White House proposes two antibody tests per patient in updated COVID-19 plan

The Trump administration has posted an update to its plan to reopen the U.S. economy, this time with a slightly different twist on testing. This plan not only calls on local governments to administer tests for the SARS-CoV-2 virus, but also calls for two antibody tests per person under some circumstances, an approach that should beef up both the positive and negative predictive values compared to a single antibody test.

The Trump administration rolled out the 15-day social distancing policy roughly six weeks ago, at which time several test makers had won an emergency use authorization for their tests. An overview of the new approach states that the FDA had listed 62 molecular tests and another eight serological tests under the agency’s testing EUA, and that 5 million tests had been completed in the U.S. as of April 26. The overview further makes note of antigen testing and genomic sequencing technologies as two other methods for surveillance and diagnosis.

The new blueprint states that among the core principles is that testing plans and rapid-response programs “will be federally supported, state managed and locally executed.” The states are liable for developing their own plans per the “unique circumstances and challenges” seen in that state, but those plans should address the availability of a “timely and accurate diagnostic test” for every symptomatic patient. The framework also calls for an assessment of community spread as assessed via sentinel monitoring at “critical locations,” such as nursing homes. This monitoring process would involve testing of asymptomatic individuals, which would be accompanied by contact tracing as well.

Among the surveillance systems available to state administrators are the Influenza-Like Illness Surveillance Network and the National Syndromic Surveillance Program, both of which are under the administration of the CDC. This effort will require more widespread nucleic acid testing at the point of care (POC) as well as POC antigen testing, although antibody testing will still be crucial in efforts to establish local infection rates, particularly among first responders, health care professionals and “vulnerable populations.”

President Donald Trump unveiled the revised policy in an April 27 briefing at the White House, which was preceded by a meeting with leaders of a number of entities, including Julie Khani, president and CEO of the American Clinical Laboratory Association. Khani said in an April 27 statement that ACLA member labs have conducted 3.2 million tests since the outbreak began, and that those labs would continue to focus on boosting capacity for both molecular and serological tests. Khani urged the administration to set aside a portion of the $25 billion test fund recently provided by Congress to “provide direct support to laboratories” performing testing for the COVID-19 outbreak.

The FDA’s series of policy guidances for enforcement discretion has encompassed a number of product areas, including the enforcement discretion for imaging systems that is in force for the duration of the public emergency declaration. The Medical Imaging & Technology Alliance (MITA) said in a March 26 letter to the FDA that the agency should “temporarily prioritize” the premarket review of medical imaging systems needed during the pandemic, and to give manufacturers more regulatory leeway to convert static imaging systems for mobile use.

MITA said in an April 28 statement that it supported the enforcement discretion policy, which the association said would boost the availability of mobile medical imaging. Patrick Hope, MITA’s executive director, said the policy will enable delivery of imaging systems to locations where the need is most urgent, and MITA said that additional flexibility is also built in for ultrasound and conventional X-ray systems as well.

Other considerations resurfacing

The COVID-19 pandemic has for the past several months overwritten other health care policy considerations, but the Advanced Medical Technology Association (Advamed) is one of several groups that is pushing for measures to ensure cancer patients have access to radiotherapy. Advamed is one of several members of the Global Coalition for Radiotherapy, which was formed to address the problems cancer patients are having gaining access to this therapeutic modality.

The coalition said that radiotherapy is involved in 40% of cancer cures despite being overshadowed by the latest pharmaceutical therapy, adding that delays in diagnosis will “result in stage migration.” The picture grows grimmer as the effects of the pandemic trigger a backlog of demand for radiotherapy, they said.

Enforcement also on tap

U.S. federal agencies are keeping track of private sector activities, such as filing Medicare claims for unnecessary tests billed to Medicare and other federal health plans. Asheville, N.C.-based Genova Diagnostics Inc., is said to have agreed to pony up as much as $43 million to address alleged unnecessary testing for several purposes, including for immunoglobulin G, one of the three major markers of interest where serological testing for the SARS-CoV-2 virus is concerned. Genova will enter into a five-year corporate integrity agreement with the Office of Inspector General at HHS, and the qui tam action included allegations that Genova paid compensation to three phlebotomy vendors to prescribe testing. The settlement calls for $17 million to be paid up front, and as much as another $26 million, depending on whether “certain financial contingencies occur within the next five years.” Corporate integrity agreements typically run for a term of five years.

The U.S. Postal Service has declared that it will require shippers of tests and related materials to obtain authorization prior to mailing such items. The associated Federal Register notice, dated April 29 but appearing in the prepublication version, listed April 27 as the effective date of the requirement, adding that the concern revolves largely around the prospect that shipped items will be sufficiently jostled to expose others to any pathogens.

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