The new company has been launched to provide laboratory-based drug discovery and clinical trials services to the pharmaceutical and biotech industries. Lab21 services include lead identification and optimisation, resistance profiling, clinical candidate selection and selectivity evaluation in pre-clinical situations.
Once a drug is in the clinic, Lab21 offers pharmacogenetic testing and trial stratification, FDA requirements for registration, efficacy studies and resistance monitoring.
Lab21 is to be supported financially by Merlin Biosciences, with its chairman, Professor Sir Christopher Evans OBE leading the Lab21 board of directors. Its laboratories are to be based in Cambridge, UK, with commercial headquarters located in Fareham, UK.
"We believe that Lab21 has already made progress towards personalised healthcare. Our portfolio allows the characterisation of a virus, the assessment of prospective drug candidates, and the understanding of potential resistance," said Dr Nick Kerton, CEO of Lab21.
"In addition, we can genotype a trials population, assess their pharmacogenetics, or monitor patients undergoing therapy," he added.
With evidence showing that many drugs do not work for every individual in a population of patients, the pharmaceutical industry is moving in two directions.
'Blockbuster' drugs are being sidelined in favour of tailor-made treatments with smaller patient groups in mind. In addition, molecular diagnostics will determine in advance if a patient is likely to respond well to a certain drug, or experience unwanted side effects, or develop resistance.
A spokesman for Lab-21 told DrugResearcher.com: "Lab21 certainly supports the principle of 'personalised medicine'. Avoiding damaging side effects, improving drug safety, and making drug discovery faster and more productive are important characteristics of this approach."
"The FDA are now calling for pharmacogeneitc data in support of new drug applications - and the experience, tests and technology platforms that Lab21 provides can deliver this," he added.
In addition to the FDA's latest move, recent UK government guidelines have called for genetic testing to be used as a front-line test for the diagnosis of Cystic Fibrosis in babies.