Devices and methods described herein provide improved methods of screening for cervical disease. In certain embodiments, a sample transfer and preparation vial is provided, enabling self-collection and pre-processing of cervical samples to expedite sample processing and eliminate the need for a patient to travel to a medical facility for screening. In certain embodiments, an analysis cartridge having a multiplexed biomarker panel and an immunoassay-based analyzer are provided for sample analysis. The multiplexed biomarker panel provides high sensitivity and specificity to enable effective screening with a single procedure and thus, eliminates the need for multiple tests. In certain embodiments, a method of screening for cervical disease is provided, utilizing the aforementioned multiplexed biomarker panel. The method includes detecting levels of at least two biomarkers in a cervical sample, wherein one of the biomarkers is an oncoprotein from a high-risk strain of human papilloma virus (HPV) and another is a cellular protein.

Disclosed herein are antibodies having binding specificity to the amino acid sequences Ala Ser Ser Gly Leu Thr Val Glu Val Asp (SEQ ID NO:1) and Thr Val Glu Val Asp (SEQ ID NO:14), and methods of detecting cell death in a sample, comprising contacting the sample with a first antibody specific for a C-terminal amino acid sequence Ala Ser Ser Gly Leu Thr Val Glu Val Asp (SEQ ID NO:1) or Thr Val Glu Val Asp (SEQ ID NO:14) of a CK18 protein fragment having a C-terminal amino acid sequence of Val Glu Val Asp (SEQ ID NO:2) and a second antibody that specifically binds an epitope that is present in both full-length CK18 and the CK18 protein fragment, and that does not overlap with SEQ ID NO:1 or SEQ ID NO:14, under conditions such that the CK18 protein fragment present in the sample specifically binds to the first antibody and the second antibody, wherein one of the antibodies is bound to a solid support and the other antibody is bound to a detection moiety capable of producing a signal; optionally removing any unbound or excess material; and detecting the signal from the detection moiety, wherein the signal is positively correlated with the presence of the CK18 protein fragment in the sample.

Process for in vitro diagnosis and/or monitoring and/or prognosis and/or theranosis of hepatic disorders from a biological sample originating from a subject, in which process the presence and/or the concentration of the marker ADH1B (SEQ ID NO.2) and/or the presence and/or the concentration of the combination of the markers ADH1B (SEQ ID NO.2) and ADH1A (SEQ ID NO.1) is determined.

Herein disclosed is a method for the normalization of an immunological test, characterized in that the presence of a comparable amount of cells is determined by a sandwich ELISA test in which the capture antibody includes at least one antibody that binds to at least one keratin selected from among keratin 4, 5, 6, 8, 10, 13 and 18 and the detection antibody includes at least one antibody that binds to the selected keratin.

The present invention provides compositions and methods for inhibiting intermediate filament tetramerization and formation.

The current disclosure provides methods for detecting and analyzing K17 expression in a bladder sample obtained from a subject. The current disclosure also pertains to methods and kits for identifying a mammalian subject with bladder cancer by detecting the expression of K17 in a sample. The present methods include both cell-based and cell-free methods for determining the level of keratin 17 in a sample obtained from the bladder of a subject.

The present invention relates to an in vitro method for assessing the risk of non-small cell lung carcinoma (NSCLC) disease progression for a subject classified to have stable disease under an ongoing NSCLC treatment regime. The method involves determining the level of CYFRA 21-1 and/or the level of CA 125 in a sample obtained from the subject; and comparing (i) the determined level of CYFRA 21-1 to a CYFRA 21-1 cut-off level, (ii) the determined level of CA 125 to a CA 125 cut-off level, or (iii) a score taking into account the determined level of CYFRA 21-1 and/or the determined level of CA 125 to a cut-off score. The method of the invention further allows for assessing whether the subject responds to the ongoing treatment and/or whether the treatment regime should be maintained or modified. The invention also provides for corresponding uses, computer-implemented methods and computer program products.

Techniques for identifying and enumerating candidate target cells within a biological fluid specimen are described. A digital image of the biological fluid specimen is received, and one or more candidate regions of pixels in the digital image are identified by identifying connected regions of pixels of a minimum intensity having a size between a minimum size and a maximum size and an aspect ratio that meets a threshold. For each candidate region of at least one of the one or more candidate region, whether the portion of the image corresponding to the candidate region includes more than a threshold number of intensity levels is determined. If the portion of the image corresponding to the candidate region includes more than the threshold number of intensity levels the portion of the image is continued to be treated as a candidate for classification.

The present disclosure relates to a method of identifying an individual having non-small cell lung carcinoma as to be treated by chemotherapy based on marker molecules cytokeratin-19 fragments (CYFRA 21-1) and carcinoembryonic antigen (CEA) as well as the use of the marker molecules for the identification of an individual to be treated by chemotherapy.

The present invention pertains to a new method for the diagnosis, prognosis, stratification and/or monitoring of a therapy, of cancer, preferably colorectal cancer (CRC), in a subject. The method is based on the determination of the level of a panel of least one, preferably 3, 4 and most preferably at least 5, protein biomarker selected from the group consisting of the protein biomarkers Amphiregulin (AREG), Carcinoembryonic antigen (CEA), Insulin like growth factor binding protein 2 (IGFBP2), Keratin, type I cytoskeletal 19 (KRT19), Mannan binding lectin serine protease 1 (MASP1), Osteopontin (OPN), Serum paraoxonase lactonase 3 (PON3) and Transferrin receptor protein 1 (TR), in the biological sample obtained from the subject. The new biomarker panel of the invention allows diagnosing and even stratifying various cancer diseases. Furthermore, provided are diagnostic kits for performing the non-invasive methods of the invention. Since the biomarker panel of the invention provides a statistically robust method independent of the protein detection technology used, and considering that the biomarker panel of the invention is detected in plasma samples of the subjects, the invention provides an early detection screening examination that may be applied to a larger population.