Diagnostic Testing

Specialized Diagnostic Testing To Meet Your Quality & Timeline Demands

When you need a dependable diagnostic testing laboratory partner who consistently delivers reliable testing results on time, choose BioAgilytix Diagnostics. If tailored testing and responsive service matter to you, BioAgilytix Diagnostics should be your provider of choice. 

hand and blood sample test tube in a machine

BioAgilytix Diagnostics – your certified and trusted diagnostic testing partner

BioAgilytix Diagnostics is a CLIA-certified, CAP-accredited laboratory within BioAgilytix’s Boston, MA laboratory. Our certifications enable us to accept diagnostic samples from any US state*, and we operate as both an outsourcing laboratory partner for major reference labs and as a diagnostic testing facility for clients requiring CLIA-certified testing within clinical trials. 

*Accepting samples from New York requires submission and approval of individual assays by the New York State Department of Health. See the BioAgilytix Diagnostics current test menu for assays already available for New York state patients.   

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Diagnostic specialty areas

We specialize in esoteric testing using both FDA-cleared/approved assays and laboratory-developed tests (LDTs) with a more than 20-year track record delivering diagnostic testing results for major US reference laboratories and biopharma clients. We’re ready to fulfill your diagnostic testing needs, whether routine or complex, using state-of-the-art technology run by an experienced diagnostic team. 

  • For pathogen detection and surveillance 
  • BioAgilytix Diagnostics’ real-time PCR system provides maximum multiplexing capabilities along with high detection sensitivity and specificity in testing for pathogens, such as HIV-2. 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. IgG, IgM, and IgA antibodies may be detected in serum, plasma, or cerebrospinal fluid (CSF), and semi-quantitative testing via titers can also provide an indication of the 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 may provide guidance for patient management once diagnosed. 
  • To test for the presence of IgG and IgM antibodies  
  • Due to BioAgilytix Diagnostics’ location in the Northeast, our laboratory is very experienced in testing for tick-borne infections, including Lyme disease (Borrelia burgdorferi) as well as arboviruses transmitted via a variety of blood-feeding arthropods. Testing can be performed in serum, plasma, or CSF. 

BioAgilytix Diagnostics offers validation and routine patient testing using LDTs developed to suit specific clinical needs and can help manufacturers optimize LDT performance in line with requirements for submission to regulators. 

Diagnostic specialty areas

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

Asterisk (*) is denoted by New York State approval.

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

Call: 1.617.456.0800 | Email: customerservices@bioagilytix.com