Laboratory Developed Tests (LDTs) are pushing the boundaries of molecular diagnostics, providing personalized, precise, and impactful healthcare solutions. In 2024, several companies are making significant strides in early disease detection, personalized medicine, and more. Here’s a look at the leading commercial labs that are shaping the future of LDTs and why they stand out in the industry.
Yemaachi Biotech
Yemaachi Biotech is leveraging multi-omics to advance personalized medicine by combining genomic, proteomic, and transcriptomic data. As an emerging commercial lab, Yemaachi is poised to offer LDTs that provide comprehensive, individualized treatment plans. Their approach to personalized medicine could result in some of the most innovative laboratory developed tests focused on tailored healthcare solutions.
PrognomiQ
PrognomiQ is exploring liquid biopsy technology for early cancer detection. This commercial lab is still in development, but their use of AI-driven analytics to enhance accuracy makes them a promising name in oncology diagnostics. PrognomiQ’s potential contributions to non-invasive cancer screening could lead to new and impactful laboratory developed tests as they advance.
Natera
Natera leads the way in non-invasive prenatal testing (NIPT) with their Panorama test, showcasing their expertise in LDTs. This commercial lab uses cell-free DNA technology to assess genetic risks, offering essential insights to expectant parents without invasive procedures. Natera also offers the Signatera™ test for minimal residual disease (MRD) detection in cancer, strengthening their role in personalized medicine. These tests are some of the most advanced laboratory developed tests available today.
Myriad Genetics
Myriad Genetics is a pioneer in hereditary cancer testing, particularly with their BRACAnalysis CDx LDT. This commercial lab provides critical genetic information that guides personalized treatment and prevention strategies for cancer. Myriad Genetics sets the standard in genetic testing, making them a cornerstone in the industry and a model for other laboratory developed tests.
Veracyte
Veracyte has made a major impact in genomic diagnostics with their Afirma® Thyroid FNA Analysis. This commercial lab helps reduce unnecessary surgeries by providing precise diagnostic information to determine whether thyroid nodules are benign or malignant. Veracyte’s commitment to improving diagnostic accuracy and patient outcomes makes them a key player in the LDT space, offering effective laboratory developed tests in cancer diagnostics.
Invitae
Invitae is working to make genetic testing more accessible with their Comprehensive Hereditary Cancer Test. As a growing commercial lab, Invitae focuses on affordability and accessibility, enabling more people to benefit from genetic insights. Their wide range of LDTs covers multiple hereditary conditions, making Invitae a critical player in expanding the reach and impact of laboratory developed tests.
Freenome
Freenome is developing multiomics-based LDTs focused on early cancer detection. Their approach integrates genomics, proteomics, and machine learning to set a new standard in non-invasive cancer screening. As an emerging commercial lab, Freenome’s innovative use of biological data positions them to introduce groundbreaking laboratory developed tests in the near future.
FYR Diagnostics
FYR Diagnostics specializes in RNA-based LDTs for the early detection of infectious diseases and cancer. Their expertise in RNA technology makes them a rising commercial lab in the diagnostic space. FYR’s precision and early detection capabilities position them as an important contributor to the evolving landscape of laboratory developed tests.
AoA Dx
AoA Dx is tackling the early detection of ovarian cancer, one of the most challenging areas in cancer diagnostics. Their test, called TERESA, is a blood-based diagnostic in development that aims to revolutionize how ovarian cancer is detected and treated. AoA Dx’s commitment to this critical area in women’s health could lead to laboratory developed tests that save lives through earlier detection.
Scispot: Supporting the Future of Laboratory Developed Tests
Scispot provides a comprehensive platform designed to help modern laboratories manage their Laboratory Developed Tests (LDTs) effectively. Here’s how Scispot specifically supports compliance with new FDA requirements:
- Automated Compliance Tracking: Scispot enables laboratories to automate the tracking of compliance-related tasks, ensuring that every aspect of the LDT process adheres to the latest FDA guidelines. This includes automating the creation of audit trails, generating compliance reports, and setting up alerts for upcoming regulatory deadlines, which helps labs stay on top of evolving regulations.
- Document Management and Control: Scispot’s platform ensures that all documentation related to LDTs is organized, controlled, and easily accessible. This is crucial for meeting FDA requirements around document control, including the proper handling of standard operating procedures (SOPs), quality manuals, and regulatory submissions. Scispot’s document management features include version control, approval workflows, and secure access, which help labs maintain compliance with FDA regulations.
- Quality Management Integration: Scispot integrates quality management directly into the LIMS/LIS workflow, ensuring that quality control measures are applied consistently throughout the LDT development process. This includes tracking and managing non-conformances, corrective and preventive actions (CAPA), and customer complaints—all of which are key components of the FDA’s quality system regulations.
- Data Integrity and Security: The FDA places a strong emphasis on data integrity in the development of LDTs. Scispot ensures that all data generated and stored within the platform is secure, traceable, and compliant with FDA data integrity guidelines. Features such as electronic signatures, secure access controls, and detailed audit trails provide the necessary safeguards to protect data integrity and ensure compliance.
- Validation and Verification Support: Scispot supports the validation and verification processes required by the FDA for LDTs. The platform helps labs document and manage validation protocols, test plans, and results, ensuring that all LDTs meet the necessary performance criteria before they are deployed in a clinical setting.
- Customizable Workflow Management: Scispot allows laboratories to customize their workflows to meet specific FDA requirements. This flexibility ensures that labs can adapt quickly to new regulations without the need for extensive reprogramming. Whether it's adjusting processes for new FDA guidance or implementing changes required during an audit, Scispot’s platform provides the tools needed to maintain compliance.
- Training and Competency Tracking: Scispot includes tools for managing staff training and competency, which is a critical aspect of FDA compliance. The platform helps labs track training records, assign training modules, and ensure that all personnel involved in the LDT development process are qualified and up-to-date with the latest regulatory requirements.
By focusing on these critical areas, Scispot empowers laboratories to meet the new FDA requirements for LDTs, ensuring that their tests are safe, effective, and compliant with the highest industry standards.
In 2024, the commercial labs leading the development of Laboratory Developed Tests (LDTs) are shaping the future of molecular diagnostics. These companies are making significant strides in diagnostic technologies, improving how we detect, monitor, and treat diseases. The laboratory developed tests highlighted here show how these commercial labs are transforming healthcare, supported by platforms like Scispot that help drive this progress.
