DiaCarta Inc. Receives CE Mark for QuantiVirus® HPV E6/E7 mRNA Assay

DiaCarta Inc., an in vitro diagnostic company for infectious diseases, cancer and other indications, today announced it has received CE Mark approval for its QuantiVirus® HPV E6/E7 bDNA test, a highly sensitive and specific test for the detection of 14 high-risk types of the human papilloma virus (HPV) for cervical and head and neck cancer screening.

  • Share on TwitterShare on FacebookShare on Google+Share on LinkedInEmail a friend

Hayward, CA (PRWEB) March 15, 2013

DiaCarta Inc., an in vitro diagnostic company for infectious diseases, cancer and other indications, today announced it has received CE Mark approval for its QuantiVirus® HPV E6/E7 bDNA test, a highly sensitive and specific test for the detection of 14 high-risk types of the human papilloma virus (HPV) for cervical and head and neck cancer screening.

The QuantiVirus® HPV E6/E7 bDNA test assays the mRNA expression of the viral E6 and E7 oncogenes providing a more accurate correlation of HPV infection and the potential development of cancer.

“We are very encouraged with our sales launch in China of the QuantiVirus® HPV E6/E7 test for cervical cancer screening through our China affiliate, Kodia Biotechnology Inc. and look forward to providing the QuantiVirus® HPV test in other territories as well as expanding its clinical application for head and neck cancer screening” said Dr. Aiguo Zhang, founder and CEO of DiaCarta. “Our bDNA based E6/E7 mRNA test is the most reliable tool to detect high risk HPVs directly from Pap smear for women cervical cancer screening or directly from saliva for head and neck cancer test without RNA purification and RT-PCR.”

About Human Papillomavirus (HPV)
Genital human papillomavirus (also called HPV) is the most common sexually transmitted infection (STI). There are more than 40 HPV types that can infect the genital areas of males and females of which 14 types are most commonly associated with cervical cancer. These HPV types can also infect the mouth and throat where HPV plays a direct role in head and neck cancer. Most people who become infected with HPV do not know they have it so it is recommended that woman between ages 21 and 65 have regular Pap smears, which examines cervical cells for the presence of irregular and potentially pre-malignant or malignant cells, as well as testing directly for the presence of HPV. With regular Pap and HPV screening and follow-up, cervical cancer is one of the most preventable female cancers.

About DiaCarta Inc.
DiaCarta, based in Hayward, Calif., is developing and commercializing in vitro diagnostics for a wide range of diseases based on branched DNA (bDNA) Signal Amplification technology (Siemens, Germany) and CytoPlexTM, a proprietary multiplex technology platform. This combination of detection technology provides DiaCarta with broad capabilities to detect nucleic acid (DNA, mRNA, miRNA) and proteins for diagnostic applications. In addition, DiaCarta offers a suit of biomarker validation and companion diagnostic development services including a cytokine panel for drug-induced cytotoxicity screening, gene expression measurement services based on bDNA and companion diagnostic development based on our bDNA and multiplexing technology platforms.

About Kodia Biotechnology Inc.
Kodia Biotechnology Inc. was formed in 2009, which is an affiliate of DiaCarta in China. Kodia is focusing on sFDA application process and commercialization of DiaCarta’s products in the region. Kodia was awarded with innovative high technology company from local government and has built 1200 square feet of GMP facility for molecular Diagnostic products. The facility has been ISO13485 certified.

For more information, please contact:
James Erickson
Chief Operating Officer
jerickson(at)diacarta(dot)com
510-314-8858


Contact

  • James Erickson
    jerickson@diacarta.com
    510-314-8858
    Email