Manipal AcuNova's Central Reference Laboratory (CRL) at Bangalore bagged the National Accreditation Board for Testing and Calibration Laboratories (NABL) certification for Molecular Diagnostics tests. The company is also selected by Department of Biotechnology for four out of seven clinical study projects. Although the primary focus of Manipal AcuNova is clinical trails, it has teamed up with Nordiag, a cancer diagnostics company only to build its competency around the biomarkers.

The CRL specializes in patient testing, advanced molecular diagnostics and clinical trial testing. The accreditation is a growth strategy where the company will not only be able to increase its patient pool and revenues but augment business repeatability, which is a true test to a CRO capability. Its global projects to national projects ratio are pegged at 70:30. The NABL is for medical diagnostic testing and is expected to give the much-needed boost to its clinical research activities in the regulated marketed like Europe where companies are scouting for outsourcing projects from certified and reliable CROs in India.

Although the NABL accreditation is a formal recognition of technical competence, it is based on third party assessment. WTO recognizes non-acceptance of test results and measurement data as Technical Barrier to Trade (TBT). NABL is now on par with APLAC (Asia Pacific Laboratory Accreditation Cooperation), MRA (Mutual Recognition Arrangement) partner and signatory to ILAC (International Laboratory Accreditation Cooperation) arrangement based on peer evaluation by a multi-disciplinary team from APLAC.

The company is already acknowledged as the first Indian CRO to be ISO 9001 certified for managerial requirements and accredited by Department of Science and Technology, Government of India. It is also approved for Information Security (ISO27001:2005) compliance by Underwriters Laboratory. All these achievements would provide the biotech, pharma and diagnostic majors the assurance for high quality global studies on time.

"While pilot studies need only NABL compliance, pivotal studies require a certification. NABL is mandatory for trials as the clinical consistency in the results would be comparable to global labs. We can now enhance our competitive advantage in the global arena and participate in global trials like WHO and Gates Foundation studies on orphan drugs, DA Prasanna, vice chairman and managing director, Manipal AcuNova told Pharmabiz. "We will also gear up for repeatability in business and later move on to acquiring companies to strengthen our domain expertise," he added.

The company value chain covers clinical research, which includes data management, central lab and core imaging services.

CRL has 100 customer case centres and a dedicated sales team. Its patient testing service offers advanced molecular and esoteric diagnostic services. The clinical trial and pharma company research services provide tailored studies using molecular and cellular sciences. The focus is oncology, HIV/AIDS, infectious diseases, endocrinology (diabetes), nephrology, psychiatry, cardiology, neurology and CNS (central nervous systems), a new addition.

"The business of clinical research is frustrating in the sense that the whole process is long drawn with several quality parameters being assessed. Now we can reinstate our quality and speed to deliver capabilities to global customers," informed Prasanna.