This is the second in a multi-part series of posts exploring how the FDA's plan to regulate lab-developed tests may affect clinical labs, the FDA itself, and other major stakeholders. This installment investigates the clinical lab perspective. Part I focused on OIVD.
By Kirell Lakhman
"I just don't know how we're going to pay for it."
Sounds familiar enough: It could be a quote from an article about upside-down mortgages or the ongoing credit squeeze suffocating the national economy.
Alas, it's not. It is a comment made to me last week by the manager of a clinical lab in a small hospital in upstate New York. The manager asked not to be named because she doesn't know her hospital's position on the issue.
"I understand FDA's desire for uniform safety standards, and for a better way to minimize risks from diagnostic tests," she said as she ran CBC, ESR, and MRSA assays on samples from a 9-year-old girl admitted three nights earlier with a 103-degree temperature. "But shouldn't FDA balance that desire with an equally significant risk: the risk of limiting a lab's test menu or hurting innovation?"
Announced in mid-June, the FDA's plan to replace its longstanding "enforcement discretion" policy for overseeing LDTs with a "risk-based” approach would encompass the entire homebrew family tree: high-complexity assays, including tests that would have been called IVDMIAs; genetic and other esoteric tests; and consumer genetic tests, among others.
What FDA terms "risk-based" refers to the kind of calculus it will employ to determine whether relatively simple, low-risk homebrews (such as Pap smears and FOBTs) can retain their original LDT designation, and which higher-risk assays (think HER-2/neu or hep C viral-load testing) would require labs to undergo FDA's lengthy and expensive PMA or 510(k) submission process.
Today, clinical labs shell out between $100,000 and $300,000 to successfully market tests in the latter category, and most estimates show that around 40 percent of all existing LDTs are gene-based or are otherwise esoteric. So a typical lab manager's anxiousness should not be surprising, especially if her facility regularly performs genetic tests.
In addition, when FDA announced its LDT conversion plan in mid-June, clinical labs were facing new cuts in Medicare reimbursement, massive personnel shortages, and a costly panoply of obligatory and recommended private, state, and federal accreditation standards designed to keep them competent and competitive.
FDA has shown it at least knows about these risks. During the upcoming meeting, for example, Tuesday's first panel discussion is called Oversight of LDTs: Clinical Laboratory Challenges. The meeting agenda can be found here.