USA TODAY US Edition

RAPID, CHEAP HOME TESTS: COM­PA­NIES AT­TEMPT TO MAKE COVID-19 TESTS WIDELY AVAIL­ABLE

- Ken All­tucker and Ra­mon Padilla/USA TO­DAY Health · Pharmaceutical Industry · Medicine · Health Care · Industries · U.S. Food and Drug Administration · Johns Hopkins University · Hopkins · United States of America · Illinois · University of Miami · Philadelphia Union · United States Department of Health and Human Services · Cambridge, MA · Massachusetts · Cambridge · Boston · Abbott Laboratories · Rockefeller Foundation

Nearly two months af­ter fed­eral reg­u­la­tors un­veiled rules for at-home coro­n­avirus tests, no com­pany has fed­eral ap­proval to sell these fast and cheap tests even though the tech­nol­ogy is ready.

Molec­u­lar PCR tests pro­cessed at med­i­cal labs re­main the stan­dard of ac­cu­rate test­ing, but they are more ex­pen­sive and re­sults can take days to process.

Anti­gen tests are less ex­pen­sive, plen­ti­ful and de­liver re­sults in min­utes. Three com­pa­nies gained Food and Drug Ad­min­is­tra­tion au­tho­riza­tion to sell anti­gen test­ing ma­chines to labs or clin­ics. A fourth com­pany, Ab­bott Lab­o­ra­to­ries, won ap­proval to mar­ket a $5 rapid, credit card-sized test ad­min­is­tered by a health care pro­fes­sional.

But no com­pany has been cleared to sell tests di­rectly to con­sumers for wide­spread screen­ing – a step some be­lieve is nec­es­sary to slow the spread of COVID-19.

“The way to get this un­der con­trol is if peo­ple find out as early as pos­si­ble they are in­fected and then quar­an­tine from oth­ers,” said Dr. Yukari Man­abe, a Johns Hop­kins Univer­sity pro­fes­sor of medicine.

The United States needs 30 mil­lion tests a week to ad­e­quately track the virus, ac­cord­ing to the Rock­e­feller Foun­da­tion. Labs have worked round the clock and reached 1 mil­lion daily tests for the first time last week. That’s about one-quar­ter of Rock­e­feller’s goal of more than 4 mil­lion tests each day, ac­cord­ing to the COVID Track­ing Project.

Test­ing in many states is lim­ited to peo­ple ex­posed to the virus or sick. Rou­tine screen­ing could pre­vent the spread among peo­ple who have the virus but don’t have any symp­toms. If peo­ple test them­selves be­fore go­ing to work, restau­rants or school, it could sig­nif­i­cantly re­duce trans­mis­sion.

Rapid test stud­ies un­der­way

Illi­nois-based Ab­bott in Au­gust be­came the first com­pany to gain ap­proval of a rapid anti­gen test us­ing “lat­eral flow” tech­nol­ogy, sim­i­lar to a preg­nancy test. The U.S. Depart­ment of Health and Hu­man Ser­vices will spend $750 mil­lion to pur­chase 150 mil­lion tests with the first ship­ments ex­pected this month.

Gain­ing FDA au­tho­riza­tion for these in­ex­pen­sive, at-home tests is no easy task. The agency’s tem­plate says at-home tests should cor­rectly iden­tify pos­i­tive cases at least 90% of the time. This sen­si­tiv­ity thresh­old is higher than anti­gen tests the agency has au­tho­rized for point-of-care or lab set­tings.

The agency also wants com­pa­nies to con­duct stud­ies on how tests work on pa­tients. The FDA rec­om­mends stud­ies with at least 150 peo­ple, of which at least 30 peo­ple test pos­i­tive for the virus.

Cam­bridge, Mas­sachusetts-based, E25Bio is study­ing its anti­gen test on peo­ple with­out symp­toms at a co-work­ing space in the Bos­ton area. The com­pany al­ready has ap­plied to mar­ket its rapid anti­gen test as a di­ag­nos­tic that can be used at labs. The com­pany wants to gather enough data to ap­ply for at-home test­ing, said Car­los-Henri Ferré, E25Bio’s di­rec­tor of op­er­a­tions and com­mu­ni­ca­tions.

Ferré said the FDA's tem­plate for at-home test­ing re­quires a sen­si­tiv­ity level higher than other forms of anti­gen test­ing. “If we’re talk­ing about a screen­ing de­vice, the pa­ram­e­ters don’t need to be the same as an ul­ti­mate di­ag­nos­tic test,” he said. “We hope the (FDA’s) lan­guage would change and re­flect what we’re cre­at­ing, which is a screen­ing tool for pub­lic health.”

“If we’re talk­ing about a screen­ing de­vice, the pa­ram­e­ters don’t need to be the same as an ul­ti­mate di­ag­nos­tic test. We hope the (FDA’s) lan­guage would change and re­flect what we’re cre­at­ing, which is a screen­ing tool for pub­lic health.” Car­los-Henri Ferré, E25Bio’s di­rec­tor of op­er­a­tions and com­mu­ni­ca­tions

 ??  ?? 6. The virus RNA, mul­ti­plied mil­lions of times, makes it eas­ier to iden­tify. The data is plot­ted on a curve, and from that curve, re­sults are de­ter­mined.
6. The virus RNA, mul­ti­plied mil­lions of times, makes it eas­ier to iden­tify. The data is plot­ted on a curve, and from that curve, re­sults are de­ter­mined.

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