Common Types of Molecular Diagnostics Used in Clinical Labs

Clinical diagnostics have changed a great deal over the years. Labs used to focus mainly on looking at cell shapes under the microscope. Now they study the genetic and molecular causes behind diseases. Molecular diagnostics (MDx) have become the main tool in precision oncology, handling infectious diseases, and tailoring treatments to patients. Picking the right test matters for getting accurate results. Celnovte, a worldwide company with more than 30 years in advanced pathological diagnostic reagents and instruments, leads the way in these developments.

Defining the Core Categories of Molecular Diagnostics

Molecular diagnostics cover the methods used to examine biological markers in DNA, RNA, and proteins. These tests spot particular sequences in genetic material. Doctors can find mutations, fusions, or viral insertions well before they show up as changes visible in tissue slides.

In-Situ Hybridization (ISH): Mapping Genes Within the Tissue

In-Situ Hybridization (ISH) stands out because it shows where specific nucleic acid sequences sit inside a tissue sample that stays intact. This location information helps pathologists see precisely which cells carry a genetic problem. PCR mixes everything together and loses that location detail. ISH, however, keeps the tissue structure clear.

Polymerase Chain Reaction (PCR) and Nucleic Acid Extraction

PCR continues to be a key method for copying small amounts of DNA or RNA many times over. The whole process works best when the starting sample is clean and pure. Celnovte helps labs at this early stage with modern Nucleic Acid Extractors. These machines deliver high-quality material for later molecular tests.

Next-Generation Sequencing (NGS) and Its Diagnostic Role

NGS has transformed laboratories by reading millions of DNA pieces at the same time. It gives a wide view of genetic changes. Still, findings from NGS often need confirmation with focused tests such as FISH or IHC. These follow-up steps check if a variant truly matters inside the tumor tissue.

Advanced Solutions in In-Situ Hybridization: FISH vs. CISH

In molecular pathology, ISH splits into two main types based on how signals appear: Fluorescence (FISH) and Chromogenic (CISH). Celnovte offers strong product lines in both areas. This choice lets labs pick what fits their needs best.

FISH: High-Resolution Fluorescence for Chromosomal Analysis

Fluorescence In-Situ Hybridization (FISH) relies on glowing probes that attach to certain chromosome sections. It serves as the trusted method for spotting gene copies (such as HER2 in breast cancer) and chromosome swaps. Celnovte launched more than 100 FISH probes back in 2017. Demand was rising for reliable tumor diagnostics at that time.

Celnovte’s FISH probes stand out due to their sharp signals against low background noise. Pathologists can clearly see deletions or rearrangements. In busy clinical labs, these probes provide quick, detailed genetic information. Doctors then use it to choose targeted treatments.

Super-ISH™ CISH: Single-Molecular Level Detection Under Brightfield

FISH works well, but it needs special dark-field microscopes. Signals also fade after a while. Celnovte created Super-ISH™ RNA In-Situ Hybridization technology to address these issues.

Super-ISH™ brings a major step forward in color-based detection. It spots RNA targets down to single molecules and individual cells. The color reaction means slides can be viewed on ordinary light microscopes. Stains stay permanent without fading. This approach shines when looking for markers that traditional IHC struggles to find. It delivers molecular detail while fitting smoothly into standard pathology routines.

Automation: The Backbone of the Modern Molecular Lab

Molecular testing volumes keep growing. Hand processing slows things down and raises error risks. Automated systems have become essential for steady results and fewer mistakes. Celnovte has placed over 1000 fully automated stainers around the world since 2018.

Streamlining Workflows with the CNT 360 Fully Automatic Stainer

The CNT 360 handles high numbers of slides and combines IHC and ISH steps on one machine. In today’s clinical settings, it runs several staining protocols at once. Turnaround times drop noticeably.

A key strength of the CNT 360 lies in managing demanding assays like CISH right alongside routine IHC. Precision and speed stay high. Labs that use Celnovte’s ready-to-use (RTU) reagent kits get consistent staining with little hands-on work. This setup proves vital for centers that process many samples daily.

Clinical Precision in Cytology: p16/Ki-67 and HPV E6/E7 Probes

Molecular tests also matter greatly in cytology work. Take p16/Ki-67 dual staining as an example. It helps diagnose HPV-related cancers in the throat and cervix areas. Mixing these two markers raises accuracy far above old Pap smear methods. Doctors better separate passing infections from serious lesions.

Celnovte’s HPV E6/E7 probes target important viral oncogenes. Recent research shows spotting these genes helps predict how cancer might advance. The probes offer strong sensitivity. Even small amounts of viral material show up clearly. This detection guides treatment choices and affects patient results directly.

Conclusion: Empowering the Future of Pathology with Celnovte

How well molecular diagnostics perform comes down to how clear the findings are. Super-ISH™ gives single-cell clarity. The CNT 360 stainer delivers reliable high-volume work. FISH probes bring diagnostic confidence. Celnovte focuses on raising accuracy in cancer testing through all these tools.

Production sites follow NMPA, GMP, ISO13485, and FDA rules. Every reagent and machine meets top global standards. Liver cancer and other serious diseases still cause many deaths worldwide. Reliable molecular tools remain in high demand. Celnovte stays ready to support labs everywhere. We help them improve results and care for the people they treat.

FAQ

Q: What is the main advantage of Super-ISH™ over traditional ISH?  

A: Super-ISH™ allows for the detection of RNA at the single-molecular level and single-cell resolution using a standard light microscope, ensuring permanent signals and high sensitivity.

Q: Can the CNT 360 stainer perform both IHC and ISH?  

A: Yes, the CNT 360 is a fully automatic all-in-one platform designed to execute both IHC and ISH protocols, providing high-throughput capabilities and fast turnaround times.

Q: Are Celnovte’s molecular products certified for clinical use?  

A: Absolutely. Celnovte’s facilities and products are compliant with NMPA, FDA, CE-IVD, and ISO13485 standards, ensuring they meet the rigorous requirements of clinical diagnostic labs.

Q: Why is p16/Ki-67 dual staining important in HPV diagnostics?  

A: It serves as a powerful molecular marker that improves diagnostic specificity for HPV-related lesions, helping clinicians distinguish high-risk cases from transient infections.