The present invention relates to a method of creating a biomarker profile, the method comprising the steps of: obtaining a sample of biofluid from a subject, wherein the sample is stored on a sample collection apparatus; removing the sample from the sample collection apparatus; extracting nucleic acids from the sample; sequencing the extracted nucleic acids to generate sequence data; and analyzing the sequence data using a two-step analytical methodology to create the biomarker profile. The present invention is also directed to methods of determining the sex of an in utero fetus, predicting onset of a migraine in a subject, and of tracking athletic performance in a subject.

The present invention relates to a method of creating a biomarker profile, the method comprising the steps of: obtaining a sample of biofluid from a subject, wherein the sample is stored on a sample collection apparatus; removing the sample from the sample collection apparatus; extracting nucleic acids from the sample; sequencing the extracted nucleic acids to generate sequence data; and analyzing the sequence data using a two-step analytical methodology to create the biomarker profile. The present invention is also directed to methods of determining the sex of an in utero fetus, predicting onset of a migraine in a subject, and of tracking athletic performance in a subject.

The present invention relates to a method of creating a biomarker profile, the method comprising the steps of: obtaining a sample of biofluid from a subject, wherein the sample is stored on a sample collection apparatus; removing the sample from the sample collection apparatus; extracting nucleic acids from the sample; sequencing the extracted nucleic acids to generate sequence data; and analyzing the sequence data using a two-step analytical methodology to create the biomarker profile. The present invention is also directed to methods of determining the sex of an in utero fetus, predicting onset of a migraine in a subject, and of tracking athletic performance in a subject.

The present disclosure relates to methods for non-invasive prenatal testing (NIPT) using semm from a maternal blood sample taken during pregnancy. The methods provide efficient access to genetic information about the fetus, including gender, fetal DNA fraction, paternity, and possible genetic abnormalities. This approach is referred to herein as Afisawa, and makes NIPT genetic testing more efficient and cost effective than previous methods.

The present disclosure relates to methods for non-invasive prenatal testing (NIPT) using semm from a maternal blood sample taken during pregnancy. The methods provide efficient access to genetic information about the fetus, including gender, fetal DNA fraction, paternity, and possible genetic abnormalities. This approach is referred to herein as Afisawa, and makes NIPT genetic testing more efficient and cost effective than previous methods.

Systems and methods for provenance tracking and/or identification of a product using genetic material are claimed. In various embodiments, genetic material such as plasmids may be incorporated into and/or otherwise persistently associated with a product. The genetic material may be encoded with, among other things, information that may uniquely identify the product, provide details relating to the origins of the product, the handling, distribution, and/or chain of custody of the product, intellectual property rights and/or other rights associated with the product, and/or the like. By extracting and analyzing the genetic material from the product, information encoded in the genetic material may be obtained by an interested party.

Systems and methods for provenance tracking and/or identification of a product using genetic material are claimed. In various embodiments, genetic material such as plasmids may be incorporated into and/or otherwise persistently associated with a product. The genetic material may be encoded with, among other things, information that may uniquely identify the product, provide details relating to the origins of the product, the handling, distribution, and/or chain of custody of the product, intellectual property rights and/or other rights associated with the product, and/or the like. By extracting and analyzing the genetic material from the product, information encoded in the genetic material may be obtained by an interested party.

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.

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.

Technologies for assessing, quantifying and isolating sperm cell populations and/or subpopulations having specific genetic signatures are provided, as well as methods and systems to assess the efficacy of chromosomal differentiation processes. Compositions for identification and differentiation of X-chromosomes and Y-chromosomes in DNA are also provided.