Enzo Biochem Inc. (NYSE:ENZ), as part of its continuing program to offer novel molecular tests, announced that its Enzo Clinical Labs subsidiary has reached an agreement with IncellDx Inc. of Menlo Park, CA, for the rights to market a proprietary laboratory test. The test is based upon HPV OncoTect™, an advanced molecular diagnostic technology for quantifying specific biomarkers that have been associated with an increased risk of progression to cervical cancer and will further expand Enzo’s approach to providing comprehensive clinical information to physicians for managing diseases associated with women’s health. Upon receiving the appropriate approvals, Enzo will become the first New York licensed reference laboratory to offer the test.
HPV OncoTect™ is a novel method for screening for the likelihood of progression to cervical carcinoma by measuring potential oncogenic activity of the human papillomavirus (HPV) in infected cervical cells. The assay functions by detecting and quantifying the expression of viral oncogenes responsible for triggering progression to cervical cancer, thus improving the specificity that existing tests lack. As with other assays developed at Enzo Clinical Labs, HPV OncoTect™ will be validated during in-house studies prior to seeking New York State approval under a “LDT” regulatory pathway. Favorable reimbursement already exists for this type of testing.
“The HPV OncoTect™ technology is a flow-cytometry based method that can be used to identify the genetic expression of HPV that has already integrated into the cell, offering a better indicator of serious HPV infections than can be accomplished by identifying the presence of the virus alone,” said Dr. Robert Boorstein, MD, PhD., Medical Director of Enzo Clinical Labs. "This addition to our growing line of molecular diagnostic tests for women’s health underscores our expanding specialization in advanced clinical and diagnostic testing. We intend to use this test initially for patients who have been shown to be HPV positive by standard techniques”