Related Experiment Video
Updated: Jul 25, 2026
23:56
Comprehensive & Cost Effective Laboratory Monitoring of HIV/AIDS: an African Role Model
Published on: October 31, 2010
17.4K
Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch
H Scheerens1, A Malong1, K Bassett1
1Genentech Inc., San Francisco, California, USA.
Clinical and Translational Science
|January 26, 2017
Summary
FDA-approved diagnostic assays are crucial for patient care, enhancing lifespan and quality of life. This tutorial explores strategies for developing companion or complementary diagnostic assays for regulatory approval.
Area of Science:
- Biomedical diagnostics
- Regulatory science
- Translational medicine
Background:
- FDA-approved diagnostic assays are vital in modern patient management.
- These assays support safe and effective therapeutic use (companion diagnostics) or optimize benefit/risk profiles (complementary diagnostics).
Purpose of the Study:
- To review strategic considerations for developing diagnostic assays.
- To guide the process for achieving FDA approval as companion or complementary diagnostics.
Main Methods:
- Review of regulatory pathways for diagnostic assays.
- Analysis of strategic decision-making in drug and assay co-development.
- Examination of factors influencing companion and complementary diagnostic approval.
Main Results:
- Diagnostic assays are increasingly integral to patient care and therapeutic strategies.
- Clear distinctions exist between companion and complementary diagnostic roles.
- Strategic planning is essential for successful regulatory submission and approval.
Conclusions:
- Developing FDA-approved diagnostic assays requires careful strategic planning.
- Understanding the roles of companion and complementary diagnostics is key.
- This review provides a framework for optimizing drug and assay development for regulatory success.
More Related Videos
Related Concept Videos
02:50Combination Therapies and Personalized Medicine
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
02:50Combination Therapies and Personalized Medicine
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
01:22Biopharmaceutical Factors Influencing Drug Product Design: Overview
Rational drug product design integrates knowledge of the drug’s physicochemical properties, formulation components, manufacturing techniques, and intended route of administration. Each factor influences the drug’s performance, including how it is released, absorbed, and eliminated in the body.The physicochemical properties of a drug—such as solubility, stability, and particle size—affect its compatibility with excipients and the choice of dosage form. Excipients, though pharmacologically...
01:24Automated Microbial Diagnostics
Automated diagnostic analyzers have transformed clinical microbiology by providing rapid and reliable methods for pathogen identification and antibiotic susceptibility testing. Among these systems, the Vitek 2 is widely used because it automates the traditionally labor-intensive processes of microbial identification (ID) and antibiotic susceptibility testing (AST), delivering standardized and timely results that are essential for effective patient care.Microbial Identification with ID CardsThe...