IncellDx® Receives North American Product Leadership Award in the Molecular Diagnostics Market From Frost & Sullivan

OncoTect® Test for Cervical Cancer Described as the “Gold Standard for Gynecological Care”

IncellDx® Receives North American Product Leadership Award in the Molecular Diagnostics Market From Frost & Sullivan

<0> For IncellDxSeth Klukoff, 609-396-0067 </0>

Frost & Sullivan (F&S), an international management consultancy that identifies best practices in research, will present IncellDx with a Leadership Award in the Molecular Diagnostics Market. F&S cited IncellDx’s newly launched cervical cancer testing methodology, , as the company’s “greatest contribution” and the “gold standard for gynecological care.”

Virtually all cases of cervical cancer are caused by specific types of human papillomavirus (HPV). Current testing methods, while reliable in detecting the presence of HPV infection, are unreliable in terms of predicting the likelihood of a patient developing cervical cancer. , however, detects the presence of cell changes due to persistent HPV infection, enabling physicians to distinguish between benign infection and precancerous disease – thereby eliminating the many instances of “false positives” resulting from other test methods. As a result, a woman’s increased risk for future development of cervical cancer can be determined with remarkable accuracy and unnecessary invasive procedures can be avoided.

According to F&S, “will ultimately revolutionize cervical cancer testing given its improved accuracy, greater efficiency, and lower cost when compared to traditional methods.” F&S believes that clinicians will see great value in , since the test improves the specificity of high-risk HPV screening. “Additionally, many of the world’s largest laboratories are eager to adopt since it provides them with a competitive advantage over laboratories that just offer HPV genotyping.”

was the focus of two independent clinical studies in Greece and Italy, yielding superior results against other commercially available tests. In both studies, which analyzed cervical cell samples, researchers found that was able to more accurately determine which cells were pre-cancerous.

In May 2011, IncellDx launched the next generation of the test – called . By providing both molecular and morphological data about a sample, allows laboratories to completely digitize the cytopathology process, making the microscope unnecessary for cervical cancer screening. Given that analyzing Pap slides can be a laborious and inefficient process, F&S expects to “transform the cytopathology laboratory,” and become “the primary approach to testing.”

“We are thrilled that Frost & Sullivan recognizes us as a leader in molecular diagnostics, and acknowledges our groundbreaking work in the field of women’s health,” said Bruce Patterson, CEO and Co-Founder of IncellDx. “ and are important breakthroughs, because both of these tests differentiate cervical cancer from pre-cancer, eliminating uncertainty in the screening process and leading to a much more accurate diagnosis. We look forward to building on our efforts and to develop new ‘best practice’ tests in other critical clinical areas.”

In the United States, GenPath, a business unit of BioReference Laboratories, has licensed the OncoTect technology and offers GenCerv as a clinically validated test.

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