The present invention provides biomarkers allowing the diagnosis of symptomatic congenital cytomegalovirus (CMV) infection and in particular to differentiate between symptomatic and asymptomatic infected fetuses, methods of diagnosis of CMV using said biomarkers, diagnostic kits comprising thereof, and use of the kits and methods of diagnosing fetuses infected with a symptomatic congenital cytomegalovirus (CMV).

Novel compositions, methods, assays and kits directed to a diagnostic panel for Alzheimer's disease are provided. In one embodiment, the diagnostic panel includes one or more proteins associated with Alzheimer's disease.

Methods and compositions for risk detection, early diagnosis, prognosis, and monitoring of sleepiness in an individual by measuring the amount of specific biomarkers present in a bodily fluid and comparing them to a reference level of biomarkers in a sample from a healthy person, a person previously diagnosed with sleepiness, or an earlier sample from the individual of interest.

This invention relates methods and compositions for identifying Colorectal Cancer (CRC) prognostic transcripts and groups of CRC prognostic transcripts useful in determining the prognosis of cancer in a patient, particularly for gastrointestinal cancer, such as gastric or colorectal cancer. Specifically, this invention relates to CRC cell culture-based methods to identify cell proliferation signatures.

In certain embodiments, the present invention provides a method of treating or preventing lupus (e.g., SLE) in a subject, comprising: (a) identifying the subject as having at least one differentially regulated biomarker selected from CD40, CD40L, CD86, CD80, and PD1; and (b) administering an agent that inhibits the CD40 or CD28 signaling pathway, thereby treating or preventing lupus in the subject. In other embodiments, the present invention provides a method of treating or preventing lupus (e.g., SLE) in a subject, comprising: (a) administering an agent that inhibits the CD40 or CD28 signaling pathway; (b) determining whether the agent neutralizes at least one differentially regulated biomarker selected from CD40, CD40L, CD86, CD80, and PD1; and (c) adjusting the dosing of the agent in the subject, thereby treating or preventing lupus in the subject.

The present invention is directed to methods for detecting a melanoma, methods for determining whether a melanoma is stable or progressive, methods for evaluating the extent of surgery resection in a subject having a melanoma, and methods for determining a response by a subject having a melanoma to a therapy.

The present invention is directed to methods for detecting a plasma cell dyscrasia like myeloma or MGUS, methods for determining whether a plasma cell dyscrasiais stable or progressive, methods for determining a risk for disease relapse, and methods for determining a response by a subject having a plasma cell dyscrasia to a therapy.

The present disclosure pertains to predicting an onset of a cerebral hemorrhagic event in a subject by testing a blood sample of the subject for the presence or absence of one or more indicators; and correlating the presence or absence of the one or more indicators to the subjects risk for suffering from the cerebral hemorrhagic event, where the presence of the one or more indicators is correlated to an increased risk in the subject for suffering from the cerebral hemorrhagic event and where the absence of the one or more indicators is correlated to a decreased risk in the subject for suffering from the cerebral hemorrhagic event. The methods of the present disclosure may also include implementing a therapeutic decision in order to prevent the cerebral hemorrhagic event. The present disclosure also pertains to kits for use in predicting an onset of a cerebral hemorrhagic event in a subject.

Provided herein are methods and biomarkers useful for detecting and diagnosing osteoarthritis and predicting the progression of osteoarthritis in subjects. The diagnoses and predictions of prognosis may be used to develop treatment plans for subjects. Also included are methods of treating subjects and administering pharmaceuticals based on the diagnosis and prognosis predictions.

Methods and reagents for diagnosing, prognosing, and treating systemic lupus erythematosus (SLE) are disclosed, involving calculating an SLE risk score for a subject based on a level of each of an erythrocyte C4d (EC4d) marker, a B-cell C4d (BC4d) marker, anti-nuclear antibodies (ANA), and optional rule-out markers.