CerMark Cervical Cancer Screen at the Point-of-Care

Gynecologic cancers remain an area of huge unmet need.  The OncoGenesis biomarker-based cancer assays address this unmet need by providing reliable information that enables the gynecologic physician to identify patients with abnormal lesions that need to be treated before the disease progresses into cancer.  Cancer is a complex and multifaceted disease that is caused by multiple genetic and biochemical abnormalities at a cellular level.  Thus, the only method to fully characterize the cellular changes required for carcinogenesis, and to define the state of the disease, is to evaluate multiple biomarkers that reflect critical molecular changes associated with cancerous cells.  The OncoGenesis paradigm is to quantify a novel panel of biomarkers that are proven to be important in characterizing cervical cancers, and to quantify these biomarkers in relatively non-invasive cervical cytology.  These novel biomarkers are embedded in our CerMark cervical cancer screen.

Comparison of CerMark Cervical Cancer screen vs. traditional Pap smear


System comprised of six DISCREET BIOMARKERS

  • HIGHLY SENSITIVE (90% VS 68%) AND SPECIFIC (>90% VS 75%) as compared to Pap smear or LBC Pap test
  • Enhanced accuracy means reduced “missed positives” of CIN 2+ cervical lesions, leading to earlier and less costly treatment of these pre-cancerous lesions
  • Determines the PRESENCE OF HPV infection with EVERY test
  • Biomarkers detect all cellular changes leading to cancer progression / not just the presence of HPV, but those induced following HPV integration
  • Applications for both Central Lab and Point-of-Care applications
  • For the point-of-Care, CerMark-PT utilizes OncoGenesis’ proprietary Genesis POC  instrument
  • With Genesis, enables developing countries to implement cervical screening programs at much lower cost (no lab or cytologists required)cartridge iiii


Pending FDA clearance in the U.S.