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About BioAgilytix
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
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.
Simplify's Take
What believers are saying
- Gene therapy market expansion as anti-AAV assay addresses rare disease diagnostics.
- European market growth through Hamburg lab qPCR expansion and leadership hires.
- Strategic partnerships with BBI Solutions and A3P Biomedical diversify revenue streams.
What critics are saying
- Cancelled $61.5M Durham expansion forfeits 878 jobs, damaging talent acquisition capacity.
- Charles River and Labcorp undercut pricing via integrated CRO scale advantages.
- Eurofins AI-optimized assays deliver 40% faster turnaround, threatening biotech client retention.
What makes BioAgilytix unique
- FDA Breakthrough Device Designation for anti-AAV antibody assay supporting gene therapy.
- Global laboratory network across US, Australia, Germany enabling early-phase to market authorization.
- Specialized expertise in large molecule bioanalysis, immunogenicity, and cell-based assays.
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Funding
Total Funding
$30.1M
Above
Industry Average
Funded Over
1 Rounds
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
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 18%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.
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.
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.
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.
Recognizing the critical need for improved prostate cancer diagnostics, A3P Biomedical and BioAgilytix have joined forces to introduce Stockholm3 as a novel LDT in the US market.
BioAgilytix is Hiring for 10 Jobs on Simplify!
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About BioAgilytix
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
BioAgilytix is Hiring for 10 Jobs on Simplify!
Find jobs on Simplify and start your career today