Top News Stories for the Week of March 2

As Coronavirus Numbers Rise, CDC Testing Comes Under Fire

New York Times

The coronavirus has exposed problems with diagnostic testing in the United States. The Centers for Disease Control and Prevention failed in its first attempt to mass produce a diagnostic test kit, a discovery made only after officials had shipped hundreds of kits to state laboratories. A replacement took several weeks, and still did not permit state and local laboratories to make final diagnoses. Critics say CDC also imposed such stringent and narrow criteria that Americans would be tested in very few numbers. Trump administration officials on Monday promised a rapid expansion of the country's testing capacities. With the help of private companies and academic centers, as many as a million diagnostic tests could be administered by the end of this week, said FDA Commissioner Stephen Hahn, though many scientists have expressed concern the moves come too late. As of Monday evening, 103 Americans were infected with the coronavirus in the United States. Six deaths have been reported. Dozens of patients, in several states, may have caught the virus in their communities, suggesting that the pathogen already may be circulating locally. "Clearly, there have been problems with rolling out the test," said Thomas Frieden, former director of CDC. "There are a lot of frustrated doctors and patients and health departments." However, Frieden said he thought the situation was improving.

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FDA Finalizes Guidances on CLIA Waiver Applications, 510(k) Dual Submissions

Regulatory Focus

Two guidance documents from the Food and Drug Administration (FDA) finalized recommendation for diagnostics makers that want to submit Clinical Laboratories Improvement Amendments (CLIA) waivers for their tests or conduct studies to support dual 510(k) and CLIA waiver by application submissions. Regarding FDA's final guidance on CLIA waiver applications, the agency says: "This final guidance provides additional and updated approaches for demonstrating that a test meets the statutory criteria for waiver and includes FDA's revised thinking regarding 'the appropriate use of comparable performance between a waived user and a moderately complex laboratory user to demonstrate accuracy.'" FDA says the remainder of the guidance is generally unchanged from the 2008 version except for "technical edits for consistency" in other sections. Meanwhile, FDA's final guidance on studies needed to support a dual 510(k) and CLIA waiver by application submission is largely the same as the revised draft version released in 2018. FDA discusses how to submit a dual submission and the study design considerations an in vitro diagnostic test developer should make to support both applications. FDA notes, "Use of the dual 510(k) and CLIA waiver by application pathway is optional; however, FDA believes this pathway is in many instances the least burdensome and fastest approach for manufacturers to obtain a CLIA waiver and at the same time as 510(k) clearance."

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First U.S. Attempt at CRISPR Gene Editing in Cancer Appears Safe

Reuters Health

A study published in Science suggests that using the CRISPR-Cas9 gene-editing tool in cancer is safe. Researchers led by Edward Stadtmauer, MD, of the University of Pennsylvania, gathered immune system cells from the patients' blood and used the CRISPR-Cas9 system to remove genes from the cells that might impede the immune system's ability to fight cancer, and engineered T-cells to recognize and attack cancer cells. The team then infused the T-cells back into the patients, and found that they started growing in all of the patients and lasted for up to nine months. The pilot study was intended to monitor safety; more extensive trials will be needed to test for efficacy. At the end of the trial, one patient died from advanced cancer, and the other two were receiving other treatments. One concern with CRISPR-edited cells is that the technique may lead to "off-target" edits in the genome. Study co-author Carl June, MD, an immunologist at the University of Pennsylvania who pioneered CAR-T cell therapy, says the team found two off-target effects. One was a rare change in the DNA code that occurred in 1 in 1,000 of the edited cells, and the other was a chromosome translocation that occurred in fewer than 1.5 percent of the infused cells. The infused cells with these unintended edits did not survive as well as the correctly edited genes, June says. However, he expects that many academic centers and companies will test the technique in other clinical trials.

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