Companion Diagnostics Support for Market Entry

 

Lab21 Companion Diagnostics Services facilitate drug market entry

Lab21 is the leading provider of Companion Diagnostics services in the UK, Ireland and the Middle East, with a rapidly growing test portfolio and a global customer base. We have a proven track record in facilitation of market entry for targeted therapies in Oncology and HIV.

Lab21 provides a comprehensive, accredited service according to partner requirements including dedicated customer services, rapid turnaround times, sample logistics and electronic reporting of results. Our laboratory accreditations and registrations include ISO 9001, CPA (ISO 15189), CLIA and GCLP.

Cetuximab, Panitumumab and KRAS mutation testing

We played a crucial part in the launch of the colorectal cancer drugs Cetuximab (Erbitux®, Merck Serono) and Panitumumab (Vectibix®, Amgen) in the UK, Ireland and the Middle East by providing rapid, reliable and regulatory approved KRAS mutation testing services to the clinicians. Lab21 continues to be the major UK clinical laboratory for KRAS mutation testing, used by clinicians in both public and private sectors.

Gefitinib, Erlotinib and EGFR mutation testing

Lab21 was the major commercial laboratory trusted by AstraZeneca and Roche to aid the launch of the NSCLC drug Gefitinib (Iressa®, AstraZeneca) in the UK, Ireland and the Middle East by the provision of EGFR mutation testing services to clinicians. Lab21 is also the only commercial laboratory to perform EGFR mutation testing for Erlotinib (Tarceva®, Roche) for the Irish market. As opposed to Gefitinib, EGFR mutation testing was not required at launch, but has subsequently been shown to improve patient outcome. Again, Lab21 continues to be a major UK clinical laboratory for EGFR mutation testing for both the public and private sectors.

Maraviroc and HIV-1 tropism testing

Maraviroc (Celsentri®, Pfizer) is an HIV drug that acts as CCR5 receptor antagonist and requires determination of the patient’s HIV tropism before use. Lab21 has supported Pfizer and then ViiV Healthcare by providing Companion Diagnostic testing for this drug, first by partnering with Monogram, US for Trofile® testing, and subsequently by developing and providing its own HIV-1 Tropism by Genotype testing service for clinicians.

The Lab21 Companion Diagnostics portfolio is growing rapidly, and we have also developed and provide a wide range of pharmacogenetics, drug resistance and therapeutic drug monitoring services for healthcare providers to aid the safe and effective use of oncology and viral therapeutics.

Companion Diagnostics Products

The availability of regulatory approved assays is essential for the provision of standardised, safe and reproducible Companion Diagnostics services across different clinical laboratories in different countries. Lab21 provides full assay development, clinical trial, manufacture, regulatory approval and commercialisation services for such assays.