Labcorp launches monkeypox PCR tests through CDC initiative

With the monkeypox outbreak continuing its steady spread around the globe, diagnostic test makers have taken it upon themselves to develop and roll out tests for the disease as quickly as possible.

Among those testing providers reacting to the outbreak is Labcorp, which was tapped by the U.S. Centers for Disease Control and Prevention last month to help make monkeypox testing widely available through its broad network of diagnostic labs.

Those efforts are now taking effect, as Labcorp announced Wednesday that it will begin testing for the viral disease using the CDC’s orthopoxvirus test, which Labcorp helped validate for the agency. The PCR test is designed to detect all non-smallpox-related orthopoxviruses, a group that includes cowpox, horsepox and camelpox, along with monkeypox.

To start, Labcorp will perform all monkeypox testing at its North Carolina lab—the company’s main lab and its largest in the country—according to Brian Caveney, M.D., the company’s chief medical officer and president of diagnostics. From there, if necessary, the testing could expand to other Labcorp locations across the U.S.

As the initiative ramps up, Labcorp said it could eventually perform up to 10,000 monkeypox tests per week, which would double the CDC’s current capabilities. Those tests will include standard orders from Labcorp’s healthcare provider customers located across the country and, potentially, overflow from public health laboratories.

Labcorp’s launch comes shortly after the CDC began expanding its monkeypox testing capabilities beyond the public health Laboratory Response Network (LRN), to a handful of commercial diagnostics providers. Besides Labcorp, those commercial labs tapped to roll out the orthopoxvirus test include Aegis Science, Mayo Clinic Laboratories, Quest Diagnostics and Sonic Healthcare.

When the CDC announced the expansion at the end of June, it noted that U.S. healthcare providers would be able to begin ordering the test from those labs in early July, and that the labs would continue increasing their testing capacity throughout the month. At that time, the agency had already expanded the LRN’s reach to offer more than 8,000 tests per week through nearly 70 public health labs representing almost every state.

Amid the expansion of the CDC’s orthopoxvirus test, several diagnostics companies are in the process of developing and launching their own monkeypox-specific assays.

BD, Cepheid and Roche have all joined the race to roll out accurate, PCR-quality tests for the disease. BD has joined forces with CerTest to adapt one of the Spanish company’s existing tests to run on the BD Max automated PCR system, while Cepheid partnered with reagent maker BioGX to design a molecular assay of its own.

Roche, meanwhile, beat the crowds by launching a trio of tests for monkeypox in May—with the caveat that scientists around the world can use them for research use only.