Cyprotex PLC (AIM:CRX), a specialist ADME-Tox and Bioscience Contract Research Organisation, today announces the launch of GLP-compliant genotoxicity services. The new services will be offered from its Kalamazoo laboratories in Michigan in the USA. This site is already GLP-compliant and offers a number of other regulatory tests for determining skin absorption and skin and ocular toxicity as well as endocrine disruption.
Within the facility, a range of new genotoxicity services have been fully validated according to OECD test guidelines. The services include the bacterial reverse mutation test, otherwise known as the Ames test (OECD test guideline 471) and the in vitro micronucleus test (OECD test guideline 487). The in vitro mammalian chromosome aberration test (OECD test guideline 473) will follow shortly after. These methods cover a number of different genotoxic mechanisms, and form a panel of in vitro protocols which are accepted by regulatory authorities.
A number of different industries rely on genotoxicity testing for evaluating potential risk to human health, and it is a regulatory requirement in the pharmaceutical, veterinary, chemical, pesticide and cosmetics and personal care industries. All these industries now incorporate in vitro methods into their testing cascade for genotoxicity assessment. Having robust GLP- compliant methods which follow recommended guidelines is critical for submission of these data to the regulatory authorities.
Anthony Baxter PhD, Chief Executive Officer of Cyprotex, comments on the launch of the new genotoxicity services, ‘Genotoxicity testing is a regulatory requirement within a number of different industries. In vitro genotoxicity methods are now acceptable alternatives, either to completely replace animal testing as is the case with cosmetics products in Europe, or to be used within a testing battery to reduce the use of animals as is the case for pharmaceuticals or pesticide products. By introducing a suite of GLP compliant genotoxicity services, Cyprotex is addressing the needs of these markets for high quality regulatory accepted methods.’
For Further Information
Tel: +44 (0) 1625 505 100
Dr Anthony Baxter, Chief Executive Office
John Dootson, Chief Financial Officer
Mark Warburton, Chief Operating Officer and Legal Counsel
Cyprotex is listed on the AIM market of the London Stock Exchange (CRX). It has sites at Macclesfield and Alderley Park, both of which are near Manchester in the UK, and at Watertown, MA and Kalamazoo, MI in the US. The Company was established in 1999 and works with more than 1300 partners within the pharmaceutical and biotech industry, cosmetics and personal care industry and the chemical industry. Cyprotex acquired Apredica and the assets of Cellumen Inc. in August 2010 and the combined business provides support for a wide range of experimental and computational ADME-Tox and PK services. The acquisition of the assets and business of CeeTox in January 2014 has enabled Cyprotex to expand its range of services to target the personal care, cosmetics and chemical industries. In 2015, Cyprotex launched its new bioscience division to expand its capabilities into phenotypic and target based screening. The Company’s core capabilities include high quality in vitro ADME screening services, mechanistic toxicology and high content toxicology screening services, including our proprietary CellCiphr® toxicity prediction technology, bioscience services, predictive modelling solutions including Cloe® PK, chemPK™ and chemTox, and a range of skin, ocular and endocrine disruption services. For more information, see www.cyprotex.com.