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.
We’re ready to help. Call 1.617.456.0800 or complete the Test Request form.
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.
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.
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.
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.
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.
Asterisk (*) denotes New York State approval.
Double asterisk (**) denotes New York State approval under executive order.
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.
FDA Registration | CLIA Certification | CAP Accreditation
California | Maryland | Massachusetts | New York | Pennsylvania | Rhode Island
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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