# US 10,865,447 B2 · Biomarker signature method, and apparatus and kits therefor

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- Number: US 10,865,447 B2
- Document ID: US10865447B2
- Status: Granted
- Kind: B2
- Application number: 14/714,188
- Filed: 2015-05-15
- Published: 2015-09-17
- Granted: 2020-12-15
- Earliest claimed: 2014-02-06
- Assignees: Immunexpress Pty Ltd
- Applicants: ImmuneXpress Pty Ltd
- Inventors: Richard Bruce Brandon; Leo Charles McHugh
- Web page: https://patentgrep.com/patent/US10865447B2

## CPC

- C12Q 1/6883: for diseases caused by alterations of genetic material
- A61P 31/04: Antibacterial agents
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G16B 25/00: ICT specially adapted for hybridisation; ICT specially adapted for gene or protein expression
- G16B 25/10: Gene or protein expression profiling; Expression-ratio estimation or normalisation
- G16B 25/20: Polymerase chain reaction [PCR]; Primer or probe design; Probe optimisation
- C12Q 2600/118: Prognosis of disease development
- C12Q 2600/16: Primer sets for multiplex assays
- G16B 40/00: ICT specially adapted for biostatistics; ICT specially adapted for bioinformatics-related machine learning or data mining, e.g. knowledge discovery or pattern finding
- C12Q: MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS (immunoassay G01N33/53); COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- G16B: BIOINFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR GENETIC OR PROTEIN-RELATED DATA PROCESSING IN COMPUTATIONAL MOLECULAR BIOLOGY

## Abstract

The present invention discloses methods, kits, and apparatus as well as reagents and compositions associated therewith for deriving an indicator for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. Also disclosed is a biomarker signature for use in diagnosing the presence, absence or degree of at least one condition in a biological subject or in prognosing at least one condition in a biological subject. The present invention further discloses methods, kits and apparatus, as well as reagents and compositions associated therewith, for identifying biomarkers for use in a biomarker signature.

## Claims

### Claim 1

A composition comprising a mixture of a DNA polymerase, whole peripheral blood leukocyte cDNA from a subject with a clinical sign of systemic inflammatory response syndrome (SIRS), wherein the whole peripheral blood leukocyte cDNA comprises a basic leucine zipper transcription factor (BATF) cDNA and a retinitis pigmentosa GTPase regulator interacting protein 1 (RPGRIP1) cDNA and the composition further comprises for each of up to 6 cDNAs, which comprise the BATF cDNA and RPGRIP1 cDNA, (1) two oligonucleotide primers that hybridize to opposite complementary strands of the cDNA, and (2) an oligonucleotide probe that comprises a reporter molecule and that hybridizes to the cDNA, wherein the oligonucleotide probe is a real-time polymerase chain reaction probe.