BioAgilytix Diagnostics

Specialized Diagnostic Testing to Meet Your Quality & Timeline Demands

When you need a partner to deliver reliable lab results quickly, working within the context of your regulatory quality and turnaround time requirements, turn to BioAgilytix Diagnostics. If tailored testing and responsive service matter to you, there is no better provider.

A division of BioAgilytix and part of our CLIA-certified, CAP-accredited, New York State-licensed Boston laboratory, BioAgilytix Diagnostics provides diagnostic testing services to reference labs nationwide. We work with a diverse range of clinical samples, accepted from all 50 states. Our biomedical testing solutions are delivered with specialized knowledge and a personalized approach, ensuring expedient analysis, accurate results, and reporting customized to your workflows.

Have immediate diagnostic testing needs?

We’re ready to help. Call 1.617.456.0800 or
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Diagnostic Specialty Areas

We specialize in esoteric testing using FDA-cleared assays and laboratory-developed tests (LDTs), and uphold a more than 20-year track record delivering diagnostic testing service results that stand up to regulatory scrutiny. We’re ready to fulfill your biomedical testing needs, whether routine or complex, using state-of-the-art technology and a proven team of clinical diagnostic experts.

Infectious Disease Testing

For pathogen detection and surveillance

BioAgilytix Diagnostics’ real-time PCR system provides maximum multiplexing capabilities and high detection sensitivity and specificity in testing for pathogens, such as SARS-CoV-2 and HIV. Target DNA or RNA can be extracted and amplified from a variety of sample types, including serum, plasma, and swabs.

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Diagnostic Immunology

To identify and evaluate immune responses

Immunoassays are used to detect and measure patient antibody responses to bacteria, parasites, and viruses, including IgG, IgM, and IgA antibodies in serum, plasma, or cerebral spinal fluid (CSF). With semi-quantitative testing via titers, we can also evaluate strength of immune response.

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Vitamin Testing

To identify vitamin deficiencies or disorders

Our assessments performed in serum or plasma help identify vitamin deficiencies or disorders affecting nutrition or cell function, and to provide guidance for patient management once diagnosed.

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Parasite-Borne Infection Testing

To test for the presence of IgG and IgM antibodies

Because of BioAgilytix Diagnostic’s location in the Northeast, our laboratory is very experienced in testing for tick-borne infections, including Lyme disease (B. burgdorferi) as well as arboviruses transmitted via a variety of insects. Testing can be performed in serum, plasma, or CSF.

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Laboratory-Developed Tests (LDTs)

BioAgilytix diagnostic testing services also validate and run LDTs developed to suit specific clinical needs, and can help manufacturers optimize LDT performance in line with requirements for submission to regulators.

Discuss Your LDT with Us

BioAgilytix Diagnostics Test Menu

Explore the full library of diagnostic tests we offer today. For most tests, results are available within days of sample receipt.

Asterisk (*) denotes New York State approval.
Double asterisk (**) denotes New York State approval under executive order.

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COVID-19 PCR Testing

COVID-19 Fact Sheet for Healthcare Providers, TaqPath™ COVID-19 Combo Kit


COVID-19 Fact Sheet for Patients, TaqPath™ COVID-19 Combo Kit


COVID-19 Serology Testing

COVID-19 Fact Sheet for Healthcare Providers, Elecsys Anti-SARS-CoV-2 – Roche Diagnostics


COVID-19 Fact Sheet for Recipients, Elecsys Anti-SARS-CoV-2 – Roche Diagnostics



A Certified & Trusted Diagnostic Testing Partner

BioAgilytix Diagnostics’ facility is housed within BioAgilytix’s CLIA-certified and CAP-accredited laboratory in Boston, MA. Our extensive certifications enable us to accept samples from any US state, and we employ a seasoned Quality Assurance team to monitor every testing project from sample receipt to results reporting.

Registration & Certifications
State Licenses

Tested to the Highest Standards

As a seasoned diagnostic laboratory partner, we’ve demonstrated our ability to deliver the reliable results reference labs need, when and how they require them. We do so by adhering to proven quality processes and a service methodology that gives you the flexibility to customize how you engage with us – tailoring how your diagnostic testing is performed.

Tell us more about your biomedical testing requirements today to learn how we can help.

Call: 1.617.456.0800 | Email: [email protected]