The surge of interest in testing for the COVID-19 pathogen has led to some innovative tests and test strategies, including at-home tests. However, the FDA has indicated that it is wary of both at-home testing and specimen collection in other than supervised settings, a policy that is meeting with criticism from some quarters, but not all.
Everlywell Inc., of Austin, Texas, had announced March 18 that it had a test kit available for shipment that would have permitted at-home collection of samples that could have been analyzed via telehealth. The company indicated it had 30,000 such kits available, but the company had to withdraw the direct-to-consumer offer. The kits are available to health care professionals.
Among the companies that have shelved plans to distribute kits to consumers is Nurx Inc., of San Francisco, which had partnered with Molecular Testing Labs of Vancouver, Washington, to develop the tests. Other firms have flirted with the at-home market for these tests, including Carbon Health, also of San Francisco, which likewise stood down a similar plan.
The FDA discussed briefly its position on at-home testing in a FAQ for coronavirus diagnostics, stating that its policy for COVID-19 testing excluded at-home testing and self-collection samples. The agency encouraged developers to discuss their validation efforts for such tests “early in their development process.”
Danielle Bradnan, an associate with Lux Research Inc., of New York, described the FDA’s position as "baffling.” Bradnan said that while the FDA “is trying to achieve a delicate balance, trying to facilitate as many tests as possible while ensuring safety and accuracy, it is unclear why it is doing this.”
Test samples must be shipped to an independent, CLIA-certified lab for many test collection sites, Bradnan said, adding that the process in question “is identical to the process of at-home testing companies, which mainly serve as infrastructural support for sampling.” The agency has previously taken a largely hands-off approach for similar testing protocols, including those for allergies and fertility testing, she said, a history that renders the current policy difficult to comprehend.
Mark Gardner, president of Gardner Law of Stillwater, Minn., told BioWorld that the FDA’s concern remains that these tests be properly validated. “That’s something that really can’t or should be rushed,” he said, adding that the commercial labs that are now offering tests for the COVID-19 outbreak have provided extensive documentation of their validation efforts. This includes repeat testing to ensure the validity and reliability of their tests in the hands of the type of practitioners who would be handling those tests. All things considered, Gardner said, “I think we’re a way off from a home kit.”
The FDA is under the microscope regarding its response to this and other considerations connected with the COVID-19 outbreak, but Gardner said the agency is unlikely to change its mind. “I don’t think they’ll buckle, but they are under a tremendous amount of pressure” to move quickly, he said, adding that there may be some upcoming developments related to reviews of 510(k)s for well-understood items such as N95 masks. “If it’s super-well characterized, I think we’re going to see some loosening up there. It depends on each device type,” however, he said.
The difficulty with anything connected to diagnostics is that a false negative return is a huge problem, so the agency must balance access with test reliability, precision and accuracy, which are critical. The FDA is still convinced it must observe those concerns, “or you could do more damage than good.”
Cuomo says ventilators, hospital capacity under pressure
New York Governor Andrew Cuomo said in a March 25 briefing that the number of diagnoses in the metropolitan New York area continues to rise, and that it does not appear to have peaked. Roughly 80% of cases have self-resolved, and 15% of positive tests require hospitalization of some sort. Cuomo said the rate of hospitalizations in New York City has exceeded predictions, thus consuming more hospital supplies and space than anticipated. About 140,000 cases have been admitted to hospitals, with only about 53,000 beds. Roughly 40,000 intensive care unit (ICU) cases are competing for only 3,000 or so ICU beds.
These last numbers are important in terms of the need for ventilators, Cuomo said, adding that population density control measures may be working to slow the spread of the COVID-19 virus, as evidenced by a slowing of the rate of doubling of hospital admissions. This doubling of admission occurred every two days up to March 22, but that doubling rate fell to every 4.7 days by March 24. “That is almost too good to be true,” Cuomo said, vowing that “the arrows are headed in the right direction.”
The peak need for hospital capacity in New York may arrive in roughly 21 days, a projection Cuomo said shifts with the arrival of new data. Cuomo issued an executive order that grants all health care professionals legal immunity from civil liability for any injury or death as a result of treatment, or omission thereof, while providing services during the COVID-19 pandemic.
Cuomo said New York needs 30,000 ventilators, adding that the state has purchased 7,000 units and the U.S. federal government has sent another 4,000. He said hospitals in the state are exploring a modification that would allow the use of a single ventilator for two patients, adding, “that is our single greatest challenge, the ventilators.”
Despite criticism of the Trump administration’s decision not to use the Defense Production Act (DPA) to conscript manufacturing capacity, Cuomo said “the President and his team are using the DPA well.” Cuomo said the DPA is tremendously useful as leverage, but “even with that, there’s a ramp-up time for a company” to stand up a supply chain and get workers in place to produce articles as complex as ventilators. To move all these resources into place in sufficient numbers to produce and deliver 30,000 ventilators “is an extraordinarily difficult task,” he said.
Two Senate Democrats had called on the Trump administration to operationalize the DPA as a means of boosting availability of the needed items, but rumors that Peter Gaynor, administrator of the Federal Emergency Management Agency (FEMA), would do so proved incorrect. FEMA press officials advised BioWorld in an evening March 24 email that the agency had determined that no such action was necessary for diagnostic testing supplies as the private sector had acted to fulfill that need without being forced.
The push for innovation in response to the crisis is taking place at the hospital level, as indicated by a March 25 update by Columbia University Hospital in New York. The update said that an effort to re-sterilize N95 masks and other items via dry heat have been successful, as has re-sterilization of face shields manufactured by additive manufacturing, but the hospital is also using a ventilator to handle two patients as discussed by Cuomo. The hospital has the capacity to conduct 1,000 antigen tests per day with polymerase chain reaction systems, but transfer media, swabs, and personal protective equipment are insufficient to utilize that entire capacity.
Dems, Republicans wrangling over $2 trillion package
The U.S. Senate was still working on resolving differences in the spending package to provide economic relief for American citizens and businesses, but the broad outlines of the package were in sight the afternoon of March 25. Still, Senate Democrats and Republicans were in talks with the Trump administration on the details of a deal, although a Senate vote was still not underway by press time March 25.
Sen. Chuck Schumer (D-N.Y.) said H.R. 748, the CARES Act, is analogous to the Marshall Plan used to resurrect the European economy after World War II. Schumer said the bill would send $150 billion to hospitals and medical system, including $100 billion specifically for COVID-19. These monies “will literally act as a lifeline as the number of COVID-19 cases continues to climb,” he said.
Another $16 billion would be used to replenish the Strategic National Stockpile for pharmaceuticals, personal protective equipment and other supplies. The Biomedical Advanced Research and Development Authority would take in $3.5 billion to be applied toward production of therapies, vaccines and diagnostics. A bolus of $1 billion would be applied toward purchases of various supplies and equipment under the DPA, while FEMA would receive $45 billion for disaster relief funding.