The invention generally relates to antibodies that bind to human folate receptor and diagnostic assays for folate receptor 1-based therapies. Methods of using the antibodies to monitor therapy are further provided.

The capabilities of using gold nanoparticle as surface-enhanced Raman scattering (SERS) substrate to obtain cervical smear harvested cells biochemical information for non-invasive cervical precancerous detection were presented in this patent document. A SERS reagent and a platform has been developed and optimized for the generation of a differential spectral fingerprinting for cervical cancer detection. SERS measurements were performed on three group's cervical exfoliated cell samples: one group from patients (n=36) with pathologically confirmed cervical cancer and another group with high-grade squamous intraepithelial lesion (HSIL) (n=41) and the last group from healthy volunteers (control subjects, n=47). Tentative assignments of the Raman bands in the measured SERS spectra suggested interesting cancer specific biomolecular changes, including an increase in the relative amounts of amino acids, nucleic acid, carotenoid contents in the cell samples of cervical cancer patients as compared to that of healthy subjects. The results from this study demonstrated that gold nanoparticle based SERS substrate harvested exfoliated cervical smear cell analysis has tremendous potential for the non-invasive detection of cervical precancerous lesions.

A pharmaceutical composition is for prophylaxis and/or treatment of an infection of the cervix with human papillomavirus (HPV). A method carried out ex vivo is for predicting the probability of cure of HPV infection of the cervix. A biomarker is for predicting the emergence and/or development of cervical in-traepithelial neoplasia and/or cervical carcinoma and the likelihood of cure of cervical infection with HPV. Another method is for prophylaxis and/or treatment of cervical infection with HPV.

Devices, systems, and methods are provided for magnetic focus enhanced lateral flow assays. The devices and systems are ultrasensitive and provide for the visual detection of the presence or absence of one or more target analytes—which may include pathogens, proteins, or even molecules smaller than the foregoing—even when such analytes are only present in very limited amounts. The devices and systems include an immunostrip with a magnet positioned adjacent thereto, and magnetic probes specific to a target analyte that bind to the target analyte with specificity if present within a fluid sample to be tested. Methods are also provided for detecting one or more target analytes using magnetic focus, such methods including a step of controlling movement of a target analyte complex on an immunostrip incorporating a magnetic field, where such control slows a flow of the target analyte complex through a capture area on the immunostrip.

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.

The present invention relates to a method for the production of a cervix epithelial cell organoid culture. By means of this method, an organoid culture of cervix epithelial cells, and a biobank comprising a plurality of different organoid cultures thereof may be generated. Further, a culture medium suitable for the long-term culture of epithelial stem cells is provided. Furthermore, the use of the organoid culture in the biobank for medical applications, e.g. in the field of diagnostics and therapy and in the fields of drug screening and immunotherapy is described.

Disclosed herein a female hygienic device for diagnosing and/or monitoring cancer, comprising at least one absorption zone for accumulating vaginal discharge; and at least one indication zone comprising at least one agent for visually reacting with a physiological marker, the physiologic marker is indicative of a cancerous condition.

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 is related to diagnostic tests or rapid detections of different types of cancer, especially cervical cancer and precancerous lesions. Especially, the invention relates to specific and useful protein biomarkers for the detection of said diseases, and to the methods for determination and detection of said biomarkers.

The present invention is related to diagnostic tests or rapid detections of different types of cancer, especially cervical cancer and precancerous lesions. Especially, the invention relates to specific and useful protein biomarkers for the detection of said diseases, and to the methods for determination and detection of said biomarkers.