Development of reliable multiplex assays on xMAP beads for serological or other assays, is not only dependent on proper coupling of capture molecules, it is also dependent on the proper mixing of multiple bead regions into multiplex bead mixes.  

Several excel based workbooks are available to assist with insuring the most precise coupling of molecules using different ug/million beads or picomols/million beads coating levels.  These workbooks insure the accuracy of calculating the volumes of reagents needed at different concentrations to maintain the stoichiometry of all reagents even with scaling up.  In addition several excel based tools are available to precisely calculate how to make multiplex mixes for any assay configuration. 

Hematuria (blood in urine) may occur in up to 10% of the general population and results in costly evaluation to ensure it is of no consequence, i.e., no bladder cancer (BCa) is present since hematuria is typically the initial sign of BCa. Furthermore, 75% of patients with newly diagnosed BCa have non-muscle-invasive disease (NMIBC), which has a very high recurrence rate (>70%). Because of this, it is recommended that the patients have adjuvant intravesical bacillus Calmette-Guerin (BCG) instillation to reduce this risk. Despite BCG treatment, up to 50% of patients fail to respond and 20% progress to muscle invasive bladder cancer (MIBC) mandating more radical treatment (i.e., cystectomy - removal of the urinary bladder). Moreover, the delay in radical treatment can negatively impact survival rates, hence, a test that could predict treatment response to intravesical BCG, ensuring the right patient, gets the right treatment at the right time is urgently required. To date, no such test is available. Our group has developed and tested a multiplex immunoassay towards a BCa signature with extremely encouraging results in subjects evaluated for hematuria and in subjects destined to be treated with BCG. This research will open the door for improving on the non-invasive methods for detecting BCa and predicting treatment response as such it will have a marked impact on patient care.  

Stroke is among the most common neurologic disorders and a leading cause of death anddisability worldwide. Among the most long-lasting consequences of stroke and cerebrovasculardisease is cognitive impairment and dementia which is common even after small strokes.Diagnostically, stroke and the individual risk for cerebrovascular disease is difficult to measurewith post-stroke imaging being the most common diagnostic risk assessment. SageCerebrovascular Diagnostics is partnering with Luminex to develop a multiplex immunoassayusing serum and plasma samples that can measure brain vascular injury. In published data, this6-plex immunoassay that measures circulating levels of inflammatory molecules centered on thepleotrophic cytokine IL-18, strongly correlates with MRI measures of chronic cerebrovasculardisease that increase the risk of stroke and dementia. By providing a simple and reproduciblemeasure of cerebrovascular injury in the blood stream, Sage will deliver a new diagnostic toolfor patients and providers to help modify and reduce the risk of stroke and long-termconsequences.

Cytokines can be thought of as the hormones of the immune system.  They are small proteins which play an integral role in cell signaling with key roles in host immune responses to infection, inflammation, trauma, sepsis, cancer, and reproduction.  Cytokine testing is primarily used for research and to support attempts to understand the pathogenesis of immune, infectious, allergic, or inflammatory disorders.  Clinical testing for cytokines, for the most part, has no established diagnostic utility for any particular disease or illness.  It is, however, gaining greater clinical utility for monitoring cytokine and immunomodulating therapies, safety monitoring of clinical trials and cytokine storm syndrome.  There are currently no FDA-cleared invitro diagnostic tests approved for cytokine testing, requiring stringent validation by reference laboratories in order to offer cytokine testing in the clinical setting.  Research use only or laboratory developed tests should therefore be thoroughly validated following Clinical and Laboratory Standards Institute (CSLI) guidelines for accuracy, precision, linearity, detection capability, interfering substances, analyte stability and establishing specimen type specific reference intervals. 

Blockade of checkpoint receptors with monoclonal antibodies have shown great clinical success, but some patients develop resistance and remain refractory. Both PD-1/PD-L1 and HER-2 inhibitors have limited efficacy and toxicities. Ongoing clinical studies support the need for combination immuno-oncology agents to save the lives of patients. We introduce a novel PD-L1 B-cell peptide vaccine linked to a “promiscuous” T cell MVF peptide (PDL1-Vaxx) or linked to TT3 via a linker. These vaccines are highly immunogenic and antigenic in animal models. The PD-L1 vaccines elicited high titers of antibodies that inhibit tumor growth, induced PD-1/PD-L1 blockade, decreased proliferation, induced apoptosis and caused ADCC of tumor cells. The combination of PDL1-Vaxx with HER-2 vaccine (B-Vaxx) demonstrated tumor inhibition in D2F2/E2 carcinoma. The anti-PDL1-Vaxx block PD-1/PD-L1 interaction and significantly prolonged anti-tumor responses. The combination of B-Vaxx with either PDL1-Vaxx or PD1-Vaxx demonstrated tumor inhibition. PDL1-Vaxx is a promising safe checkpoint inhibitor vaccine. 

xMAP Technology has been a tried and true platform for biological research and discovery for 27 years. From humble beginnings as a novel multiplexing technology, it has become the worldwide leader for bead-based multiplexed analysis and an indispensable tool in the toolbox of research and clinical laboratories across the globe. As of June 2022, over 60,000 peer-reviewed publications have been reported by investigators who use xMAP Technology in their work. This session will review some recent xMAP literature that highlight the versatility and flexibility of this innovative platform. We will discuss a variety of topics that all have one thing in common – xMAP Technology. Join us as we discuss some of the newest publications on biomarker research in cancer chemotherapy, autism, gut microbiome, and obesity, as well as studies on infectious diseases, including dengue fever, tuberculosis, HIV, and COVID-19.