Regulated and Disseminated: A Way Forward For LDTs | Diaceutics

Regulated and Disseminated: A Way Forward For LDTs

November 18th, 2012

Ron Mazumder PhD

Ron Mazumder of Janssen Diagnostics discusses how laboratory developed tests offer pharma an opportunity and comments on how risk can be minimized and how they could be used alongside in vitro diagnostics.

Laboratory developed tests (LDTs) have proliferated throughout the diagnostics industry and the centralized reference lab has become a significant channel through which certain content can be delivered. Because these LDTs have not historically been subject to the same regulations as in vitro diagnostic tests submitted to the FDA, many LDTs may not have undergone rigorous analytical and clinical validation, potentially leading to precision and accuracy issues. Indeed, a recent external quality assessment has shown that, among 59 laboratories in Europe which used their own preferred method for DNA isolation and mutation analysis, only 69 per cent of laboratories correctly identified KRAS mutational status in all ten samples used in the assessment1. This situation has led to the 2008 filing of a citizen petition by Genentech to the FDA considering implementation of a risk-based oversight of LDTs3, and numerous comments by diagnostics manufacturers on the companion diagnostics draft guidance issued in 2011.

If the playing field were leveled and LDTs were submitted to the FDA through the pre-market approval (PMA) process (or whatever classification is appropriate, given the risk), there could be several advantages for pharmaceutical developers. First, because the design verification and manufacturing validation timelines are typically shorter for a LDT relative to what is required for a disseminated kit, predictive biomarkers identified late in therapeutic clinical development could still be implemented as an Investigational Use Only (IUO) device at the start of Phase 3. Second, the LDT PMA could eventually be incorporated into a disseminated kit format (i.e., tech transfer), offering a larger commercial channel at drug launch.

How could such forces alter the diagnostics landscape? Some large diagnostics companies may embrace multi-faceted approaches (LDT and kit) to deliver diagnostic information. The flexibility offered by such approaches would not be lost on pharmaceutical developers requiring a companion diagnostic.

References 

1The Oncologist, 2011,16:467

2http://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/PastMeetingsWithFDAOfficials/2009PublicCalendars/ucm183053.htm

3https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm

 

About the Author 

Ron Mazumder obtained his B.A. from The Johns Hopkins University, his PhD from the University of Maryland and his MBA from Lehigh University. He worked for Gen-Probe, Axys Pharmaceuticals and Motorola, developing genomics technologies. Ron joined Johnson & Johnson (Veridex) in 2003 and led feasibility research for molecular diagnostics programs and managed technology and biomarker partnerships. In 2008, he joined Merck as a Senior Director and Biomarker Leader in external discovery, where he was responsible for the development and execution of (pharmacodynamic and predictive) biomarker plans in support of lead optimization and clinical candidates, and also managed external collaborations and technology evaluations. Ron rejoined Johnson & Johnson in 2010 and is currently Global Head of Research and Product Development for Janssen Diagnostics in the Janssen pharmaceutical companies of Johnson and Johnson. He is accountable for all aspects of the development of companion and complementary diagnostics needed to support the therapeutic pipeline, including selection of platforms and partners, oversight of diagnostic development, support of IDE, pre-IDE, PMA and 510k submissions and design of clinical trials for validation of predictive biomarkers. He is also engaged in the development of novel platforms and capabilities.

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