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Dx Focus: Trovagene's HPV-HR Assay; BioTheranostics' CancerType ID


Trovagene this week announced the commercial availability of its urine-based HPV-HR (high-risk) assay, a molecular human papillomavirus test.

The test is designed to accurately identify the presence or absence of 15 known high-risk HPV strains, and has a published sensitivity of 93 percent and specificity of 96 percent.

Existing HPV tests are based on analyzing DNA or RNA isolated from cervical cells collected by a trained professional during an office visit. Trovagene has identified and patented specific sequences in the HPV E1 region that allow a single PCR reaction to discriminate between high-risk types and low-risk types using a simple urine sample, according to the company's website. High-risk types generate a size-specific amplicon, while low-risk types do not.

Trovagene said that the non-invasive nature of its test may improve the adoption and acceptance rate of HPV testing.

BioTheranostics said this week that a recently published study demonstrated that its CancerType ID molecular cancer classifier has superior accuracy compared with immunohistochemistry in identifying the primary site in difficult-to-diagnose metastatic tumors.

The comparative effectiveness study, published this month in the Journal of Molecular Diagnostics, is the first comprehensive investigation to directly compare the diagnostic accuracy of the two tumor classification techniques, BioTheranostics said.

In the blinded study, conducted in collaboration with the City of Hope National Medical Center, the authors selected high-grade, primarily metastatic tumors considered diagnostically challenging, and compared the performance of CancerType ID with IHC analysis for diagnosis of tumor type in 122 cases. Results were scored using reference diagnoses established by detailed clinical correlation.

CancerType ID, a 92-gene RT-PCR assay, demonstrated a statistically significant improvement of 10 percent in overall accuracy compared with IHC. Performance differences favoring CancerType ID were more than 20 percent when greater than nine IHC stains were used, likely due to the poorly differentiated nature of the cancers, the authors surmised.

These findings, BioTheranostics said, highlight CancerType ID's clinical utility when an initial IHC panel does not lead to a definitive diagnosis, and when tumor specimen is limited and expanded IHC testing is likely to exhaust tissue that may be needed for predictive biomarker testing.