Enzo Biochem Reports Validation of Three High Quality, Low Cost Biomarkers for Detecting Cancers and Their Progression, Especially in Women’s Health Area

The validated tests complement Enzo’s POLYVIEW® immunohistochemistry (“IHC”) and in situ hybridization (“ISH”) detection platform, an enhanced diagnostic detection system used by pathologists in reading tissue biopsies and favorably cited by a leading peer review publication for showing no false positives.

The new biomarker tests are used in patient tissue samples with elevated levels of three proteins: p16, which aids in the prognosis of cervical cancer; K1-67, an important marker of cell proliferation in different tumors, including cervical and endometrial; and p53, instrumental in diagnosis of high grade gastric, colonic, bladder, endometrial adenocarcinoma and serious ovarian carcinomas.

In the case of the cellular protein p16, its overproduction is closely correlated with Human papillomavirus (HPV) infections of cells currently infecting 9 million Americans. HPV infections have been linked to 90% of cervical and anal cancers, and 70% of vaginal, vulvar and oropharyngeal (throat) cancers. Cervical cancer alone accounts for 250,000 deaths per year worldwide, with the highest incidence in the developing world and the underserved population in the U.S.

The global cancer biomarkers market is projected to reach more than $20 billion by 2022, up from $11.5 billion in 2017 with the global IHC market projected to reach over $2 billion by 2021. Primary biomarkers, including p16, K1-67 and p53 account for a significant portion of the IHC market. Recent increases in the cost of testing p16, K1-67, and p53 continue to negatively affect clinical laboratory profit margins, especially when considering the overall decrease in reimbursement. Enzo’s newly validated tests offer a cost effect solution to this problem.

“As has been demonstrated by the study involving our POLYVIEW® technology, high quality IHC reagents reduce false positive results without compromising signal strength, and the validation of our three biomarkers in combination with this platform offers reliable high throughput staining capabilities with significant cost savings,” said Elazar Rabbani, Chairman and CEO of Enzo. “Pairing the p16 biomarker test, as well as the others, with our POLYVIEW® IHC detection platform, now adapted to an automated workflow, is another vital example of what Enzo is bringing to healthcare in savings and efficiency with our disruptive technology as reimbursement costs continue to shrink diagnostic lab margins.”

About Enzo Biochem

Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and intellectual property through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and deploy products, systems and services that meet the ever-changing and rapidly growing needs of health care today and into the future. Underpinning Enzo Biochem’s products and technologies is a broad and deep intellectual property portfolio, with patent coverage across a number of key enabling technologies.

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