With the move toward more personalized medicine plans outside of just oncology, biopharma companies are developing more companion diagnostic (CDx) tests to give patients access to new therapies. While historically partnering with in vitro diagnostic (IVD) companies has proven successful in the path of development, regulatory filing and commercialization, IVD companies have small sales forces and are ill-equipped to handle the large commercialization challenges that these CDx tests bring.
As a result, patients in need of these tests may fall through the cracks, causing patient leakage (in which potentially eligible patients fail to be tested), for a variety of reasons. To counter this, L.E.K. recommends that biopharma companies partner with large reference laboratories to commercialize CDx tests. Warning that patient leakage will intensify with the growing need for CDx tests, biopharma companies can benefit from the increased capabilities and output that reference labs offer, while not overtaxing smaller IVD companies.