A direct chemical lysis composition includes an assay compatible buffer composition and an assay compatible surfactant. When combined with a specimen storage composition, such compositions prevent undesired modifications to nucleic acid and proteins lysed from cells in the biological sample. Assays of samples from such compositions do not require expensive and time-consuming steps such as centrifugation and prolonged high temperature processing. The direct chemical lysis composition of the present invention permits direct nucleic acid extraction from the cells in the biological sample without the need to decant off the transport media or otherwise exchange the transport media with assay compatible buffers. There is no need to combine the sample with proteinase K or another enzyme to extract nucleic acids from the cells. A method for lysing cells to obtain target nucleic acid for assay and a kit for combining the direct chemical lysis composition with a sample are also contemplated.

A method is described for differentiating in a subject with HPV16 between (i) a severe form of HPV16 infection and (ii) a mild form of HPV16 infection based on determining the amount of a first gene product and a second gene product in a sample of a subject and calculating a ratio of the amount of the first gene product and the amount of the second gene product. A composition is also described, including an oligonucleotide mixture, and also a kit and a device adapted to carry out the described method.

A method is described for differentiating in a subject with HPV16 between (i) a severe form of HPV16 infection and (ii) a mild form of HPV16 infection based on determining the amount of a first gene product and a second gene product in a sample of a subject and calculating a ratio of the amount of the first gene product and the amount of the second gene product. A composition is also described, including an oligonucleotide mixture, and also a kit and a device adapted to carry out the described method.

The present invention relates to primers, probes, primer sets, primer and probe sets, methods and kits for detecting human papillomaviruses, human beta globin sequences and human papillomaviruses and human beta globin sequences in a test sample.

Cervical cancer cells and HPV.sup.+ head and neck cancer cells express three testis-specific genes not normally expressed in somatic cells: testicular cell adhesion molecule 1 (TCAM1), synaptonemal complex protein 2 (SYCP2) and stromal antigen 3 (STAG3). Among the three markers, TCAM1 and SYCP2 are early detection markers. Various methods for identifying a human or non-human animal as a candidate for further examination for cervical cancer, preneoplastic lesion for cervical cancer, head and neck cancer, or preneoplastic lesion for head and neck cancer are disclosed. Methods of detecting said cancers and preneoplastic lesions, methods of screening for drugs for treating said cancers and preneoplastic lesions, methods for monitoring the effectiveness of a treatment for said cancers, and methods of treating said cancers are also disclosed. Further disclosed are kits that can be used to practice the above methods.

The present disclosure provides methods and compositions of modified oligonucleotide primer and probe combinations, structurally modified with locked nucleic acids, quenchers, and dyes, effective to detect tumor-derived Human Papilloma Virus (HPV) and tumor-derived Epstein-Barr virus (EBV) and, especially, to distinguish viral DNA derived from tumors from viral DNA derived from infectious viral particles.

Disclosed is a diagnostic panel of methylated genomic loci encoding microRNA (mgmiR) markers that demonstrated 90% sensitivity and 100% specificity in the detection of head and neck squamous cell carcinoma (HNSCC). These results represent the first use of quantitative MS-PCR for the detection of mgmiRs. In addition this panel demonstrates the ability to detect hypermethylation in the adjacent mucosa of cancer patients, suggesting its utility in early detection. This panel is also capable of detecting cancer by using saliva, blood and FNA tissue samples.

The invention relates to methods, reagents and kits for detecting the susceptibility to cervical cancer. In particular, it relates to novel methylation markers to improve screening for cervical intraepithelial neoplasia grade 2/3 (CIN2/3) and the use thereof for identifying a cervical cell as neoplastic or predisposed to neoplasia in an isolated sample.

Disclosed is a process for retrieval of nucleotide sequence. The process includes mixing iron chloride tetrahydrate with iron (III) chloride hexahydrate in solution; adding ammonium hydroxide to the mixture and stirring to form maghemite nanoparticles; stirring the maghemite nanoparticles in a solution with an inorganic acid, a surfactant and a monomer precursor of a conducting polymer; initiating polymerization of the monomer by adding the inorganic acid and an oxidizing agent to the stirred solution and further stirring to yield Polyaniline/maghemite nanocomposites; adding the nanocomposites to an first aqueous solution of the nucleotide sequence and stirring so as to electrostatically interact the nanocomposites with the nucleotide sequence; and weakening the electrostatic interaction between the nanocomposite and the nucleotide sequence to recover the nanocomposite independently of the nucleotide sequence.

The invention involves methods for identification of biomarkers of the severity of an HPV infection.