Benefits of proactive engagement
A key conclusion is that laboratories need more time to prepare for the effective introduction of novel tests, with 40 percent
of laboratories indicating that it took between seven to 12 months to fully implement a new test and a further 25 percent
indicating their belief that they could make a new test available in three to six months. These lag times required to prepare
for the introduction of these novel tests are not recognized by the pharmaceutical industry today, which opens up the very
real risk that the demand for a therapy will be held back by the lack of a readily available test to a physician.
Feedback from laboratories also revealed (see Table 1) that there are ten key areas of primary concern when introducing a
new test, all of which required additional investment of time and expense on their part.
Table 1: What are the key areas of concern regarding the introduction of a new test into your laboratory?
An area of concern highlighted by the Delphi survey was the apparent preference by laboratory managers for LDTs versus the
purchase of an IVD kit, as shown in Table 2. The majority of laboratories (48 percent) responded that their decision on which
type of test to use depended upon the frequency of demand (utilization) for the test, with only 23 percent of laboratories
indicating that a first preference would be the purchase of a kit.
Table 2: What is your preference when introducing a new diagnostic?
The simple fact is that the medical laboratory, much more than the diagnostic company, is located at the single most influential
junction point in the supply chain for companion testing within the field of personalized medicine. The laboratory is best
placed to diffuse high quality testing, help educate physicians on biomarker choices, and deliver superior service around
analysis, interpretation, and turnaround time. We conclude that a greater understanding of the current impediments to implementing
companion testing and recognition of the laboratories' future role in evolving personalized medicine as a benefit to patients
is urgently required from Big Pharma development and commercialization teams seeking to launch novel targeted therapies.
Peter Keeling is CEO of the Diaceutics Group, a business software firm specializing in personalized medicine. He can be reached at email@example.com
. Maria Fe Paz is Managing Director of the Labceutics Division of the Diaceutics Group.