Biomarker signature method, and apparatus and kits therefor
Inventors
Brandon, Richard Bruce • MCHUGH, Leo Charles
Assignees
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Publication Number
US-10865447-B2
Publication Date
2020-12-15
Expiration Date
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.
Core Innovation
The disclosure relates to biomarker signature methods, apparatus, and kits for diagnosing and prognosing immune-system mediated conditions using immune system biomarker values. The biomarker signature uses one or more immune biomarker values whose derived values are ratios of concentrations, where the concentrations are obtained from polynucleotide expression products.
The derived biomarker values are combined to compute an indicator and biomarker signature that is compared to stored indicator references or distributions to yield likelihood or probability. In the biomarker signature, the polynucleotide expression products can be reverse transcribed mRNAs from leukocytes, including peripheral blood leukocytes.
The invention relates to systemic inflammatory response syndrome (SIRS) biomarker measurement, interpretation, and use for diagnosis, prognosis, and treatment monitoring across clinical states including inSIRS, ipSIRS/sepsis, and stages such as mild, moderate, and severe systemic inflammatory response syndrome and septic shock. It defines measuring multiple immune system biomarkers by obtaining biomarker values from a subject and using those values to compute an indicator/biomarker signature.
The disclosure also includes an IRS biomarker gene set and downstream kit/assay concepts, including real-time polymerase chain reaction probe relevance with a reporter molecule and whole peripheral blood leukocyte (PBL) cDNA as an assay input. BATF cDNA and RPGRIP1 cDNA are included as part of the composition and measurement approach, as supported by the described gene set and assay components.
Claims Coverage
The provided material includes independent claim coverage centered on a composition for real-time polymerase chain reaction measurement of whole peripheral blood leukocyte cDNA associated with systemic inflammatory response syndrome (SIRS), using BATF cDNA and RPGRIP1 cDNA with primers and reporter probe components.
Real-time PCR composition with SIRS whole peripheral blood leukocyte cDNA
A composition comprising a mixture of a DNA polymerase and whole peripheral blood leukocyte (PBL) cDNA from a subject with a clinical sign of systemic inflammatory response syndrome (SIRS), wherein the whole peripheral blood leukocyte cDNA comprises BATF cDNA and RPGRIP1 cDNA.
Paired primers and reporter probe for each cDNA up to six
For each of up to 6 cDNAs comprising the BATF cDNA and RPGRIP1 cDNA, the composition includes two oligonucleotide primers that hybridize to opposite complementary strands of the cDNA and an oligonucleotide probe comprising a reporter molecule that hybridizes to the cDNA, wherein the oligonucleotide probe is a real-time polymerase chain reaction probe.
The claim coverage focuses on a DNA polymerase composition using whole peripheral blood leukocyte cDNA from an SIRS subject that includes BATF cDNA and RPGRIP1 cDNA, together with up to 6 cDNA-specific primer sets and reporter-containing real-time PCR probes.
Stated Advantages
Supports diagnosis and prognosis for systemic inflammatory response syndrome states including inSIRS, ipSIRS/sepsis, and septic shock.
Enables treatment efficacy monitoring by comparing pre-treatment and post-treatment indicator outcomes and classifying treatment response as effective or not effective.
Correlates biomarker signatures with positive response, negative response, and side effects.
Documented Applications
Diagnosis, prognosis, and treatment monitoring for systemic inflammatory response syndrome, including inSIRS and ipSIRS/sepsis, across stages such as mild/moderate/severe and septic shock.
Monitoring treatment regimen efficacy by assessing response based on biomarker indicator outcomes and correlating biomarker signatures with positive/negative response and side effects.
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