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A rapid scale-up of diagnostic testing for the novel coronavirus was the focus of a declaration of emergency by President Donald Trump in a March 13 press conference. The plan calls for sharply boosting the production of coronavirus test kits while also making tests available at a network of drive-through sites.

In an address at the White House Rose Garden, Trump announced a series of sweeping measures designed to eliminate government regulations that may have been hindering the federal response to the coronavirus outbreak. Most of Trump’s address was devoted to the administration’s plans for making diagnostic testing more available across the country — an issue that has become a flash point for criticism of the administration’s response to the virus.

In his emergency declaration, Trump said that previous government regulation included “very old and obsolete” rules. The new declaration would enable the U.S. Department of Health and Human Services (HHS) to waive rules that may have impeded hospitals and healthcare providers from responding adequately to the coronavirus outbreak. The declaration would also make available $50 billion in federal funding to fight the outbreak.

But Trump reserved the lion’s share of his speech to explain what the administration is doing to make diagnostic test kits more available to test for SARS-CoV-2. Healthcare providers and clinical labs in the field have complained that they have not had enough coronavirus tests available to meet demand, and some have claimed that testing criteria have been too restrictive.

The new plan relies on a combination of making more testing capacity available and at the same time making it easier for Americans to get tested, such as with drive-through testing sites. The administration is also working with Google to set up a website that will enable Americans to determine on their own whether they should seek out testing.

With respect to testing capacity, Trump explained the work the administration has been doing with diagnostics manufacturers such as Roche and Thermo Fisher that builds on a meeting between diagnostics vendors and the government last week.

Roche developed a high-throughput test for the coronavirus, cobas SARS-CoV-2, that received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) within 24 hours of submission of an application. The test’s high-volume capacity should be a step forward in meeting demand for coronavirus testing, Trump said.

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Molecular point-of-care diagnostic solutions offer improvements in the sensitivity and specificity of existing near-patient and rapid tests while expanding the diagnostic capabilities at points of care, such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world, and are used to assess conditions or admit patients.  The concept of molecular point of care is to mix the accessibility of POC testing with the accuracy of molecular technology. Kalorama has covered molecular point of care on a yearly or biyearly basis since 2013. Our latest report found slower system adoption, but brisk consumables sales and the continued hope of test menu expansion.

The molecular point of care segment, the focus of the report, includes only the small/ portable models and defines the molecular POC/ near-POC market as:

  • Systems that are CLIA-waived, or could soon have or potentially have the capability for running CLIA-waived tests.
  • Systems that can run moderate-complexity or high-complexity tests in a decentralized setting such as a non-laboratory area of a hospital or a physician office/ clinic visit.
  • Tests with a short waiting period for the results, making it practical and useful for POC.

This may differ from other definitions of point of care.  The mPOC systems have great sensitivity and scalability, and they won over early adopters but have had difficulty making the case for routine adoption.  As was asked at the Association for Molecular Pathology (AMP) meeting panels last year: Is the juice worth the squeeze? And there’s not a true answer yet. These systems will have to prove to gain new placements.

“Our latest report found slower system adoption, but brisk consumables sales and the continued hope of test menu expansion.”

The overall revenues estimate for this “true” mPOC segment is provided below. This segment is largely made up of tests for the flu and other respiratory diseases.    However, they are earning consumables sales from the placements they have.  As presented, the revenues for this segment are forecast to increase from $360 million to $852 million between 2019 and 2024, with a compound annual growth (CAGR) of 18.8%.

Kalorama also details another segment: more than $2 billion of “near-patient” systems that are not aimed at decentralized testing areas and require users to have technical competency.

Molecular systems need to prove marginal worthiness in the clinical setting as they have a higher cost.    Molecular tests tend to have much higher sensitivity and specificity, even 100%, but lab-based nucleic acid amplification tests were historically slower and required more expertise to run. Now with mPOC systems, the question will turn on marginal difference in sensitivity over immunoassay systems, and this will be driven by journal literature and clinical practice changes.

Justification for purchases of molecular point-of-care instruments and reagents are dependent on the argument of superior sensitivity and specificity. In this regard, the findings from a January 2020 Journal of Clinical Microbiology study are welcome news.  Major CLIA-waived mPOC systems were compared with immunoassay systems. Molecular had high-90s sensitivity, whereas the tested immunoassay system had high sensitivity of 80% and a sensitivity for influenza B of 67%. Not being able to establish a “true-negative” test has been a frustration of providers using rapid immunoassay tests.

 

March 9, 2020 — The revival of legislation to change the regulation of laboratory-developed tests (LDTs) has drawn a mixed response. The reintroduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act is intended to remove barriers that are believed to have impeded the U.S. government’s response to the coronavirus epidemic.

The issue of diagnostics regulation has emerged as a political lightning rod, with some faulting the Trump administration’s response to the outbreak and others blaming what they claim is a history of federal overregulation of clinical labs.

“The industry associations that produce commercial IVD kits and pathologists who are concerned about overcommercialization of lab tests are clashing with representatives of the laboratories themselves.  These opinions represent longstanding positions of the players.”

Clinical labs are regulated by the U.S. Centers for Medicare and Medicaid Services (CMS) under CLIA and are not typically subject to oversight by the Food and Drug Administration (FDA). However, the FDA does regulate individual diagnostic tests, with diagnostic manufacturers required to gain FDA approval to market their assays. Yet another regulatory category, laboratory-developed tests, are tests that labs can develop and use on their own.

The situation has created several hurdles in responding to the novel coronavirus. When the FDA declared the coronavirus a public health emergency, it triggered a requirement that labs in the field get the FDA’s blessing to use their LDTs for the virus. The FDA subsequently waived this rule on February 29, but the need for a permanent solution to the regulatory environment is apparent…

To read more, please visit LabPulse.com: https://www.labpulse.com/index.aspx?sec=sup&sub=lab&pag=dis&ItemID=800854