The U.S. FDA reported that it has expanded the emergency use authorization for the Labcorp polymerase chain reaction (PCR) test for SARS-CoV-2 to include the company’s Pixel self-collection kit, a development that may presage a wider testing paradigm that is needed to restore the U.S. economy to normalcy. Labcorp, of Burlington, N.C., explained in an accompanying statement, however, that the Pixel kits will be available to only health care workers and first responders in the early going. It will be available to consumers “in the coming weeks.”
For his part, FDA Commissioner Stephen Hahn said that the agency had worked with the company to ensure that the Pixel system “is as safe and accurate as sample collection at a doctor’s office.” The agency went on to note that the kit consists of a swab and saline, but that concerns regarding cross-reactivity and sterility have led it to determine that other cotton swabs should not be used with the company’s PCR test at present. The FDA also is collaborating with test developers to determine whether “Q-tip-style cotton swab[s] can be used safely and effectively with other tests.”
The agency also noted that the Pixel only will become available to broader populations in the U.S. in the weeks to come, but as is the case with the Labcorp press release, the FDA statement lacked specifics. The FDA announced April 16, however, that spun synthetic swabs bearing a design resemblance to Q-tips may be used to obtain samples from the “front of the nose.” The announcement indicated that U.S. Cotton, of Gastonia, N.C., had developed a polyester-based swab that is compatible with testing for the SARS-CoV-2 virus.
Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, had indicated during an April 15 stakeholder briefing that a home sample collection kit was in the works, although he declined to offer details. “We do think it’s going to happen very soon,” Stenzel explained at the time, adding that the agency was in conversations with developers on a home-based test in addition to a home swab sampling kit. However, he did not give any indication as to when a home-based test might become available.
Labcorp was unable to provide a spokesperson for comment.
The FDA has been criticized for its approach to authorizing tests for the pandemic, but it is not the only global regulatory body that has struggled to cope under the extraordinary circumstances. Health Canada (HC) issued an interim order in mid-March addressing the importation and sale of kits and related supplies, leaning as the FDA has on a temporary waiver of the usual regulatory requirements. At present, HC has authorized the use of 13 tests for the pathogen, including several obtained from developers in South Korea. Australia’s Therapeutic Goods Administration has a list of nearly 40 test kits that are on the Australian Register of Therapeutic Goods. More than half of these kits, as well as point-of-care tests, are from China.
HHS unveils HIPAA discretion policy
Other agencies and departments of the U.S. government have been at the forefront of the pandemic response, including the Department of Health and Human Services (HHS), which said April 20 that it would exercise enforcement discretion regarding violations of patient privacy regulations. The HHS Office of Civil Rights said the policy applies to violations of the terms of the Health Insurance Portability and Accountability Act incurred during “good-faith” efforts to provide telehealth services. Health care professionals will be able to use nonapproved technologies for interacting with patients, such as Zoom, even for non-COVID-19 cases. Several applications do not fall under the terms of this policy, however, such as Facebook Live and Tiktok.
The Centers for Medicare & Medicaid Services (CMS) has made several moves to support beneficiaries during the COVID-19 pandemic. It announced April 20 that one Medicare incentive program will be tweaked to encourage reporting of outcomes of patients in clinical trials for the pandemic. The policy requires that clinicians attest to participation in a study of a drug or biologic to treat COVID-19 and report findings through a repository or data registry for the duration of the study.
CMS said the policy covers randomized, controlled studies using placebos, and participating physicians can earn half the total credit needed to earn a maximum score under the Merit-based Incentive Payment System (MIPS). NIH-conducted studies are eligible, as are those using the COVID-19 Therapeutic Learning System developed by Oracle Corp., of Redwood City, Calif. That mechanism is available to health care professionals at no charge, and CMS said the use of an open-source reporting mechanism may accelerate reporting of outcomes sufficiently to align care with the accumulating evidence.
Also of note, both U.S. Centers for Disease Control and Prevention (CDC) and public health labs have processed nearly 394,000 tests. Slightly more than 5,000 of those have been handled by CDC labs. The agency noted that as of March 12, the reported volumes reflect the date of specimen receipt rather than the date of specimen collection. However, nonrespiratory specimens are not included in this tally.
Cowen: PCR testing may meet demand by June
Cowen Washington Research Group posted an April 21 update stating that molecular testing capacity in the U.S. should be “sufficient enough” to meet clinical demand by the end of June and should be in time for a second wave in autumn. The report noted that high-volume serological testing should likewise be up to speed sufficiently to assess exposure to the pathogen by mid-June; however, the report casts doubt as to whether availability of both categories of test will allow a full reopening of the U.S. economy.
The report added that the total addressable market for these tests may be $2 billion to $3 billion by the end of the upcoming flu season, and that incremental demand beyond that point likely will be considerable. Makers of molecular testing systems and supplies “are likely to sell whatever maximum capacity is over the next 3-9 months,” according to the report. However, there is still the risk that supplies of collection tubes, swabs, transport media and reagents will represent rate-limiting factors.