FDA Cutting Red Tape To Speed Development Of In-Home Tests; CRISPR Technology Gets Green Light From Agency
The agency's guidelines would help companies who are making kits that allow Americans to swab themselves and send the sample into a lab — all from the safety of their own home. Meanwhile, CRISPR technology could help cut testing time down to an hour. Meanwhile, as states grapple with testing questions, the porn industry could offer a template for moving forward.
The New York Times:
F.D.A. Paves Way For Home Testing Of Coronavirus
In a move that could significantly expand the nation’s testing capacity, the Food and Drug Administration has posted new guidelines that could pave the way for millions of people to test themselves for the coronavirus at home. The guidelines allow companies to develop and market testing kits with the tools to swab their noses and mail the specimens to any lab in the country. (Jacobs, 5/7)
The Washington Post:
FDA Gives Emergency Authorization For CRISPR-Based Diagnostic Tool For Coronavirus
The Food and Drug Administration on Thursday approved a new diagnostic tool that employs the revolutionary CRISPR gene-editing technology to determine in just one hour if someone is infected with the novel coronavirus. The FDA’s emergency use authorization allows only “high-complexity” laboratories to use the test kit, developed by researchers at the Massachusetts Institute of Technology, Harvard University, the Ragon Institute and the Howard Hughes Medical Institute and marketed by Sherlock Biosciences of Cambridge, Mass. (Achenbach and McGinley, 5/7)
Boston Globe:
Cambridge Biotech’s Virus Test Using CRISPR Gene Editing OK’d For Crisis
A Cambridge biotech startup received emergency clearance Thursday for a faster and radically different laboratory test to diagnose COVID-19, a kit the company says can give results within an hour. The Food and Drug Administration provided an “emergency use authorization” for the test made by Sherlock Biosciences. It relies on the revolutionary genome-editing tool CRISPR, which edits DNA and has the potential to treat a vast array of diseases but had yet to win FDA approval for any product. The tool was repurposed to create a diagnostic test. (Saltzman, 5/7)
Stat:
Could The Porn Industry Offer A Model For Reopening Amid Covid-19?
As states and employers furiously develop plans to safely reopen workplaces in the midst of the coronavirus pandemic, they’re grappling with what seems like an endless list of questions: where to test, who to test, and how often to test for the virus? Further complicating matters are issues of workers’ privacy, geography, politics, science, and cost. It’s a difficult mandate. But there is one place to look for guidance — the adult film industry. (McFarling, 5/8)
CNN:
Coronavirus: Rollout Of Antibody Tests Met With Confusion, Little Oversight
Public health experts, including members of the White House Coronavirus Task Force, have argued accurate Covid-19 antibody tests can support efforts to get Americans back to work by determining who may have overcome the virus. But the rollout of millions of antibody tests in the US has created frustration and division among state health departments due to a mix of questionable tests, shifting federal rules and a hodgepodge of different methods for tracking results. (Devine, Bronstein and Griffin, 5/7)
Kaiser Health News:
Trying Out LA’s New Coronavirus Testing Regime
Last week, after Mayor Eric Garcetti announced that Los Angeles was offering COVID-19 tests to all city and county residents, I decided to get one myself — and test Garcetti’s bold new promise in the bargain. I was surprised how easily I was able to log on to L.A.’s testing website. I answered a few questions about myself, including whether I had any symptoms of the disease — the answer was no — and within three minutes, I had a same-day appointment at one of eight city-run testing sites. (Wolfson, 5/8)
San Francisco Chronicle:
California Clinics, Counties Get $97 Million From Feds To Expand Testing
The U.S. Department of Health and Human Services has awarded $97.3 million to 179 California health centers to expand coronavirus testing in low-income communities, the federal agency said Thursday. The grants are part of $583 million the federal government is distributing to 1,385 health centers that receive funding from the Health Resources and Services Administration, a unit of HHS that seeks to improve health care access for uninsured and vulnerable Americans. The money comes from the federal Paycheck Protection Program and Health Care Enhancement Act, which provides funding for small businesses hurt by the pandemic and economic support for health care providers and testing efforts. (Ho, 5/7)
Atlanta Journal-Constitution:
Governor Urges All Georgians To Get Testing For Coronavirus
Gov. Brian Kemp urged all Georgians to schedule an appointment for coronavirus screening regardless of whether they have symptoms, as the state continues to expand testing for the disease even as the rapid growth has exposed new strains. With the state no longer facing crippling shortages of key supplies, Kemp said Thursday that the capacity for testing now outstrips the public’s demand in the weeks after he began to reopen parts of the economy. That has stressed area labs, however, struggling to keep up with record numbers of tests. (Bluestein and Hallerman, 5/7)
Atlanta Journal-Constitution:
Ga. Heath Centers To Receive More Than $12.2 Million For COVID Testing
Nearly three dozen health centers in Georgia will share more than $12.2 million in federal dollars to expand testing for COVID-19. This infusion of funding is part of nearly $583 million awarded across the U.S. and its territories by the U.S. Department of Health and Human Services to boost testing capacity. The money is going to centers funded by its Health Resources and Services Administration, which provide health care services to populations that have limited access to health care services. (Mariano, 5/7)
Boston Globe:
Maine To Triple Testing Capacity For Coronavirus
Maine Governor Janet Mills announced a partnership with IDEXX Laboratories, a local manufacturer, which will allow the state to more than triple its testing capacity in the coming weeks and remove testing criteria for those who believe they may have the virus. The public-private partnership will introduce a new diagnostic testing system to the state’s health department and bolster the state’s testing 2,000 tests per week to 7,000 tests per week “for the foreseeable future,” Mills said at a press conference Thursday afternoon. IDEXX is also lending 3,500 test kits to the state’s health department. (Berg, 5/7)