FDA Watch: Diagnostics Industry Is Losing a Longstanding “Frenemy”

The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the FDA Office of In Vitro Diagnostics (OIVD), announced that he will step down from the agency at the end of September.

Gutierrez the Friend

Gutierrez has been a central figure in moving the FDA forward on precision medicine and next-generation sequencing (NGS) tests. In 2009, he took over the OIVD, which was created to consolidate pre-market and post-market in vitro diagnostics into a single office. Under Gutierrez’s leadership, the agency liberalized its approach to precision medicine and began working with the diagnostics industry to streamline procedures and ease approval of personalized treatments and companion tests identifying patients for those therapies. According to the non-profit Personalized Medicine Coalition, precision treatments accounted for over 20 percent of new molecular entities approved by the FDA in the past three years.

Under Gutierrez’s leadership at OIVD, the agency put out draft guidelines on how labs could demonstrate analytical validity for germline NGS tests and encouraged data sharing by proposing the use of public variant databases to establish clinical validity of NGS tests. More recently, the agency approved the first NGS-based companion diagnostic and the first panel CDx that can identify best responders to multiple lung cancer drugs.

His tenure also coincided with the FDA crack down on direct-to-consumer (DTC) marketing of health-related genetic tests by companies like 23andMe. But while the agency thwarted sale of genetic tests for serious diseases like Alzheimer’s without a prescription, the Gutierrez-run OIVD took a more accepting approach to DTC access of raw genomic data for recreational genomics, such as ancestry testing.

Gutierrez the Enemy

However, while his legacy will be more positive than negative, Gutierrez’s tenure as OIVD director will also be associated with the FDA’s controversial policy to regulate LDTs. Historically, the FDA left such regulation to CMS under CLIA. Believing that LDT marketing was getting out of hand, Gutierrez was one of the architects of the 2014 draft regulatory guidance proposing tight FDA control over LDTs.

Gutierrez’s departure comes at a time when the agency appears to be backing away from heavy-handed regulation of LDTs. After declining to issue a final version of the draft guidance at the end of 2016, the FDA outlined a softer, more collaborative approach in a January discussion paper. However, while it strikes a tone that is more welcoming to the industry with regard to LDTs regulation, the discussion paper does not go as far as dropping the idea altogether. (See “Discussion Paper Signals New Approach to LDTs Regulation, LIR, Jan. 2017). “It’s very much unknown how laboratories are going to be regulated, if at all, on LDTs,” Gutierrez is recently quoted as saying.

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Here’s a look at key FDA diagnostics approvals in late August through September:

New CE Marks & Global Certifications

Here’s a summary of notable European CE certifications:

Here’s a summary of notable European CE certifications:

New international approvals included:

• China Food and Drug Administration registration of Isohelix’s DNA buccal swabs; and with the; and

• Agência Nacional de Vigilância Sanitária (Brazil) B-GMP approval of Premaitha Health’s Iona test.