MONOGEN RECEIVES FDA APPROVAL FOR PAP TEST
Oxbow Equities has received FDA premarket approval for its MonoGen MonoPrep Pap Test. The MonoPrep Pap Test is intended for use in collecting and preparing cervical-vaginal cytology specimens for Pap stain-based screening for cervical cancer, its precursor lesions, and other cytological.
The MonoPrep Pap Test produces slides that are intended to replace conventionally prepared Pap smear slides. This FDA approval enables MonoGen to begin commercial distribution of the MonoPrep Pap Test in accordance with FDA conditions for medical device distribution within the U.S.
Based in Chicago, MonoGen is a private medical device company developing an integrated suite of automated devices for anatomic and molecular pathology laboratories.