Secaucus-based Quest Diagnostics on Thursday said it received U.S. Food & Drug Administration emergency use authorization for its lab-developed test specifically designed to detect monkeypox virus DNA.
The EUA is the first granted to a commercially available monkeypox test in the U.S.
“Quest is committed to developing high-quality diagnostic innovations to help respond to the monkeypox public health emergency,” Dr. Jay Wohlgemuth, senior vice president, research & development, medical, and chief medical officer, Quest Diagnostics, stated. “With this FDA emergency authorization, Quest is positioned to complement the response of public health laboratories and help fight the spread of the virus.”
On Wednesday, the Department of Health and Human Services declared that the public health emergency countermeasures now extend to monkeypox testing.
Quest launched the Quest Monkeypox PCR test nationwide on July 13. The company performs the test at its advanced laboratories in San Juan Capistrano, California, and, beginning last week, Chantilly, Virginia, for ready access for providers and patients on both coasts of the U.S.
New York’s Department of Health has approved the tests from both laboratories, enabling access for patients living in the state.
Developed with the understanding that viruses mutate, the Quest Monkeypox PCR test features the ability to detect two different DNA targets (monkeypox and non-variola orthopoxvirus DNA) to help protect against false negatives.
The Quest Monkeypox PCR test uses swab specimens collected by health care providers, such as in physician offices and hospitals, from patients presenting with an acute generalized pustular or vesicular rash. Quest collects specimens for this test through its nationwide network of physician offices and hospital partners and also enables patients with suspected or confirmed monkeypox infection to visit its locations for phlebotomy blood draws and other non-swab specimen collections required for other types of laboratory testing.
This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories.