BioAgilytix

BioAgilytix

Global bioanalytical testing for drug development

Overview

BioAgilytix is a global bioanalytical laboratory that provides testing services for pharmaceutical, biotechnology, and agricultural biotech companies, with a notable presence in Hamburg, Europe. It specializes in large-molecule studies and runs assays such as pharmacokinetics, pharmacodynamics, cell-based tests, and immunogenicity to measure how drugs behave in the body and assess safety and efficacy. The company offers customizable, service-based testing that supports drug development from research through regulatory approval, including COVID-19 testing packages. Its differentiators are its global reach, deep expertise in large-molecule workflows, and a flexible model that partners with clients on a project basis. Its goal is to deliver precise, validated bioanalytical data that helps clients develop and bring new therapies to market.

About BioAgilytix

Simplify's Rating
Why BioAgilytix is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Food & Agriculture

Biotechnology

Healthcare

Company Size

501-1,000

Company Stage

Growth Equity (Venture Capital)

Total Funding

$30.1M

Headquarters

Durham, North Carolina

Founded

2008

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Simplify's Take

What believers are saying

  • FDA BDD in 2026 strengthens BioAgilytix’s reputation in gene-therapy bioanalysis.
  • May 14, 2026 GMP capacity gains give sponsors faster regulatory-ready testing in two geographies.
  • A3P’s U.S. Stockholm3 partnership extends BioAgilytix into prostate-cancer diagnostics revenue.

What critics are saying

  • BioAgilytix canceled North Carolina’s 878-job JDIG in March 2024 after biotech funding weakened.
  • BioAgilytix is fighting a 2025 First Circuit trade-secrets case against James McNally and Sword Diagnostics.
  • A prolonged biotech funding slump crushes utilization and blocks the headcount growth needed to justify expansion.

What makes BioAgilytix unique

  • BioAgilytix won FDA Breakthrough Device Designation in February 2026 for Lexeo’s AAV assay.
  • Its Morrisville and Hamburg GMP expansions support regulated QC across development and commercialization.
  • The 2024 Cambridge Biomedical acquisition deepened large-molecule bioanalysis capacity in Boston.

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Funding

Total Funding

$30.1M

Above

Industry Average

Funded Over

1 Rounds

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Company Match

Parental Leave

Employee Referral Bonus

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

12%
BioAgilytix
Mar 24th, 2026
BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award.

BioAgilytix celebrates Jessica Bridges Weaver for scientific leadership with 2026 TBJ Award. Durham, N.C. - March 24, 2026 - BioAgilytix, a global leader in bioanalytical services, is proud to celebrate its commitment to scientific excellence and leadership with Jessica Bridges Weaver, Scientific Officer, who has been named a 2026 Triangle Business Journal Women in Business Award Winner. With more than 20 years of experience across pharmaceutical manufacturing and analytical testing, Jessica has played a critical role in strengthening BioAgilytix's scientific and regulatory leadership. In her role, she partners closely with global laboratory and business development teams to advise clients on phase-appropriate, regulatory-ready testing strategies for complex biologics. Her work extends to assay design and troubleshooting, ensuring methods align with both client objectives and evolving global regulatory expectations. Her impact has been especially evident in the strategic expansion of BioAgilytix's CMC analytical testing services in the Research Triangle Park hub, as well as the global growth of GMP bioassay capabilities and the development of specialized infrastructure in Hamburg, Germany. Beyond operational leadership, Jessica is a recognized thought leader in CMC analytics and bioanalysis who produces and delivers webinars, conference presentations, and peer-reviewed publications that promote continuous learning and knowledge-sharing across the life sciences community. "Jessica exemplifies the scientific rigor, integrity, and collaborative leadership that defines BioAgilytix," said Davide Molho, Chief Executive Officer of BioAgilytix. "Her ability to translate complex science into meaningful impact for our clients and the industry makes her an outstanding leader and a deserving recipient of this recognition." In addition to her professional achievements, Jessica is deeply committed to community service and mentorship. She actively supports STEM education initiatives, mentors high school students, and partners with organizations focused on pediatric care and child welfare. Her work reflects a lifelong commitment to stewardship, integrity, and expanding access to opportunities for future generations. "It is truly an honor to be recognized alongside so many inspiring women," said Jessica Weaver. "This recognition reflects the incredible teams I am privileged to work with at BioAgilytix and our shared commitment to advancing science, strengthening communities, and improving patients' lives. I am grateful for the opportunity to contribute to work that creates meaningful impact for our clients and the broader life sciences community." Jessica's recognition represents the strength of the BioAgilytix community, and a culture built on collaboration, integrity, and scientific excellence. About BioAgilytix BioAgilytix is the trusted partner for bioanalytical services throughout every phase of the drug development process. As a leading global bioanalytical laboratory, the company provides established and emerging pharmaceutical and biotechnology organizations with pharmacokinetic (PK), immunogenicity, biomarker, and CMC analytical testing services in a GxP environment. BioAgilytix maintains state-of-the-art laboratories in Durham, North Carolina; Boston, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia; and Hamburg, Germany. For more information, please visit www.bioagilytix.com.

Associated Press
Feb 10th, 2026
BioAgilytix receives FDA breakthrough device designation for anti-AAV antibody assay supporting gene therapy

BioAgilytix Labs has received FDA Breakthrough Device Designation for its anti-AAV antibody assay supporting Lexeo Therapeutics' gene therapy programme for Friedreich ataxia cardiomyopathy, a rare progressive disorder affecting approximately 15,000 people worldwide. The plate-based MSD anti-adeno-associated virus serotype rh.10 total antibody assay enables precise patient selection and monitoring for gene therapy programmes. The FDA's Breakthrough Device Designation expedites development and review of novel medical devices treating life-threatening or irreversibly debilitating conditions. BioAgilytix is among a limited number of contract research organisations to receive breakthrough designation for a diagnostic assay supporting an investigational device exemption. The Durham, North Carolina-based company operates laboratories across the US, Australia and Germany, providing bioanalytical testing services for pharmaceutical and biotechnology organisations.

Rapid Test Methods Ltd
Jun 18th, 2024
BBI and BioAgilytix Partner to Streamline and Simplify Bioanalytical Testing

BBI Solutions OEM Limited (BBI), a trusted expert provider of end-to-end solutions for the development of high-performance assays, has signed a partnership agreement with BioAgilytix, a leading global bioanalytical laboratory.

The Business Journals
Mar 26th, 2024
Durham firm cancels deal that promised 878 jobs

BioAgilytix in 2020 picked the Triangle over competing sites in Massachusetts for a $61.5 million expansion that was expected to add 878 local jobs.

GenomeWeb
Sep 13th, 2023
A3P Biomedical, BioAgilytix Partner to Bring Prostate Cancer Test to US

NEW YORK - Swedish diagnostics firm A3P Biomedical announced on Wednesday that it has partnered with BioAgilytix to bring A3P's prostate cancer test to the US as a laboratory-developed test.

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