Abstract: Disclosed are controls and reference materials for use in identifying any of a number of genotypes and/or for use in identifying or characterizing a disease or condition. The controls and reference materials may be particularly useful for diagnostic tests that utilize circulating cell-free DNA (cfDNA). Also disclosed herein are methods of generating large quantities of cfDNA that preserve the original cfDNA size and input sequences. In some embodiments, the methods comprise amplifying, digesting, and purifying cfDNA isolated from a subject. The cfDNA may be circulating tumor DNA (“ctDNA). The methods disclosed herein result in a cfDNA or ctDNA clone library that is significantly more “commutable” compared to existing methods.

Abstract: Disclosed are controls for use in identifying any of a number of genotypes and/or for use in identifying or characterizing a disease or condition. The controls may be particularly useful for diagnostic tests that utilize circulating cell-free DNA or microRNA. A control may comprise a mixture of nucleic acids. In some embodiments, a control comprises liposomes, e.g., wherein nucleic acids of the control are associated with the liposomes. For example, the controls are useful for determining whether a fetus comprises an aneuploidy. Also disclosed are methods of using the controls.

Abstract: Disclosed are controls for use in identifying any of a number of genotypes and/or for use in identifying or characterizing a disease or condition. The controls may be particularly useful for diagnostic tests that utilize circulating cell-free DNA or microRNA. A control may comprise a mixture of nucleic acids. In some embodiments, a control comprises liposomes, e.g., wherein nucleic acids of the control are associated with the liposomes. For example, the controls are useful for determining whether a fetus comprises an aneuploidy. Also disclosed are methods of using the controls.

Abstract: Disclosed are controls for use in identifying any of a number of genotypes and/or for use in identifying or characterizing a disease or condition. The controls may be particularly useful for diagnostic tests that utilize circulating cell-free DNA or microRNA. A control may comprise a mixture of nucleic acids. In some embodiments, a control comprises liposomes, e.g., wherein nucleic acids of the control are associated with the liposomes. For example, the controls are useful for determining whether a fetus comprises an aneuploidy. Also disclosed are methods of using the controls.

Abstract: Disclosed are controls and reference materials for use in identifying any of a number of genotypes and/or for use in identifying or characterizing a disease or condition. The controls and reference materials may be particularly useful for diagnostic tests that utilize circulating cell-free DNA (cfDNA). Also disclosed herein are methods of generating large quantities of cfDNA that preserve the original cfDNA size and input sequences. In some embodiments, the methods comprise amplifying, digesting, and purifying cfDNA isolated from a subject. The cfDNA may be circulating tumor DNA (“ctDNA). The methods disclosed herein result in a cfDNA or ctDNA clone library that is significantly more “commutable” compared to existing methods.