
Trace Custer
SVP Quality and Regulatory, OraSure Technologies
The U.S. FDA released a final rule to regulate laboratory developed tests (LDTs) on May 6, 2024, making it clear that such tests are classified as in vitro diagnostics (IVDs) and are subject to oversight by the agency. The phaseout of its general enforcement discretion approach for LDTs will happen in stages over a four-year period. IVDs manufactured by laboratories will generally fall under the same enforcement approach as other IVDs. The FDA will continue to exercise enforcement discretion for LDTs that have been approved by New York State’s Clinical Laboratory Evaluation Program (CLEP) — a specific subset of LDTs at the VHA, DoD and blood institutions — and for LDTs that have been on the market prior to the issuance of the final rule. Under the new rule, LDTs may incur significant new costs to comply with specific quality system requirements, such as design control, and will require the regulatory burden of LDT submission to the FDA for approval as an IVD. As a provider of sample collection devices — a critical preanalytical input into your clinical laboratory test system — we are here to answer your questions and to help navigate the complexity of the new rule.
- What are some significant challenges labs face in submitting LDTs for approval under the new U.S. FDA rule?
With the final rule, the FDA has provided a four-year implementation plan, which is intended to give laboratories time to build the required systems. This plan has been challenged by the American Clinical Laboratory Association (ACLA), which represents U.S. laboratories, because of the additional requirements beyond those already legislated by Clinical Laboratory Improvement Amendments (CLIA), College of American Pathologists (CAP) and New York State (NYS). Some key challenges include the requirement to implement quality systems, incurring costs associated with submissions to the FDA, limited in-house regulatory personnel and expertise, and concerns about the ability of the FDA to handle the influx of new submissions from labs across the country.
- What are the strategic considerations for labs or assay developers that plan to bring a genetic test or molecular diagnostic to market?
Beginning with the regulatory pathway, it’s important to identify which classification a test falls into, along with its indications for use. This is specific to the test and identifies the target market (e.g., is it a specific molecular diagnostic or is it for a broad population?). Then comes the process of analytical and clinical validation, a critical component within the FDA premarket review process, which provides the evidence, such as validation data, to support claims behind a test. A key area of focus should be the resources and expertise within or outside your organization to navigate the new rules.
- DNA Genotek Inc. manufactures sample collection devices that have 510(k) clearances and De Novo Authorization from the U.S. FDA. How does the regulatory status benefit the labs using these devices?
We have over 20 years of proven expertise in developing, validating, registering with the FDA and manufacturing collection devices. Our FDA-cleared devices give our customers confidence in the quality of our products and the assurance of compliance with FDA requirements.The Oragene™•Dx and ORAcollect™•Dx collection devices for DNA from saliva have general clearance for Rx and OTC use. The OMNIgene™•GUT Dx device is the first and only FDA-authorized collection device for bacterial DNA for gut microbiome profiling (via the De Novo pathway). Using these devices in tests saves time and costs for laboratories that want to leverage an FDA cleared
saliva/microbiome collection device into their methodologies for both supervised (e.g., prescription) and unsupervised at-home collection.
- Can you elaborate on the rigorous process involved in obtaining U.S. FDA clearance for sample collection devices and how labs can gain from your experience?
We have over 15 years of experience creating products that have passed the scrutiny of the U.S. FDA IVD clearance process. We are also ISO 13485 certified as an IVD/medical device manufacturer and have an outstanding quality track record of product performance with our customers.For example, the Oragene™•Dx and ORAcollect™•Dx devices manufactured by DNA Genotek™ have been cleared through the FDA 510(k) process. To do this, we performed robust validation of these devices and conducted User Comprehension Studies1,2 to demonstrate their ease of use for at-home DNA saliva collection and their technical performance.- U.S. Food and Drug Administration. (2020). The Oragene™•Dx DTC user comprehension study, K192920.
- U.S. Food and Drug Administration. (2022). The ORAcollect™•Dx DTC user comprehension study, K212745.
- Are there specific features of your sample collection solutions and service offerings that address LDT compliance needs?
Sample collection devices fall within the preanalytical part of an LDT system. These products have been cleared with the intent to provide reliable sample collection as input into your clinical laboratory test system. We have the expertise and data to support you in qualifying various sample types, including saliva, stool and urine, in your laboratory workflow and to help support your FDA compliance requirements.Our regulatory experts understand not only the requirements for IVD manufacturers of collection devices but also the clinical laboratory test systems and new regulatory requirements that LDTs are subject to and how to comply with them. Our customization services have your workflow in mind, and we intend to make it easy to integrate our FDA-cleared/FDA-authorized sample collection devices into your laboratory testing workflows.
- What documentation, protocols or other evidence can labs rely on when validating the use of DNA Genotek™ FDA-cleared/FDA-authorized devices with their assay?
Each of our registered products is supported with quality documentation that you need to support your clinical laboratory developed tests (LDTs) that are or will be classified as IVDs.Our products have the appropriate labels and supporting validations that support the assurance of quality, shelf life and stability. We provide registration packages for countries of interest that allow registration as the legal manufacturer as well as supporting documentation resources for a quality management system (QMS). Some examples of tests that have leveraged the DNA Genotek™ collection devices include the Helix® Laboratory Platform, a whole exome sequencing platform, and the Grifols AlphaID™ At Home Genetic Health Risk Service.
- Do you offer labs or assay developers your capabilities to help understand and implement compliance measures?
From providing the sample collection devices that form part of the preanalytical test system to comprehensive expertise and quality documentation, we will support labs to successfully navigate the transition to LDTs to comply with the new FDA regulations.Contact DNA Genotek directly to set up a call with one of our regulatory experts.
Phone: 1 (866) 813-6354
Email: info@dnagenotek.com
Contact DNA Genotek to learn more about how our experts can guide your journey to compliance. Click to learn more here.
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