RE: Reimbursement is critical - RENX vs AGL is a start contrast12 Jun 2022 14:15
The question then becomes should AGL have started offering a LDT when they applied for FDA as a strategic decision to start the process of getting reimbursement codes. However, I don't think you can offer a LDT without a certified lab etc ...............
It does feel like AGL have had a primary focus on FDA which was a key milestone, but in reality, was not stopping the sale/ marketing of the test.
Also will AGL be launching a dedicated website for private payers to order the test and get results ??? I can imagine that there would be some off label use ie private payers not just with MBC sending in blood samples. The cassette would be be optimised for MBC, but I think would still catch other CTC's !!
I think the private payer market could quite quickly ramp up with the right marketing.