Laboratory Corporation of America (NYSE: LH) has received a about its recently launched ovarian cancer screening test.

The test requires FDA approval and has not received such endorsement, the FDA said.

LabCorp spokesperson Eric Lindblom told Reuters that the company is in discussion with the FDA about the matter. He added that LabCorp was “disappointed” by the letter.

The test is sold under the name OvaSure. It went on sale from June. The technology was developed at Yale University.