A diagnostic test can be performed by a variety of invasive or non-invasive methods. An invasive method involves a surgery or biopsy that is possibly associated with various risks and complications and is usually fairly expensive to perform. Non-invasive techniques include examinations of blood, plasma, serum, and cells for various analytes (e.g., circulating nucleic acids) that can detect, predict and monitor diverse clinical conditions and outcomes. Other biological fluids and excrements such as urine, sweat, saliva and stool have also been investigated as a source for non-invasive procedures for a wide variety of diseases.
However, the major limitations of the existing non-invasive methods lie in the technical challenge for a reliable detection of informative signals due to an indirect measurement, low sample quantity and high background within the obtained sample materials. These fundamental problems of non-invasive diagnostic techniques make it difficult to apply this strategy within a clinical setting and lead to unreliable and inconsistent results.
The discovery of trace amounts of informative signal molecules in a wide range of biological samples that can be collected non-invasively (blood, plasma, serum, urine, saliva, stool and sweat) presents a completely new way to efficiently approach old clinical problems. Detecting and quantifying foreign and aberrant nucleic acids within the high background of host-derived normal nucleic acids for detecting, predicting and monitoring a state or disease such as infection, organ transplant rejection, fetal health and cancer diagnosis have received great attention recently due to technological advancement that offers an opportunity for better and more reliable detection of challenging signals from non-invasively collected samples.
Diagnomics’ proprietary Digital Genomic Fingerprinting (DGF) is very powerful to detect personal genome patterns in a digital way by precisely counting signals and accurately subtracting any technical errors or bias during the detection process. Diagnomics DGF technology can be widely applied to challenging samples collected non-invasively for the molecular diagnosis of a wide variety of diseases such as cancer, infections, organ transplant and pre-natal health monitoring.