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 After declining to issue a final version of the draft guidance at the end of 2016, the FDA outlined a softer, more collaborative approach in a January discussion paper.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.


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

Manufacturer(s) Product(s)
CDC Approval of:
*Human Influenza Virus Real-Time RT-PCR Diagnostic Panel;
*Influenza A/B Typing Kit; Influenza A Subtyping Kit (ver 2);
*Influenza B Lineage Genotyping Kit; and
*Influenza A/H5 Subtyping Kit (ver 3)
Agilent Approval of GenetiSure Dx Postnatal Assay
Abbott Labs Approval of i-STAT Hematocrit test for use on firm’s i-STAT Alinity platform
Immco Diagnostics Approval of ImmuLisa Enhanced Anti-Mitochondria IgG Antibody ELISA to aid in diagnosing primary biliary cirrhosis in conjunction with other lab tests
Viramed Biotech Approval of Borrelia B31 ViraChip IgM Test Kit for detecting IgM antibodies
Biocartis Approval of Idylla Respiratory Panel (IFV-RSV)
Ortho Clinical Diagnostics Approval of Vitros Immunodiagnostic Proeducts Anti-HBe Assay for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection
Ortho Clinical Diagnostics Approval of Vitros Immunodiagnostic Products HbeAg Assay for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection
Ortho Clinical Diagnostics Approval to market itsSera blood-grouping reagents with its ID-Micro Typing System gel card technology for extended phenotype testing

New CE Marks & Global Certifications

Here’s a summary of notable European CE certifications:

Manufacturer(s) Product(s)
Mologic Approval of BVPro, point-of-care rapid bacterial vaginosis diagnostic test
Tetracore Approval of T-Cor 8 portable real-time PCR thermocycler diagnostic system
Shuwen Biotech Approval of real-time PCR-based EGFR detection kit for lung cancer
Sciex Approval of Topaz clinical LC-MS/MS system
IntegraGen Approval of miRpredX 31-3p, test kit for predicting patient response to anti-EGFR therapy
PlexBio Approval of PlexBio 100, second-generation fluorescence analyzer
iCubate Approval of iC-System platform for rapid diagnosis of pathogenic bacteria associated with bloodstream infection
iCubate Approval of iC-GPC assay
Vela Diagnostics Approval of NGS-based Sentosa SQ HIV genotyping assay

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.

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