LDT / Central Lab Test Development, Regulatory Approval & Commercialization

The regulatory expertise of the KSL CRO business unit in conjunction with the clinical laboratory foundation of KSL Diagnostics offers a powerful model to rapidly develop and deploy novel diagnostics. KSL uses this model to deliver diagnostics developed internally for patient enrollment, clinical trial assays, laboratory developed tests (LDT) and CLIA central laboratory testing, as well as on behalf of our clients.

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This process can be fraught with challenges, related to compliance issues, licensing, access to clinical specimens for validation, delays in approval, obtaining reimbursement, and all of the associated costs. KSL provides the solution, with a fast path to regulatory approval and commercialization. Our clinical laboratories are CLIA, NYSDOH, CAP and ISO 15189 accredited. They offer broad testing platforms in oncology, immunology, infectious disease and ever-expanding fields with customizable capability to support clinical trials and reference laboratory testing.

KSL works with scientists and innovators to realize the promise of their technologies. We offer flexible business models to in-license or co-market promising diagnostics, as well as obtain regulatory approval and execute testing on a contract basis.

 

Recent examples include:

Laminin 332

Date of development / validation: March 2022
Model: In-house development.
Platform: Indirect immunofluorescence microscopy (IIF)

Background:

Clinically, patients with anti-laminin 332 mucous membrane pemphigoid (MMP) cannot be differentiated from patients with MMP with autoantibodies against the other main target antigen, BP180, and can only be distinguished by serological testing. Identification of MMP patients with laminin 332-specific antibodies are essential since 25%–30% of these patients may have a malignancy (Goletz, 2019). Detection and confirmation of these antibodies is challenging. To address the diagnostic needs of this high-risk population, KSL developed it Laminin 332 IIF method offering 84% sensitivity and 99% specificity.

Development:

This test was developed by KSL with specimens for analytical and clinical studies and regulatory submission contributed by KSL’s network of specialized clinical collaborators. Clinical recruitment, validation, clinical studies, regulatory submission and approval by New York State Department of Health was completed in less than 2 months.

Service Parameters:

Testing is provided throughout the United States through KSL’s Beutner Laboratories unit, which is specialized in immunodermatology. Beutner Laboratories offers the test as an LDT with standard reimbursement as an IIF method. Beutner Labs is CAP accredited with license to provide testing throughout the United States.

KSL Diagnostics is a national reference laboratory headquartered in Buffalo, New York. KSL Diagnostics is College of American Pathologists (CAP) accredited, CLIA licensed with additional state department of health licenses for testing throughout the United States, and certified to ISO 15189 by A2LA.