By Nicholas Smith

Today there is much discussion on the Food and Drug Administration (FDA) regulation and oversight of Laboratory Developed Tests (LDTs). The debate features numerous topics including the necessity for regulation, whether the FDA has the authority to regulate, the feasibility of the proposed regulations, and the effect on innovation if indeed regulation is put into place.

Debate on lab developed tests and FDA regulations in IVD market

With the ultimate goal of regulation being the prevention of harm, there needs to be a balance between guaranteeing the safety of new medical technologies and the drive to develop new and better clinical tools. Will regulations and enforcement stifle the innovation that yields new technologies that result in clinical tools? How can IVD medical device manufacturers and OEM partners such as Tecan participate in this debate to provide value to its customers?

Laboratory Developed Tests (LDTs) in the IVD market

A major focus in IVD today is cancer and personalized medicine, specifically creating custom treatment for an individual’s genes… the key word being individual. These type of tests are not currently served by off-the-shelf testing. This brings us to a pivotal question which is at the heart of the regulation debate: Are LDTs medical devices or are they merely results? An LDT is an in vitro diagnostic (IVD) test that is created and used within an individual lab. Typically, a laboratory instrument is combined with reagents to create a specific test protocol, which goes on to be validated to provide a clinical diagnostic result.

Working with an OEM partner can be helpful

In these situations working with an original equipment manufacturer (OEM) that has experience in the highly regulated in vitro diagnostic (IVD) medical device market can be helpful. Tecan has the experience of being a regulated medical device manufacturer, and can serve in an advisory role to facilitate the process. Tecan offers equipment in both the clinical off-the-shelf area and develops customized systems.

Whether the need calls for existing modules and components or the development  of a customized instrument, Tecan can provide instrument testing and validation with the appropriate documentation necessary for FDA regulation. Tecan has a strong record of FDA compliance and has an extensive regulatory team including external consultants with FDA experience.

Today, 80% of Tecan partners operate in the IVD market, each successfully going through the FDA submission, verification, and validation process. Platforms such as the Freedom EVOlyzer, a validated solution for automation of microplate­based chromogenic ELISAs, and the Freedom EVO Clinical, Tecan’s IVD-D compliant (98/79/EC) open liquid handling platform, have undergone this rigorous process.

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