The current advent of molecular technologies together with a multidisciplinary interplay of several fields led to the development of in vitro diagnostics (IVD), which concentrates on the detection of pathogenic events at the nucleic acid and protein level. Various promising technologies and diagnostic applications are currently paving the way for the rapid diagnosis of disease. Armed with rich experience in IVD and an excellent technical team, Creative Biolabs provides a comprehensive set of gene diagnosis and analysis services for worldwide clients.

The Gold Standard in Diagnostic Testing

Currently, polymerase chain reaction (PCR) technology is considered the gold standard by many across the diagnostic community, since it can theoretically identify and detect a target with a single copy present in the sample. PCR technology is also rapid and can be performed in hours to minutes compared to serology and pathogen culture and isolation, which is labor intensive and can take long time to produce a result. Serology or culture may not provide the same level of sensitivity as PCR. Therefore, the risk of false negatives increases in critical testing scenarios where organisms or viruses may be difficult to grow or detect an immune response to.

Gene Level

Detection Methods

Classical molecular techniques like normal PCR and blotting although played satisfactory roles in diagnosis. However, currently, molecular techniques may detect more precisely and specifically without consuming much time. A wide range of molecular based tests is available to evaluate DNA difference and changes in gene through real-time PCR, fluorescent in situ hybridization (FISH), enzymatic-based methods, electrophoretic-based techniques, solid phase-based techniques/hybridization or blotting techniques, microarrays, sequencing, CRISPR-based method, and so forth.

CRISPR-Cas13a can quantitatively detect SARS-CoV-2 RNA without pre-amplification.Fig.1 CRISPR-Cas13a can quantitatively detect SARS-CoV-2 RNA without pre-amplification. (Katalani, 2020)

Current Scenario of Gene Diagnosis in Various Diseases

  • Over the past two decades, the relentless progress and application of genetic diagnostic techniques have opened new vistas in the diagnosis of various diseases such as infectious diseases, neurodegenerative disorders, cancers and genetic diseases. For instance, the FISH is a highly valuable tool for the specific and rapid detection of pathogenic bacteria in clinical samples without cultivation. FISH technique has allowed for the development of low cost DNA probe methods that detect C. trachomatis or N. gonorrhea.
  • Recently, a study has developed a new oligonucleotide microarray comprising 16 identical subarrays for simultaneous rapid detection of avian viruses: avian influenza virus (AIV), Newcastle disease virus (NDV), infection bronchitis virus (IBV), and infectious bursal disease virus (IBDV) in single- and mixed-virus infections. Diagnostic effectiveness of the developed DNA microarray has been 99.18%.
  • Cancerous cells sometimes have mutations in oncogenes, such as KRAS and CTNNB1 (β-catenin). Analyzing the molecular signature of cancerous cells, the DNA and its levels of expression via messenger RNA enables researchers to characterize cancer and find their way for drug development.

Diagnostic Services

Better diagnostic tests have led to the development of more targeted therapies, further developing the scope for better healthcare facilities. The real-time PCR-based platform holds great promise in replacing conventional laboratory-based testing for future point-of-care (POC) testing. With advancements in automation, integration of specimen preparation with target identification, and miniaturization, it will become much easier to bring analyses near the bedside to be done by less-trained personnel. Creative Biolabs, along with global partners, supports the development of gene diagnostic to strengthen IVD research. Creative Biolabs provides specific technical assistance in the following areas:

Our state-of-the-art genetic and protein biomarker testing remains the core of what we do. If you are interested in our services, please feel free to contact us.

Reference

  1. Katalani, C.; et al. CRISPR-Based Diagnosis of Infectious and Noninfectious Diseases. Biological procedures online. 2020, 22(1): 1-14.

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