Senator Says Roche Needs to Make Ensuring Minnesota Department of Health, Public Health Labs Across the Country Have Ability to Increase Testing Capacity a Top Priority

WASHINGTON, D.C. [03/25/20]—Today, U.S. Senator Tina Smith (D-Minn.) pressed Roche Diagnostics to supply the vital reagent—which is a solution critical for coronavirus testing—that public health laboratories need in order to increase testing capacity. Sen. Smith has heard from the Minnesota Department of Health that it is quickly running out of reagents and diagnostic kits needed to keep up with demand.

While the Centers for Disease Control and Prevention (CDC) has been able to issue COVID-19 test kits, testing requires additional reagents that are not provided by the CDC. Roche Diagnostics has developed a reagent system that would enable labs to increase testing capacity, but the company is not prioritizing this system. Currently, Roche is instead pushing a test that requires specialized equipment, which most public health labs—including Minnesota’s—cannot afford. Sen. Smith is standing up for Minnesotans and Americans across the country by urging Roche to reverse course and instead make the test public health labs need a top priority.

“With help from the private sector, CDC was able to issue COVID-19 test kits. However, testing requires additional reagents that are not provided by CDC. The Roche MagnaPure 96 extraction platform is possibly the single most important system that would enable public health laboratories to increase testing capacity. The Minnesota Department of Health verified this platform for use with the CDC assay but has been unable to get reagents and consumables for the platform, including filter tips and, most recently, cartridges. We are aware that public health laboratories across the nation are faced with these same shortages,” wrote Sen. Smith to Roche CEO Severin Schwan. “On March 12, Roche received FDA’s first Emergency Use Authorization (EUA), which allowed unapproved COVID-19 diagnostic tests to be used during this public health emergency. This test, called cobas SARS-CoV-2, requires highly specialized machinery to process a high-throughput detection assay. Most public health laboratories, including Minnesota’s, cannot afford such specialized equipment.”

Sen. Smith continued “It’s my understanding that Roche has prioritized the cobas SARS-CoV-2 test, abandoning tests and supplies for public health laboratories. Because of this, Minnesota has to limit testing to priority groups, such as hospitalized patients and health care workers, limiting the ability of Minnesota to conduct community surveillance. Roche is now presented with the opportunity to reverse course. In the interest of my constituents and Americans across the country, I urge you to do everything you can to supply the reagent that public health labs need, fill the hole in testing capacity at public health labs, and deliver our nation the ability to run on full capacity to test for COVID-19.”

You can access full text of the letter here or below:

March 25, 2020

Severin Schwan

Chief Executive Officer

Roche Diagnostics

9115 Hague Road

PO Box 50457

Indianapolis, IN 46250

Dear Dr. Severin Schwan:

I write to express my serious concern regarding the lack of COVID-19 diagnostic tests available for use by state public health laboratories. We have heard from the Minnesota Department of Health that they are quickly running out of the reagents and diagnostic kits to keep up with increasing testing demands. I plead with you to make up for this shortage and supply the reagent that public health laboratories need.

On January 24, 2020, the Centers for Disease Control and Prevention (CDC) announced the details of their own COVID-19 diagnostic test. On February 4, two weeks after the first case of COVID-19 was reported in the United States, this test was finally approved. On February 6, CDC shipped out 90 test kits to state public health laboratories so they could immediately run 400 tests each, or 36,000 tests total. Unfortunately, these tests were invalidated by public health laboratories and found to include a defective reagent.

With help from the private sector, CDC was able to issue COVID-19 test kits. However, testing requires additional reagents that are not provided by CDC. The Roche MagnaPure 96 extraction platform is possibly the single most important system that would enable public health laboratories to increase testing capacity. The Minnesota Department of Health verified this platform for use with the CDC assay but has been unable to get reagents and consumables for the platform, including filter tips and, most recently, cartridges. We are aware that public health laboratories across the nation are faced with these same shortages.

On March 12, Roche received FDA’s first Emergency Use Authorization (EUA), which allowed unapproved COVID-19 diagnostic tests to be used during this public health emergency. This test, called cobas SARS-CoV-2, requires highly specialized machinery to process a high-throughput detection assay. Most public health laboratories, including Minnesota’s, cannot afford such specialized equipment.

It’s my understanding that Roche has prioritized the cobas SARS-CoV-2 test, abandoning tests and supplies for public health laboratories. Because of this, Minnesota has to limit testing to priority groups, such as hospitalized patients and health care workers, limiting the ability of Minnesota to conduct community surveillance.

Roche is now presented with the opportunity to reverse course. In the interest of my constituents and Americans across the country, I urge you to do everything you can to supply the reagent that public health labs need, fill the hole in testing capacity at public health labs, and deliver our nation the ability to run on full capacity to test for COVID-19.

Sincerely,

Issues