Dive Brief:

• The Department of Health and Human Services on Thursday announced $6.5 million for two commercial laboratories, Aegis Sciences and Sonic Healthcare, to enable the U.S. to perform an additional 1 million tests per week by early October — with the goal of adding up to 4 million additional tests per month.
• The funds for Aegis and Sonic, both members of the American Clinical Laboratory Association, will provide them with lab equipment from Beckman Coulter and Thermo Fisher as well as help increase staffing and infrastructure needed to expand testing capacity.  
• Assistant Secretary for Health Brett Giroir said the investment will connect instruments and reagents with commercial labs, although "not every laboratory can get the exact reagent they want." The funding comes after seven lab and provider organizations in a letter to HHS this week urged the Trump administration to update its testing prioritization guidelines to ensure limited test resources are directed to those with a medically indicated need.  

Dive Insight:

Commercial labs such as LabCorp and Quest have been scrambling to meet growing demand for COVID-19 molecular diagnostic tests and looking for ways to reduce turnaround times for test results. Since late June, both companies have cited constraints in the availability of lab equipment and supplies as major hurdles to ramping up their respective coronavirus testing capacities. 

In the case of Aegis and Sonic, Giroir told reporters Thursday that HHS is "investing where we can" and said the agency "acted aggressively" to help expand test capacity at the two labs. As part of the agency's $6.5 million investment, Thermo Fisher is providing HHS with 56 KingFisher Flex extraction and purification systems and 40 QuantStudio 7 Flex Real-time PCR systems, each of which can run 384 samples at a time.

The 96 Thermo Fisher systems, capable of running more than 140,000 samples per day, will be installed at Aegis facilities in Nashville, Tennessee, and at Sonic labs around the U.S. A Thermo Fisher spokesperson said that some units have already been shipped and others are being scheduled.

"The labs will each receive a bundle of instruments consisting of 4 Kingfisher instruments and 2 QuantStudio 7 with 384 well plates," the spokesperson said, noting that Aegis will receive six bundles and Sonic will receive eight.

HHS provided scant information on the specific equipment that Beckman Coulter will be providing to the labs other than to say it will boost COVID-19 testing by up to 10,000 tests each day at 10 separate sites for a total increase of 100,000 per day nationwide. Beckman Coulter was not available for comment.

Aegis in a written statement said it's aiming to ramp up its PCR test capacity to 60,000 tests per day by the end of September, thanks to the HHS acquisition of Thermo Fisher equipment and supply chain components.

However, on Tuesday, the American Medical Association, the American Society for Clinical Pathology, and the Association for Molecular Pathology were among seven organizations that warned HHS "the country continues to struggle to provide laboratories with a consistent supply of reagents, viral transport media, plastics (such as a pipette tips), and other items."

Giroir insisted on Thursday's call with reporters that "there are supplies out there" and while there are limitations on certain testing materials if labs have "flexibility and workarounds that's the way we solve the problem."

ACLA president Julie Khani applauded HHS actions to provide support and resources to its member companies Aegis and Sonic. “Supply scarcity has periodically forced many labs to operate below capacity," Khani said in a written statement. At the same time, Khani again called for Congress to ensure testing is covered for groups like nursing home employees, food industry workers, teachers and students.

In late July, ACLA was among nearly 50 organizations that sent a letter to congressional leaders requesting dedicated federal funding for COVID-19 testing needed to safely reopen the country.