com­pa­ny found it had anoth­er prob­lem on its hands — qual­i­ty con­trol.

Admin­is­tra­tors at Columbine Health Sys­tems, which oper­ates nurs­ing homes and oth­er care facil­i­ties for old­er adults in north­ern Col­orado, were sur­prised when 27 employ­ees at one loca­tion test­ed pos­i­tive using Cura­tive in a sin­gle day. Then a week lat­er, 17 more employ­ees at anoth­er facil­i­ty test­ed pos­i­tive.

“We felt in our gut this doesn’t feel right,” said Myers, the direc­tor. So the next day, 16 employ­ees were retest­ed by Col­orado State Uni­ver­si­ty. Fif­teen were neg­a­tive, she said.

False pos­i­tive results are extreme­ly dan­ger­ous in a nurs­ing home, she said, because unin­fect­ed res­i­dents and employ­ees could be wrong­ly placed in a unit that cares only for those strick­en by the virus.

Col­orado offi­cials had required nurs­ing homes and oth­er facil­i­ties to use Curative’s tests since the sum­mer. By Jan­u­ary, Cura­tive was pro­cess­ing 70,000 tests in the state each week. Short­ly after Myers got state approval to use anoth­er lab, state offi­cials told oth­er facil­i­ties across Col­orado to stop using Cura­tive. They did not men­tion the prob­lems at Columbine, but instead cit­ed the FDA advi­so­ry.

A Cura­tive spokesper­son said the Columbine results were “an extreme­ly iso­lat­ed case of human error with a lab tech­ni­cian” and that the com­pa­ny had expe­ri­enced such prob­lems with only 0.02% of its results last year.

“In over 16 mil­lion tests, you’re going to have some per­cent­age of errors,” Turn­er said this year.

Rapid stud­ies

After review­ing the pub­lished sci­ence, the FDA and the CDC have said the nasopha­ryn­geal swab is the best at find­ing those infect­ed. In inter­views, Turn­er repeat­ed­ly said he believes his oral swab is accu­rate and that it is bet­ter than the nasopha­ryn­geal swab.

To prove that reg­u­la­tors were wrong, he got to work on sav­ing his empire by design­ing and car­ry­ing out two clin­i­cal stud­ies in weeks — an under­tak­ing that typ­i­cal­ly takes months or even years.

Cura­tive had been test­ing its own employ­ees and those of cer­tain ven­dors dai­ly as a safe­ty mea­sure. That made it pos­si­ble to pin­point when some got sick with COVID-19, allow­ing it to con­duct sep­a­rate stud­ies on those who had been recent­ly ill and those who were infect­ed ear­li­er.

Results sub­mit­ted to the FDA, the com­pa­ny said, sup­port the hypoth­e­sis that its test accu­rate­ly catch­es both symp­to­matic and asymp­to­matic peo­ple in the ear­ly stages when they are infec­tious, while the nasopha­ryn­geal test pro­duces more pos­i­tives lat­er because it picks up peo­ple shed­ding small amounts of virus when they are no longer infec­tious.

Turn­er said that the results explain how Curative’s test did not pre­vi­ous­ly per­form to the FDA’s sat­is­fac­tion — and why it chal­lenges the con­sen­sus that the nasopha­ryn­geal test should be the gold stan­dard COVID-19 diag­nos­tic.

That the­o­ry has some sup­port in the sci­en­tif­ic com­mu­ni­ty, includ­ing by Mina, who says oral flu­ids are bet­ter at telling peo­ple when they are actu­al­ly infec­tious. Turn­er also notes the Cen­ters for Dis­ease Con­trol and Pre­ven­tion [15] advis­es peo­ple that they can test pos­i­tive for COVID-19 months after the ill­ness has passed.

The results were her­ald­ed by some Cura­tive advo­cates, such as Rick Pesca­tore, chief physi­cian of the Delaware Depart­ment of Health, which expand­ed its part­ner­ship with the com­pa­ny despite the FDA advi­so­ry.

He tweet­ed [16] that the com­pa­ny had a “Big data release that shows how @Curative [17]‘s #COVID19 test­ing plat­form not only stacks up to but like­ly out­per­forms nasopha­ryn­geal sam­ples.”

The pos­i­tive recep­tion has not been uni­ver­sal for the com­pa­ny study, which more than two months lat­er has not been pub­lished in a peer-reviewed jour­nal.

Geof­frey Baird, a pro­fes­sor of lab med­i­cine and pathol­o­gy at the Uni­ver­si­ty of Wash­ing­ton, who reviewed the company’s FDA sub­mis­sion, dis­agreed with Curative’s the­o­ry that the patients with low viral loads picked up by a nasopha­ryn­geal swab were all no longer infec­tious.

“I’m still con­cerned that the over­all approach of doing oral flu­id test­ing lacks suf­fi­cient sen­si­tiv­i­ty and prob­a­bly will be miss­ing peo­ple who are infect­ed,” Baird said, not­ing sci­en­tists have yet to deter­mine the low thresh­old at which patients won’t spread the virus.

He said that Cura­tive had not pro­vid­ed enough infor­ma­tion in its fil­ing with the FDA for him to under­stand why its oral flu­ids test would sud­den­ly com­pare favor­ably to the nasopha­ryn­geal swab — a sharp change from ear­li­er tri­als.

“There’s obvi­ous­ly an enor­mous amount of mon­ey at stake here,” Baird said. “Is there any sec­ondary gain from con­tin­u­ing to push a test that may not have the best clin­i­cal sen­si­tiv­i­ty? I think the answer has to be yes.”

Uncer­tain future

Unlike most ven­ture-cap­i­tal-backed start-ups, Cura­tive found cus­tomers and rev­enue fast — but its future is as uncer­tain as the virus’ next muta­tion.

Last April, when the FDA award­ed Cura­tive its autho­riza­tion for emer­gency use, the start-up’s easy-to-admin­is­ter oral flu­id test filled a void. But now there’s com­pe­ti­tion from scores of com­pa­nies and a low­er demand for tests. Pub­lic health depart­ments spooked by the FDA’s safe­ty com­mu­ni­ca­tion had no trou­ble find­ing replace­ments.

Curative’s great­est achieve­ment by its own admis­sion was in the rapid admin­is­tra­tion and pro­cess­ing of tests and the dis­tri­b­u­tion of results.

“We don’t do any­thing mag­i­cal,” Turn­er said. “Real­ly there’s no new sci­en­tif­ic advances that we’ve come up with. We took the CDC test and got real­ly good run­ning it at scale.”

Cura­tive is now putting that exper­tise to use dis­trib­ut­ing vac­cines in five states, but that’s a frac­tion of the foot­print it had for its tests — and is yet anoth­er ser­vice with a lim­it­ed shelf life. Turn­er said the com­pa­ny is work­ing on oth­er projects in health­care and diag­nos­tics, though he declined to pro­vide details.

The out­come of those efforts will deter­mine whether Cura­tive was just a flash in the pan that took advan­tage of an extra­or­di­nary con­flu­ence of reduced reg­u­la­tions, a des­per­ate pub­lic sec­tor and plen­ti­ful gov­ern­ment fund­ing — or whether it can cre­ate a long-last­ing busi­ness.

Turner’s investors con­tin­ue to stand by him, with one call­ing him a “lab rat” who is a “no brain­er” to finan­cial­ly back. Turn­er, him­self, still holds out hope that the gov­ern­ment deter­mines that it was inap­pro­pri­ate to com­pare his company’s test against the nasopha­ryn­geal swab.

“Peo­ple don’t like to go back and admit that maybe that was not a cor­rect deci­sion,” Turn­er said, express­ing frus­tra­tion over the issue.

He’s not like­ly to get the last word in on that debate, though.

The FDA could recon­sid­er its safe­ty advi­so­ry on the nov­el COVID-19 test that Cura­tive has rid­den to fame, for­tune and, now, a share of noto­ri­ety — or sim­ply leave it in place.

———–