A molecular diagnosis means establishing a diagnosis using molecular biology techniques to evaluate the patient's body changes at the molecular level. It particularly concerns identifying genes responsible for various structural proteins, enzymes, antigens, antibodies, and immunologically active molecules pertaining to the disease.
Alta DiagnoTech specializes in the area of in vitro diagnostics and remains dedicated to providing clients with excellent services in the development of tumor molecular diagnostic kits. From project evaluation and target selection in the early stages, through experimental design and reagent development in the middle stages, to performance validation and sample testing in the late stages, we are able to offer unmatched customized development solutions tailored to the client's needs.
Technologies for Molecular Diagnostic Kit Development
We use a set of sophisticated technologies that cover integral components of tumor detection with high sensitivity, specificity, and utility.
- Polymerase Chain Reaction (PCR)
This is one of the most utilized molecular diagnostic procedures. Its principle of detection lies in the amplification of particular fragment of DNA.
A known DNA probe is immobilized on a chip and hybridized with the target nucleic acid. By detecting the intensity and location of the hybridization signal, the gene expression status or mutation in the sample is detected.
- High-throughput Sequencing (NGS)
This technology evaluates the mutation profile of the tumor at the same tissue sample for somatic mutations, TMB, MSI and other markers based on Panel or Whole Exome Sequencing (WES).
- Fluorescence In Situ Hybridization (FISH)
FISH exploits probes that are complementary to the target nucleic acid sequence to the target DNA. This gene can be established if the position and amount of the fluorescent signal is observed.
In dPCR, the sample is partitioned into a very large number of independent reaction units. The molecule quantification is determined from the detection of fluorescent signals at the end points which indicates presence or absence of the molecule.
Tumor Molecular Diagnostic Kit Development Solutions
We can develop molecular diagnostic kits for a wide range of tumor types, including but not limited to the following:
Solid Tumors Diagnostic Kit
Types |
Details |
Lung Cancer |
EGFR, ALK, ROS1, RET, MET, KRAS, BRAF, NTRK, PD-L1, TMB, and other gene detection. |
Colorectal Cancer |
KRAS/NRAS/BRAF mutations, MSI/dMMR (microsatellite instability), HER2 amplification, and other gene detection. |
Breast Cancer |
HER2 amplification, PIK3CA mutation, BRCA1/2 germline mutation, ESR1 mutation, and other gene detection. |
Gastric Cancer |
HER2, PD-L1, CLDN18.2, FGFR2, and other biomarkers detection. |
Hepatocellular Cancer |
Analysis of driver genes such as TERT promoter mutation, TP53, CTNNB1, and HBV/HCV-related molecular markers. |
Prostate Cancer |
AR mutations, PTEN deletions, and BRCA1/2 mutation detection. |
Thyroid Cancer |
BRAF V600E, RET/PTC fusions, RAS mutations, and other gene detection. |
Ovarian Cancer |
BRCA1/2, HRD (homologous recombination defects) detection. |
Hematologic Tumors Diagnostic Kit
Types |
Details |
Leukemia |
BCR-ABL1 fusion gene, FLT3-ITD, NPM1, IDH1/2, TP53, and other mutation detection. |
Lymphoma |
MYD88, CD79B, EZH2 mutation and PD-L1 expression analysis. |
Multiple Myeloma |
Mutation testing for FGFR3, KRAS/NRAS, TP53, etc. |
Pan-Cancer Diagnostic Kit
Types |
Details |
TMB, MSI, and HRD |
Testing to assess immunotherapy response. |
NTRK Fusion |
Pan-cancer species target, suitable for dosing guidance of TRK inhibitors. |
Liquid Biopsy (ctDNA) |
Non-invasive monitoring of dynamic mutations in tumors for early warning of recurrence and analysis of drug resistance mechanisms. |
About Us
Equipped with fully enabled competencies in manufacturing, operational, and testing for in vitro diagnostics products, we support clients with cancer diagnostic product development services spanning the entire cancer journey from early tumor screening, disease diagnosis, drug selection, efficacy testing, to prognosis evaluation. We appreciate the role of tumor molecular diagnostics in precision medicine, which drives us to innovate and expand our product lines for enhanced efficiency and accuracy of complex testing.
Alta DiagnoTech enables clients to develop and implement tumor precision diagnostic products at an accelerated pace. We consider our client's needs and, with great flexibility, select or tailor appropriate technological approaches to ensure that the diagnostics meet the desired standards of accuracy, efficiency and are aligned with the specified research objectives. If you have any other related needs for the development of diagnostic kits, please feel free to contact us.