Hologic (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing.
Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July, as did LabCorp, in an EUA reauthorization. Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing the testing method in June.
The FDA is touting pooled-sample testing as more efficient than individual tests, meaning fewer testing supplies are used and more tests can be run at the same time, allowing patients to receive their results more quickly in most cases. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative, according to the agency.
Quest’s authorization permits the pooled testing of up to four individual swab specimens from patients suspected of having COVID-19; LabCorp’s EUA allows for five specimens per testing pool, as would Hologic’s. In cases of a positive result, all five samples would be re-tested individually to determine which patient or patients are infected.
“By providing a pooling protocol, we are helping our lab customers meet the extraordinary demand for highly accurate molecular test results during this unprecedented time,” said Kevin Thornal, president of Hologic’s diagnostic solutions division, in a news release. “Pooling will enable more samples to be tested each day, but at the same time, help test results get back to patients and their caregivers faster. I am very proud of the ingenuity and innovations that our Hologic teams continue to bring to fighting this pandemic.”
Hologic is spending $50 million — including $14 million during its most recent quarter — to boost its production of COVID-19 tests. The U.S. government is providing $7.6 million to support the effort.