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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

Complete the Test Request form here.

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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.

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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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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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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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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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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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
FDA Registration  CLIA Certification  CAP Accreditation
State Licenses

California  Maryland  Massachusetts  New York  Pennsylvania  Rhode Island

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]

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    USA HQ

    2300 Englert Dr

    Durham, NC, 27713

    919-381-6097

    Fax 919-381-6099

    San Diego Laboratory

    9050 Camino Santa Fe

    San Diego, CA 92121

    858-652-4600

    Fax 858-652-4699

    Brisbane Laboratory

    37 Kent St, Woolloongabba

    Queensland, 4102, Australia

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    USA HQ

    2300 Englert Dr

    Durham, NC, 27713

    919-381-6097

    Fax 919-381-6099

    San Diego Laboratory

    9050 Camino Santa Fe

    San Diego, CA 92121

    858-652-4600

    Fax 858-652-4699

    Brisbane Laboratory

    37 Kent St,Woolloongabba

    Queensland, 4102, Australia

    Boston Laboratory

    1320 Soldiers Field Road

    Boston, MA, 02135

    617-456-0700

    Fax 617-456-0701

    Boston Laboratory

    1320 Soldiers Field Road

    Boston, MA, 02135

    617-456-0700

    Fax 617-456-0701

    European HQ

    Lademannbogen 10

    22339 Hamburg Germany

    +49 405267790

    Melbourne Laboratory

    85 Commercial Road, Melbourne

    Victoria, 3004, Australia

    +61 3 9282 2184

    Copyright © 2022 BioAgilytix Labs. All rights reserved.
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    European HQ

    Lademannbogen 10

    22339 Hamburg Germany

    +49 405267790

    Melbourne Laboratory

    85 Commercial Road, Melbourne

    Victoria, 3004, Australia

    +61 3 9282 2184

    Subscribe to Our Newsletter

    Copyright © 2022 BioAgilytix Labs.

    All rights reserved.