Our Mission: Your Success.
DEVLAB BIO’s mission is simple. To help you change the world for the better. We believe you can do it and we know we can help.
Our deep commitment to your success stands on these four pillars:
Integrity
Quality
Customer Service Excellence
Scientific Expertise
How we do it
We do this and do it well by forging two paths that converge. We provide a full-service solution for clients needing both a CAP/CLIA Diagnostics and Contract Research facility. Our highly-skilled and patient-focused Clinical Diagnostics team provides clinical laboratory testing in our CAP/CLIA-accredited facility. With onsite collection for patient samples, we serve customers both regionally and throughout the country.
While our clinical diagnostics customers are both regional and throughout the country, our CRS serves the global community. CRS provides development and commercialization of concepts, support and development toward FDA 510(k), EUA approval and LDT development. Furthermore, they process samples as a Clinical Test Site. Our contract research is not limited to only clinical diagnostics, we cast a wide net. We work with medical device, cosmetic, and the food and beverage industries too.
Our scientists and staff deliver a cost-effective solution while focusing on Integrity, Customer Service Excellence and Quality Results
About DevLab BIO
DevLab bio is a skilled and experienced laboratory services organization with expertise in chemistry, immunology, molecular diagnostics, and genomics. We provide Contract Research Laboratory services at a more personal level than you can expect from large CROs. We are hassle-free. DevLab bio can help you in vetting your project and assessing the best way to approach the marketplace, whether that be by evaluation of the laboratory developed test strategy, or approaching the US Food and Drug Administration via its 510(k) and PMA processes. Our scientists and staff have deep knowledge in the field; we can perform your needed laboratory work, source specimens, devise tactics consistent with your go-to-market strategy, offer expert regulatory and business advice.
We also offer clinical laboratory testing in our CLIA-certified, CAP-accredited clinical laboratory. Our clinical laboratory director, Dr. Daniel H. Farkas, has over thirty years of experience in laboratory medicine and molecular diagnostics.
How It Fits Together
Our CONTRACT RESEARCH SERVICES team provides a full suite of resources from laboratory services and test development to support for product development projects. We can initiate projects quickly, reduce risks and avoid unnecessary costs. We work closely with our Clinical Diagnostics team to coordinate clinical projects that require and benefit from both a research laboratory and a CAP/CLIA facility.
Our CLINICAL DIAGNOSTICS (CDx) team supports and works closely with Contract Research Services and provides clinical diagnostic testing both regionally and throughout the country. We support clinicians with a growing test menu to help diagnose their patients and we are in network with many medical insurance companies. Additionally, we provide direct-to-consumer testing to our regional patients and have onsite collection for laboratory tests for those that chose not to utilize insurance and need a direct pay option.
As a matter of fact, we focused heavily on direct-to-consumer patients during the COVID pandemic and rose to the occasion to support our local communities by providing Covid-19 testing (RT-PCR, antibody testing and our patent-pending protective antibody test). We have provided testing throughout the pandemic and will continue to support our local physicians and patients with a quick-turnaround test option. Currently, our CDx team has an extensive menu of allergy and autoimmune diagnostic tests.
Designed with You in Mind
We provide the necessary resources to design an assay or develop a series of tests to confirm benchmarks for your project. We work with our clients to develop and support commercialization of their product with a comprehensive services suite. Our services include Molecular Diagnostics and Immunoassay providing a range of development services. Unlike the traditional CRO, our agility and flexibility benefits both small and large customers. We assist with experimental design and have the facilities and capabilities to take a customer’s idea from concept to commercialization in a variety of industries.
DEVLAB BIO’s commercialization support includes evaluating technologies, scientific and product expertise support, project management and laboratory facilities for building and testing products. DevLab provides business infrastructure and marketing guidance. Furthermore, we provide IP support and operate with regulatory expertise in CAP/CLIA, GLP/GMP and ISO compliance.
Quality Control
DEVLAB BIO is a CAP/CLIA laboratory and currently performs all services adhering to Good Laboratory Practices (GLP).
ISO 17025 accreditation expected in 2022.