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Why Choose LDT?

LDTs offers flexibility and rapid adaptions to tailor specific patient needs and emerging conditions comparing to IVD.

Customization: Labs can develop LDTs in-house, allowing for customization and adaptation to specific patient populations or unique needs.

Rapid: LDTs can be developed and implemented more rapidly compared to IVD tests, especially in response to emerging diseases or unique patient cases.

Lower Cost: Generally, LDTs tend to be less expensive to develop and perform due to less stringent regulatory requirements.

Flexibility: Labs have more flexibility to tweak and modify tests based on emerging scientific knowledge or patient-specific requirements.

Regulation: IVD tests are strictly regulated by the FDA for safety, efficacy, and quality control.

Standardization: IVD tests follow strict guidelines and standardized protocols, ensuring consistency and reliability in results.

Validation: Rigorous validation and clinical trials are required before approval, enhancing confidence in IVD tests’ accuracy.

Wider distribution: IVD tests have less restrictions in distribution, they are widely available in the market due to standardized production processes.

Latest Development of LDT

Quest Diagnostics to Acquire PathAI Diagnostics to Accelerate AI and Digital Pathology Adoption in Cancer Diagnosis

Hopkins Medtech｜May. 13, 2024

FDA issuing Final Rule on regulating LDT

Hopkins Medtech｜May 11, 2024

Pillar Biosciences’ OncoReveal CDx Test Receives Expanded FDA Approval

Hopkins Medtech｜Apr. 30, 2024

Molecular You Discloses Significant Advancement in Early Pancreatic Cancer Detection

Hopkins Medtech｜Apr. 29, 2024

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Laboratories Face Challenges Establishing and Implementing LDTs

Lengthy and complex regulation process

Lack of expertise in LDT validation

Upfront and spiraling costs

Complexity of LDT design

Difficulties in obtaining high quality reagents

Staff training and quality assurance

Allow our expertise to streamline your LDT validation steps

Our validation services makes your LDTs easier

Our experts seamlessly become part of your team to validate new tests for almost any test menu, without impacting your current operations.

Pre-Analytical Validation
Analytical Validation
Clinical Validation
Clinical Utility

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Why Hopkins MedTech Lab Services

Expertise in LDT Validation

With a team of experienced Lab Directors in a wide range of LDTs

Reduce Cost Substantially

Assist with high quality reagent and instrument sourcing in a cost-effective manner

Comprehensive Support

We understand the challenges faced by small to midsize labs and provide a range of services tailored to them

Global Sourcing and Supply Chain Capability Reagents and Instruments

Reagents

Instruments

30%

Cost Deduction

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