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Paths to Consider When Commercializing Your LDT

Paths to Consider When Commercializing Your LDT

by Alex Mitchell | Dec 19, 2024 | Adding Lab Testing & LDTs, Tips for New Lab Owners, Industry Insights, Clinical Laboratory

UPDATE: On May 6, 2024, FDA issued a new rule amending the regulatory definition of in vitro diagnostic (IVD) device to include laboratory-developed tests (LDTs) and ending the agency’s longstanding policy of generalized enforcement discretion. However, on March 31,...
The Benefits of Adding NGS Testing in Your Laboratory

The Benefits of Adding NGS Testing in Your Laboratory

by Alex Mitchell | Nov 19, 2024 | Adding Lab Testing & LDTs, Lab Operations & Management, Billing & CPT Codes, Revenue Cycle Management, Industry Insights

As advancements in molecular diagnostics continue to evolve, next-generation sequencing (NGS) testing represents an exciting opportunity for physician-owned laboratories to expand their services. Beyond providing cutting-edge insights into oncology and OB-GYN care,...
Analytical Lab Testing Requirements for Cannabis Labs in California

Analytical Lab Testing Requirements for Cannabis Labs in California

by Alex Mitchell | Jul 8, 2024 | Adding Lab Testing & LDTs, Industry Insights, Clinical Laboratory

The cannabis industry has experienced rapid growth and change in recent years. As more states legalize medical and recreational cannabis use, strict regulations and testing requirements have been implemented to ensure the safety and consistency of these products. To...
Analytical Lab Testing Requirements for Cannabis Labs in Colorado

Analytical Lab Testing Requirements for Cannabis Labs in Colorado

by Alex Mitchell | Jul 8, 2024 | Adding Lab Testing & LDTs, Lab Operations & Management, Industry Insights

The cannabis industry has experienced rapid growth and change in recent years. As more states legalize medical and recreational cannabis use, strict regulations and testing requirements have been implemented to ensure the safety and consistency of these products. In...
What is Surveillance Testing and How Does it Work?

What is Surveillance Testing and How Does it Work?

by lighthouselab | Apr 26, 2024 | Clinical Laboratory, Adding Lab Testing & LDTs, Lab Operations & Management, Industry Insights

How does clinical lab surveillance testing differ from other types of COVID-19 testing? While individual diagnostic testing is primarily designed to track and verify COVID-19 positivity in those who have contracted the SARS-CoV-2 coronavirus, surveillance testing...
Navigating Medical Necessity for PCR Testing

Navigating Medical Necessity for PCR Testing

by lighthouselab | Apr 15, 2024 | Adding Lab Testing & LDTs, Lab Operations & Management, Denial Management, Revenue Cycle Management, Industry Insights

It’s essential for referring providers considering large panel tests to grasp the nuances of Medicare National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs) in order to effectively navigate medical documentation requirements. Without...
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