Provided herein are methods of detecting pathogen antibodies, such as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), in samples. Related devices, kits, reaction mixtures, and systems are also provided.

Provided herein are methods of detecting a pathogen, such as a severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), in aerosol samples. Related devices, kits, systems, and computer program products are also provided.

The invention, in part, includes methods of single molecule protein sequencing that include using weak binding spectra in the amino acid identification.

The present disclosure relates to prostate specific membrane antigen (PSMA) targeted compounds conjugated to near-infra red (NIR) dyes and methods for their therapeutic and diagnostic use. More specifically, this disclosure provides compounds and methods for diagnosing and treating diseases associated with cells and/or vasculature expressing prostate specific membrane antigen (PSMA), such as prostate cancer and related diseases. The disclosure further describes methods and compositions for making and using the compounds, methods incorporating the compounds, and kits incorporating the compounds.

The present disclosure describes a biomarker for predicting a response to an anticancer agent for immunotherapy, and more particularly, to a marker composition for predicting a response to a programmed cell death protein 1 (PD-1) inhibitor, pembrolizumab, which includes one or more genes selected from the group consisting of armadillo repeat-containing X-linked protein 1 (ARMCX1; NCBI accession number: NM_016608), serine/threonine-protein kinase D1 (PRKD1; NCBI accession number: NM_002742) and tyrosine kinase 2 (TYK2; NCBI accession number: NM_003331) or a protein encoded by the gene, and a composition, kit and information providing method for predicting a response to an anticancer agent. Since the gene marker according to the present disclosure utilizes a formalin-fixed paraffin-embedded tissue derived from a patient for analysis, separate sampling is not needed, and thus analysis is convenient.

Methods for identifying a binding site between a protein pharmaceutical product and a host-cell protein (HCP) using hydrogen exchange mass spectrometry are provided. The present application also provides methods to modify protein pharmaceutical products to eliminate the cleavage or modification by HCPs. In addition, the present application provides methods to block the identified binding site in protein pharmaceutical products to eliminate the cleavage or modification by HCPs.

The present disclosure relates to methods, compositions, and systems for detecting whether a subject exposed to a coronavirus has developed a neutralizing antibody response. Also disclosed are methods for determining whether a patient infected by a coronavirus is likely to respond to treatment with an antibody preparation. Also disclosed are methods for detecting the level of neutralizing antibody response in a sample of serum from a subject exposed to a coronavirus or to a coronavirus vaccine.

The present disclosure an ELISA-based assay that uses a glycosylated polypeptide fragment derived from the SARS-CoV-2 spike protein (Covid-19) receptor binding domain (S1RBD) that has affinity for the extracellular domain of Angiotensin Converting Enzyme 2 (ACE2). The S1RBD polypeptide is generated by expression of an encoding nucleic acid by a human cell expression system resulting in glycosylation of the expressed spike receptor binding domain (S1RBD) protein at least at the N343 N-glycosylation site thereof, and which surprisingly and significantly increases the affinity of the S1RBD for ACE2, provides a significant increase in the sensitivity of the assay compared to other known assays.

The present invention relates to the development of novel immunoassays for the detection of neutralizing antibodies and/or high avidity neutralizing antibodies to SARS-CoV-2 spike protein variants or fragments thereof and, optionally, one or more cytokine in patient samples. Novel multiplex and singleplex immunoassays for the detection of neutralizing antibodies and/or high avidity neutralizing antibodies to SARS-CoV-2 spike protein variants or fragments thereof and, optionally, one or more cytokine in patient samples are also provided.

Provided herein are methods, systems and kits for use in identifying a subject with an increased risk of developing severe forms of inflammatory bowel disease (IBD), based at least in part, on an expression of one or more biomarkers detected in a biological sample obtained from the subject. Also provided are methods, systems and kits for treating, or optimizing the treatment for, the IBD based, at least in part, on the expression the one or more biomarkers. In some embodiments, the one or more biomarkers is angiotensin-converting enzyme 2 (ACE2), the host receptor for severe acute respiratory syndrome (SARS) coronavirus 2 (SARS-CoV-2).