Novacyt Signs Strategic Alliance with Cepheid for HPV Diagnostics in Latin America

Regulatory News:

Novacyt (ALTERNEXT: ALNOV), an international specialist in clinical diagnostics, today announces it has entered into a strategic alliance with Cepheid Inc., a leading international molecular diagnostics company, to introduce a complete Human Papillomavirus (HPV) diagnostic system into Latin America.

There is a clear association between repeated HPV infection and cervical cancer. It is reported that 80% of the cervical cancer cases diagnosed globally are reported in developing countries¹. Latin America has one of the highest incidence and mortality rates from cervical cancer in the world², which is estimated to be 20 to 80 per 100,000 women per year. This strategic alliance will target 18 countries within Latin America.

Under the terms of the three year, non-exclusive agreement, Cepheid and its distributor partners will distribute Novacyt’s NOVAprep^® vial, media and cervical sample collection device to be used alongside Cepheid’s Xpert^® HPV assay (CE-IVD) to test for high risk HPV infection, either as a primary cervical cancer screen test or as a reflex test to cytology. Data published at the HPV 2015 scientific congress in Lisbon, Portugal, demonstrated that Novacyt’s proprietary technology platform, NOVAprep^®, and Cepheid’s Xpert^® HPV test produced highly accurate results in comparison to Roche cobas HPV results from the same specimens. The Novaprep LBC flexible solution combined with the Xpert platform enables a wide range of laboratories to provide a molecular HPV service that meets their workflow needs. Cepheid already has over 11,000 Xpert^® systems installed globally.

Graham Mullis, Group CEO of Novacyt, commented:

"We are delighted to announce this strategic partnership with Cepheid, a global leader in molecular diagnostics. HPV testing is in a multi-billion dollar market³. The combination of NOVAprep^®’s proprietary sample collection and preparation capability together with Cepheid’s diagnostic system positions us well for growth in Latin America. Our unique approach will provide significant benefits to patient risk stratification and we look forward to working with Cepheid in this new market and region for Novacyt.”

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About Novacyt Group

The Novacyt Group is a leader in the field of cellular diagnostics with a growing portfolio of cancer and infectious disease products and services. Through its proprietary technology platform NOVAprep® and molecular platform, genesig® Novacyt is able to provide an extensive range of oncology and infectious disease diagnostic products across an extensive international distributor network. The Group has diversified sales from diagnostic reagents used in oncology, microbiology, haematology and serology markets, and its global customers and partners include major corporates.

For more information please refer to the website: www.novacyt.com

About Cepheid Inc.

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit www.cepheid.com.

¹ http://www.transparencymarketresearch.com/cytology-hpv-testing-market.html

² Cancer Epidemiol Biomarkers Prev. 2012 Sep;21(9):1409-13. doi: 10.1158/1055-9965.EPI-12-0147

³ Grand View Research, Inc.

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