FDA Sets Sights on Laboratory Developed Tests

zintro_labAccording to leading experts, there are over 3,000 Laboratory Developed Tests (LDTs) marketed in the US. LDTs are tests developed by large, medium, small and specialized clinical labs such as Quest Diagnostics, LabCorp, Myriad Genetics, Genomic Health, Sequenom and many others. LDTs play an import role in health care, especially in delivering molecular diagnostic and genetic screening results and interpretation to clinicians. To date, there is no single registry source to track existing LDTs, and they continue to grow as labs deploy these high cost and high margin tests as rapid go-to-market strategies, since they do not require lengthy clinical trials and FDA approval. Now, the FDA has announced its intent to regulate LDTs.

At the June meeting of the American Society of Clinical Oncology, FDA Commissioner Margret Hamburg M.D. said that LDTs are “currently marketed without FDA premarket review to determine whether they are safe and effective, whether they are accurate and clinically valid. Many in the IVD (in vitro diagnostics) industry would agree.” She told Forbes magazine, “And that can be a problem.” Now that the FDA has put the lab industry on notice regarding its intent to regulate LDTs, it will likely have a negative impact on labs that market LDTs and IVD companies that provide automated systems and reagents to run these complex tests.

In response to Hamburg’s announcement, the American Clinical Laboratory Association (ACLA) filed a Citizen Petition challenging the FDA’s regulatory authority over LDTs. This is not the first Citizen Petition regarding LDTs. Several years ago, Genentech also filed a Citizen petition citing the high rate of false positive and negatives associated with Her2/neu Nu tests that are used as a companion diagnostic to determine patient suitability for Genentech’s trastazumab. There has been a long running debate on whether the FDA or CLIA regulates LDTs. If the FDA is successful in gaining and implementing regulatory authority over LDTs, it would be disruptive to labs, IVD manufacturers and patients alike.

For more information on the LDTs, companies with exposure involved and the high growth molecular diagnostics segment of the 52 billion dollar global clinical diagnostics market, please contact me through Zintro and schedule an individual discussion today.

Guest post by Zintro expert Ken Powell

President, Genesis Business Development

Zintro has experts in every industry sector, across every job function, in every geographic region. Recently, some of the following topics have seen inquiry activity: