Biomedica Immunoassays

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osteomiR - microRNA Biomarkers

Determination of fracture risk independent of BMD. Simple and standardized miRNA analysis in serum and plasma.


Assay characteristics:

Cat.No.: TW-KT-011-OT
Method:RT-qPCR, relative quantification without standard curve
Kit content:miRCURY™ RNA extraction,
osteomiR panel, SYBR Green
Kit size:for 48 samples*
Sample type:Serum, plasma (EDTA)
Control:optional: reference serum available on request
Sample size:200 µl serum or plasma required
Incubation time: sample to data in 8 hours with 2 hours hands-on time
Result read-out:The osteomiR™ software uses a proprietary algorithm to convert the individual miRNA data into a single fracture-risk score for the diagnosis of osteoporosis

*): The standardized kit results in a specific osteomiR™ signature. 11 miRNAs will be analysed for each sample resulting in 528 data points in total.

LOD: 10 copies/µl (6 replicates, 95% positive detection); LLOQ: 35 copies/µl

Intra-assay (n=6) ≤ 20%, Inter-assay (n=3) ≤ 20%

Dilution linearity:
synthetic osteomiRs:
The mean dilution linearity of synthetic controls in human serum samples yields an R² of 0.99 over 6 logs (Cq-range from 20 to 35).

Species cross reactivity:
The sequence homology of osteomiRs in rats and mice is high, however, detection can only be guaranteed for 100% conserved sequences. The assay detects the following microRNAs in:
Rats: rno-miR-203a-3p, rno-miR-127-3p, rno-let-7b-5p, rno-miR-29b-3p, rno-miR-335, rno-miR23a-3p, rnomiR-451-5p
Mouse: mmu-miR-203-3p, mmu-miR-188-3p, mmu-miR-127-3p, mmu-let-7p-5p, mmu-miR-214-3p, mmu-miR-29b-3p, mmu-miR-335, mmu-miR-23a-3p, mmu-miR-451-5p

Upon request, customized-assays for complete coverage of rodent or primate osteomiRs can be designed.

Service analysis: we can measure for you. Click link to get your personal customized service quotation.

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Click link for:

osteomiR™ IFU, cat# TW-KT-011-OT

miRNA Analytical Service Quotation Form

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All osteomiRs have been carefully selected for this test kit based on a series of studies conducted in human patients with:

- postmenopausal (primary) osteoporosis
- idiopathic male and female osteoporosis
- type-2 diabetic osteopathy

Bone densitometry (DEXA) provides the criterion for diagnosis of osteoporosis, but is not sufficiently sensitive to identify patients at immediate fracture risk. In addition, patients of type-2 diabetic osteopathy exhibit elevated fracture risk in spite of elevated bone marrow density. 

The osteomiR microRNA signature is intended to assess the risk of a first fracture in female patients of postmenopausal osteoporosis and type-2 diabetes. This information enables timely interventions and can help to avoid fractures.

Studies identified a consistent regulation of osteomiRs due to osteoporosis.
Correct classification rates of > 90 % have been repeatedly observed (see data and publications).


Click links for:

osteomiR™ - microRNA biomarkers

TAmiRNA osteomiR™ - Product Folder

TAmiRNA Sample Testing - Service Folder

TAmiRNA osteomiR™ FAQs

TAmiRNA microRNA Services FAQs



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Cost-utility analysis of fracture risk assessment using microRNAs compared with standard tools and no monitoring in the Austrian female population
E. Walter, H. Dellago, J. Grillari, H.P. Dimai, M. Hackl
Bone, Volume 108, 2018, pages 44-54.
PMID: 29269173

Click link for: osteomiR™ key publications

Differentially circulating miRNAs after recent osteoporotic fractures can influence osteogenic differentiation.
Weilner S, Skalicky S, Salzer B, Keider V, Wagner M, Hildner F, Gabriel C, Dovjak P, Pietschmann P, Grillari-Voglauer R, Grillari J, Hackl M.
Bone 2015; 79: 43 –51.
PMID: 26026730

Secreted microvesicular miR-31 inhibits osteogenic differentiation of mesenchymal stem cells.Aging Cell 2016; 1–11.Circulating microRNAs as novel biomarkers for bone diseases–complex signatures for multifactorial diseases?Hackl M, Heilmeier U, Weilner S, Grillari J. Mol Cell Endocrinol 2015; 432: 83-95.Serum microRNAs are indicative of skeletal fractures in postmenopausal women with and without type-2 diabetes and influence osteogenic and adipogenic differentiation of adipose-tissue derived mesenchymal stem cells in vitro.J Bone Miner Res 2016 Jun 27.Circulating microRNA signatures in patients with idiopathic and postmenopausal osteoporosis and fragility fractures. J Clin Endocrinol Metab. 2016 Aug 23.Jing D, Hao J, Shen Y, Li ML, Huang SH, Zhao Z.The role of microRNAs in bone remodeling.Int J Oral Sci 2015:131–43




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