A couple years ago, a friend who works in venture capital asked me, "What are the main hurdles to success for a startup molecular lab?" This topic is timely given the new burst of enthusiasm and venture funding flowing into LDT and usually Next Gen molecular diagnostics in 2H2015 and early 2016. Liquid biopsy oncogene panel tests are rising rapidly in prominence and fall into the LDT category for the foreseeable future.
One of the easiest entry points to the topic was writing a white paper on some of the key barriers that are poorly understood outside the field, such as the challenges of a new lab being "out of network" with the health plans of the patients it provides tests for. This and other distinct business challenges are explained in my white paper, "Evolving Challenges for Value Priced LDTs."
While the body of the white paper remains as written in 2014, the topics are timely. For example, out of network labs were covered in Dark Daily in December 2015 (here). However, 2015 topics like PAMA are not covered in this white paper.
The white paper is archived in the cloud and can be downloaded, here.