FDA Oncology Pilot Program: A New Resource for Diagnostic Testing Companies

The FDA has recently launched a new pilot program designed to improve the accuracy and reliability of diagnostic tests used in oncology. The FDA Oncology Pilot Program is open to drug product sponsors concerning CDER-regulated oncology drug products for which the FDA determines that an in vitro diagnostic test is needed to identify the intended patient population.

The program is designed to provide test developers with increased transparency regarding the minimum performance necessary for in vitro diagnostic tests used with oncology drug products. This will help diagnostic testing companies design and validate accurate and reliable tests. The program may also streamline the validation process for additional tests of the same type.

The FDA Oncology Pilot Program is a valuable resource for diagnostic testing companies. The program can help these companies design, validate, and bring to market accurate and reliable tests to improve patient care.

How the FDA Oncology Pilot Program Can Benefit CLIA Labs

The FDA Oncology Pilot Program can benefit CLIA labs in several ways.

First, the program increases transparency regarding the minimum performance necessary for in vitro diagnostic tests used with oncology drug products. This can help CLIA labs design and validate accurate and reliable tests.

Second, the program may streamline the validation process for additional tests of the same type. This can save CLIA labs time and money.

Third, the program can help CLIA labs to ensure that their tests are used following FDA guidance. This can help to protect patient safety.

If you are a CLIA lab interested in learning more about the FDA Oncology Pilot Program, please visit the FDA website for more information.

References :

• FDA Oncology Pilot Program: https://www.fda.gov/medical-devices/in-vitro-diagnostics/oncology-drug-products-used-certain-in-vitro-diagnostics-pilot-program
• FDA Guidance for Industry: Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: https://www.fda.gov/media/160186/download