Home 5 Clinical Diagnostics Insider 5 Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory

By Danielle Sloane bio and Elaine Naughton bio Despite it being a continual topic of discussion, the Food and Drug Administration ("FDA") enforcement in the realm of laboratory developed tests… . . . read more

By Danielle Sloane bio and Elaine Naughton bio

Despite it being a continual topic of discussion, the Food and Drug Administration (“FDA”) enforcement in the realm of laboratory developed tests (“LDTs”) has been relatively quiet in recent years.1 That is, until last week.  On April 4, 2019, the FDA issued a warning letter to Inova Genomics Laboratory (“Inova”) for “illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.” This warning letter should serve as a reminder to the laboratory industry that the FDA can and will take action against LDTs, particularly ones being marketed directly to consumers; and that, if the physician who ordered the test is affiliated with the laboratory, the physician order may not be sufficient to extricate an LDT from being considered “direct-to-consumer” in the eyes of the FDA.2

The warning letter is aimed at Inova’s MediMap tests, genetic tests marketed for predicting medication response, reducing negative side effects from certain medications, discovering the right drug and the right dose for a patient, and avoiding trial-and-error prescribing by testing patient receptivity to drugs.  The warning letter highlighted MediMap Plus—a test designed to provide insights into how a patient might respond to a variety of drugs including those used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes—and MediMap Baby—a test to analyze a newborn’s genes that influence response to 24 medications. According to the FDA, Inova’s website claimed the tests provide “actionable and informational guidance” and that “[h]ealthcare providers can use these results confidently in making treatment decisions.”3 Many of the drugs for which the tests produce results include antidepressants or opioids, which can pose serious health risks if the improper dose is given or if the patient ceases taking the medication altogether.


In its press release, the FDA commented that it “is unaware of any data establishing that Inova’s test can help patients or health care providers make appropriate treatment decisions for the listed drug.”4 The FDA stated that this warning letter “reflects the agency’s commitment to monitor the pharmacogenetics test landscape and take action when appropriate to address a significant public health risk.”5 The Director of the FDA’s Center for Devices and Radiological Health explained that the FDA is “particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions.”

The warning letter highlights that, according to Inova’s website, the “MediMap tests may be ordered by a lab physician in which case test results are provided directly to patients,” which “could lead to patients inappropriately increasing, decreasing, or stopping their medication without their physician’s involvement. . . .” We have explored the FDA’s skepticism of laboratory relationships and affiliations with the ordering practitioner before. See Marketing of laboratory tests to consumers: Is a practitioner order enough to avoid FDA enforcement?. As such, it is not only a physician order, but the independence of the physician behind the order, that may make the difference between LDT enforcement discretion and DTC enforcement action.

The letter gave Inova 15 days to respond to the FDA with the steps it has taken to correct the noted violations.  In an email, Inova stated that it has promptly responded, it takes seriously the FDA’s concerns and is assessing the appropriate path forward to address them.6

This serves as a good reminder that LDTs are still subject to FDCA requirements and FDA enforcement. Given the FDA’s response here, it is likely the FDA will continue to closely scrutinize LDTs and take action where it feels significant public health concerns exist. Each laboratory may want to evaluate whether the physician orders it is relying upon are sufficiently independent to avoid their testing being characterized as DTC. Moreover, laboratories relying on LDT enforcement discretion should carefully evaluate their marketing materials and be prepared to support their claims with clinical data; or, alternatively, consider undergoing the premarket approval or 510k process.

1 Danielle Sloane and Courtney Ginn, Lab Compliance Advisor. Marketing of laboratory tests to consumers: Is a practitioner order enough to avoid FDA enforcement? (March 21, 2016)

2 FDA Warning Letter, Inova Genomics Laboratory (April 4, 2019) available at https://www.fda.gov/ICECI/ EnforcementActions/WarningLetters/ucm634988.htm; FDA News Release: FDA issues warning letter to genomics lab for illegally marketing genetic test that claims to predict patients’ responses to specific medications (April 4, 2019) available at: https://www.fda.gov/NewsEvents/Newsroom/PressAnnounce ments/ucm635283.htm.

3 Id.

4 Id.

5 Id.

6 Scott Taylor, Why the FDA sent a warning letter to this Virginia-based laboratory? WJLA available at https://wjla.com/features/7-on-your-side/fda-warning-letter-to-virginia-laboratory.

About the authors:
Danielle Sloane, of Bass, Berry & Sims, helps national life science and healthcare clients navigate the complex maze of federal and state healthcare laws and regulations. With an analytical eye, Danielle helps her clients mitigate legal risk and achieve regulatory compliance consistent with their business goals. Danielle’s practice involves fraud and abuse, compliance, regulatory and operational matters, transaction structuring and diligence and government investigations. Danielle advises clients on how they can best innovate, evolve and improve patient care within the confines of current healthcare regulatory laws. Danielle was recognized by Law360 as a Rising Star in healthcare in 2017.

Elaine Naughton provides healthcare regulatory counsel as it relates to compliance, operational and transactional matters. Prior to joining Bass, Berry & Sims, Elaine served as a law clerk to the Honorable David J. Hale of the U.S. District Court for the Western District of Kentucky.

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