
Diagnostics
Tailored Guidance Based on Niche Sector Knowledge
As an aging population and rapid scientific advancements drive continuous growth in the market, we help clients adapt and thrive. Clinical laboratories and diagnostic test developers rely on Mintz daily. We keep clients compliant with state and federal health regulations. Aid them in their acquisition and disposition of business and technical assets. Help access capital. Assist in developing and implementing personnel management systems. Respond to government inquiries. And so much more.
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Our Approach
We view the diagnostics sector holistically. We understand its complexities from the perspective of practitioners as well as service providers. Our team includes some of the country's most experienced health regulatory and transactions professionals — including an attorney who is board certified to run a diagnostics lab, professionals who worked in-house for years, and colleagues whose near sole focus is serving the diagnostics industry. Together, we offer cross-disciplinary solutions, collaborating with professionals from the health regulatory, policy advocacy, litigation, transactions, and intellectual property teams.
Our clients include diagnostics manufacturers, reagent developers, clinical laboratories, imaging service providers, and other operators. We deliver sound advice to each client based on experience as well as our understanding of each company's business goals.
- Fraud and abuse advice and defense
- Medicare / Medicaid reimbursement
- Intellectual property strategy and counseling
- Collaboration and licensing agreements
- Mergers and acquisitions
- Regulatory counseling
- Policy advocacy
- Capital markets and securities
- Financing - private and public
- Employee policy development and implementation
- Clinical laboratories
- Diagnostics manufacturers
- Reagents developers
- Imaging services
Meet Mintz
Our team includes some of the country's most experienced health regulatory and transactions professionals.
Our Insights
Viewpoints

FDA Is Accepting EUA Requests for Monkeypox Tests, But Time is of the Essence
September 28, 2022 |Blog

Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?
June 2, 2022 |Blog
News & Press
Related Practices
- Health Care Transactional Due Diligence
- Medicare, Medicaid & Commercial Coverage & Reimbursement
- Patent Prosecution & Strategic Counseling
- Patent Litigation
- Licensing & Technology Transactions
- Mergers & Acquisitions
- FDA Regulatory
- Health Care Compliance, Fraud & Abuse, and Regulatory Counseling
- Clinical Trials & Research
- Employment Litigation & Arbitration
- Data & Privacy Litigation and Investigations
- Health Care Enforcement & Investigations