FDA's Lab Test Overhaul: What It Means for Your Health and Lab Operations????

On September 29, 2023, the Food and Drug Administration (FDA) issued a proposed rule in which all lab tests, including laboratory-developed tests (LDTs), would be regulated as in vitro diagnostics (IVDs).

Let’s break it down:

For decades, there have been two types of patient sample tests in the U.S.—off-the-shelf, "commercial diagnostic tests" and what are called “laboratory-developed tests” (LDTs).

Unfortunately, proposed legislation called the?Verifying Accurate Leading-edge IVCT Development Act (VALID Act), is like a makeover for the rules that oversee both these types of tests. But, and it's a big "but," it might bring some unintended consequences.

FDA regulations define IVDs as:

reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae and intended for use in the collection, preparation, and examination of specimens taken from the human body

LDTs are a subset of IVDs that are designed, manufactured, and used within a single laboratory (i.e., a clinical lab with a single CLIA certificate).

Traditionally, labs were primarily regulated under CLIA (Clinical Laboratory Improvement Amendments). CLIA focuses on the quality of a lab's operations and ensuring that your tests are accurate.

Moreover, the FDA had a policy of "enforcement discretion" for most LDTs. This means that the FDA didn't actively regulate or require approval for most tests you created in your lab. They generally trusted CLIA to oversee your lab's practices.

But, even CLIA doesn’t dig deep into the nitty-gritty of the tests labs created.

And here's why that's not great.

Without standardized and rigorous checks, patient safety could be at risk. Labs could introduce LDTs without much scrutiny, leaving doubts about how accurate and reliable these tests are.

To put it in perspective, think of it like this: Imagine if different car manufacturers had their own safety standards. Some might have strict regulations, while others have looser rules. You'd never be sure how safe a car was unless it met a universal safety standard.

Similarly, inconsistent regulation for lab tests can lead to variations in quality between different labs, making it hard for patients and healthcare providers to trust the results.

This approach also discourages investment in R&D of high-risk tests, as there is uncertainty about regulatory requirements.

This policy of enforcement discretion arose because LDTs historically were perceived as low-risk due to their use in limited volumes primarily in rare diseases and generally with interpretation by a treating physician.

However, as the FDA describes in the Proposed Rule, over the past 50 years, LDTs have become

used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions

Okay, how is the new better for labs?

Meeting FDA standards enhances a lab's credibility, expands its market reach by attracting healthcare institutions and clinics seeking quality assurance, and positions your lab as a leader in the industry, giving it a competitive edge.

Additionally, compliance can lead to the expansion of service offerings, streamlined operations, and the potential for profitable partnerships and collaborations.

It may also make a lab eligible for federal funding and research opportunities. While achieving compliance involves investment, the long-term advantages in terms of reputation, market share, and sustainability can make it a profitable venture for a lab.

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