By Kirell Lakhman

The Association for Molecular Pathology has told FDA that a recently released draft guidance could "compromise the quality of patient care" by "severely reducing" clinical labs' access to many "standard of care" reagents and lab-developed tests.

If approved in its current form, the draft, issued June 1 and entitled "Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions," would require test makers to seek FDA clearance for some RUO products that are currently used in many lab-developed tests.

AMP warns this could reduce the availability of testing services, limit healthcare providers' ability to manage their patients, and hamper clinical labs' ability to do their job.

Too right. If reagents or other test components have been used for years safely and efficaciously, why change the rules mid-play and risk blunting test makers and clinical labs, not to mention patient safety, which is FDA's chief mandate?

In the case of test makers marketing RUO-labeled IVDs, because the draft would seek clearance from products already used in clinical labs, it could end up discouraging test makers from considering submitting their products to CDRH.

This unintended consequence — a phenomenon closely associated with FDA these days — becomes even more likely for products that generate low test volume, which by definition yield lower revenue.

"While AMP appreciates the FDA concern over the use of RUO … products in laboratory developed tests, [AMP] questions the underlying assumption that the guidance will encourage most manufacturers to seek clearance and approval" for these products, said Elaine Lyon, chair of AMP's Professional Relations committee.

Indeed, if enforced in its "broadest sense without sufficient accommodations for low test volume or sufficient time for manufacturers to achieve submission compliance," the draft could "ultimately limit patient access to new or improved molecular tests," said Lyon.

To be sure, we're not just talking about novel, esoteric assays. "If this guidance were to be finalized, we're concerned that patients won't be able to access tests such as those for hepatitis C genotyping, newborn screening, and HLA testing," Lyon cautioned.

According to AMP, "this has already occurred for many analytes, from blood-borne pathogens to sexually transmitted diseases," and "would … [go on to] create a shortage of supplies to develop laboratory tests, resulting in a scarcity of tests."

But there is another option, one that would leave unhurt FDA's regulatory credibility and keep intact the essence of its RUO/IVD guidance.

According to Lyon, AMP has asked the agency "to consider the downstream implications of the guidance on the supplies and materials for laboratory testing, and allow for circumstances where clinical laboratories can develop tests using RUO … products when no other products are available."

The recommendations include "carefully considering" enforcement discretion or alternative regulatory pathways "to address circumstances where no FDA cleared/approved products are available, particularly for those products with limited sales volume."

This wouldn't be too much of a leap for the agency. It's shown very recently how flexible it can be with enforcement discretion.

Another option is for FDA to "direct enforcement requirements for 510(k) or PMA submissions toward test kits and test systems," and to create a "consistent and clear pathway to encourage and facilitate" ASR, 510(k), or PMA applications for RUO products — and with a reasonable compliance timeline. And of course, the pathway "must include flexibility to be responsive to rapidly evolving areas."

For this FDA will have to get creative. Despite its power and influence, it isn't the fastest draw when it comes to its prescience for, or reaction to, new technologies.

In addition, AMP suggests the agency make "accommodations … to enable certain reagents such as primer or probe mixes to be sold as ASRs." Either that or design a new regulatory pathway for products that are "too complex to qualify as ASRs but are not full test kits or test systems."

Lastly, AMP says FDA should "clearly state the scope of the guidance," which should clarify which RUO-labeled products — instruments, software, reagents — the guidance will cover.

Let's not let our LDTs and IVDs become MIAs.

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