A method of providing a diagnosis for a subject having Cowden-like syndrome or PTEN germline mutations is described. The method includes the steps of: (a) obtaining a biological sample from a subject; (b) conducting a germline PTEN mutation and deletion analysis of genomic DNA from the biological sample; (c) determining the level of copy number variation in the genomic DNA; (d) comparing the level of copy number variation in the genomic DNA to a control value for copy number variation; and (e) diagnosing the subject as having an increased risk of developing a neurodevelopmental disorder if the copy number variation level is higher than the control value.

Provided herein are methods of determining a location of one or more analytes of interest in a cancer sample. Also provided herein are methods of detecting expression of one or more analytes in a cancer (e.g., breast cancer) sample. Further provided are methods of diagnosing and treating breast cancer.

Methods of quantitating extra-cellular vesicle surface markers are provided. Aspects of the methods include comparing: a mean fluorescence intensity of a surface marker of interest (surface marker MFI) of a labeled extra-cellular vesicle (EV) sample with a calibration plot obtained from a liposome calibration composition to quantitate the surface marker on extra-cellular vesicles of the EV sample. Also provided are compositions that find use in practicing embodiments of the invention.

Aqueous calibration or quality control reagents that include urea are disclosed; the reagents may further include at least one amino acid-containing composition to provide pH stability thereto. Methods of production and use thereof are also disclosed.

The invention relates to methods for predicting the outcome of a patient suffering from prostate cancer or breast cancer and methods for the treatment of prostate cancer or breast cancer. The inventors show that Doublecortin-expressing (DCX.sup.+) neural precursors from the central nervous system (CNS) enter the bloodstream, infiltrate prostate tumours and metastasis and differentiate into neo-neurons that contribute to tumour development. In human primary prostate tumours and transgenic mouse cancer tissues, the density of DCX.sup.+ neural progenitors is strongly associated with tumour aggressiveness, invasion and recurrence. In transgenic cancer mice, oscillations of DCX.sup.+ neural stem cells in the subventricular zone (SVZ), a neurogenic area of the CNS, were associated with egress of DCX.sup.+ cells from the SVZ to the bloodstream. These cells then reach the tumour where they initiate neurogenesis. Selective genetic depletion of DCX.sup.+ cells in mice inhibits the early phases of prostate cancer development, whereas ortho topic transplantation of DCX.sup.+ cells purified from prostate tumour or brain tissues promotes tumour growth and cancer cell dissemination. These results unveil a unique crosstalk between the CNS and the tumour that drives a process of neurogenesis necessary for prostate cancer development, and indicate a novel neural element of the tumour microenvironment as a potential target for cancer treatment. Thus, the invention relates to a method for predicting the outcome of a patient suffering from prostate cancer and compound targeting DCX.sup.+ neural progenitor cells for use in the treatment of prostate cancer.

Aspects of the disclosure relate to liquid chromatography (e.g., HPLC) methods which enable high resolution separations of polynucleotides having hydrophobic portions (e.g., polyadenylated nucleic acids, such as mRNA) based upon the hydrophobic character of the molecules (e.g., polyA tail length). In some embodiments, the disclosure describes liquid chromatographic methods for separating a nucleic acid having a hydrophobic portion (e.g., a polyadenylated nucleic acid, such as an mRNA) from a complex mixture by a mobile phase system that comprises an ion pairing agent selected from Tris, inorganic cations (including e.g., Na, Li, K, ammonium, etc.), biological buffers (e.g., MOPS, HEPES, PIPES, etc.), and other charged or hydrophilic moieties, and lacks conventional ion pairing agents (e.g., Triethylammonium acetate, TEAA). Accordingly, in some embodiments methods described by the disclosure are useful for assessing the quality of pharmaceutical preparations comprising nucleic acids.

A method of calibrating a device for measuring the concentration of creatinine in a sample including one or more enzyme modulators, the device comprising an enzyme layer, the method comprising: determining sensitivities of the device for each of one or more calibration solutions; determining a degree of modulation for the sample to be measured, determining a degree of modulation for each calibration solution; wherein said determining of each of the degrees of modulation comprises estimating the concentration of an enzyme modulator in the enzyme layer of the device; and calculating the sensitivity of the device for the sample, wherein the said calculating comprises adjusting the sensitivity of the device for each calibration solution by a factor comprising the determined degrees of modulation of the sample and the calibration solution.

Reagents are disclosed for use with potentiometric magnesium ion selective electrodes, along with kits containing same as well as methods of use thereof.

Methods and kits for identifying an increased risk of developing preeclampsia in a pregnant woman based on expression pattern of non-coding RNAs in body fluids are provided. In particular, the methods provide information for identifying a pregnant woman as being at risk of developing preeclampsia by analyzing the pattern of non-coding RNAs in body fluids during early stages of pregnancy.

The present invention relates to a method for assessing whether a pregnant subject is at risk of developing preeclampsia or a preeclampsia-related condition, or not, said method comprising the steps of determining the amount of the biomarker IGFBP-7 (Insulin-like Growth Factor Binding Protein 7) in a sample from the subject, and comparing the determined amount of the biomarker to a reference. Further, the present invention relates to the in vitro use of the biomarker IGFBP-7, or of at least one detection agent which specifically binds to IGFBP-7 in a sample of a pregnant subject for assessing whether said subject is at risk of developing preeclampsia or a preeclampsia-related condition, or not. Also encompassed by the present invention is a device adapted to carry out the method of the present invention.