Here is an interesting company that is quickly bringing to market a "Blood-Biopsy."
Transgenomic, Inc. (TBIO), a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through diagnostic tests as well as clinical and research services, today announced that the U.S. Patent and Trademark Office (USPTO) has issued a new patent related to its licensed ICE COLD-PCR technology. The patent, titled “Full cold-PCR enrichment with reference blocking sequence”, was assigned U.S. Patent No. 8,623,603 and is set to expire in 2031.
“This newly issued patent significantly strengthens our intellectual property portfolio and further supports the ongoing development of this cutting-edge technology that has the potential to revolutionize cancer screening, diagnosis, monitoring, and treatment selection, as well as replacing the need for biopsies and reducing this massive cost to the healthcare system,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We intend to leverage this proprietary asset immediately in both our patient testing business and with our pharmaceutical and biotechnology client companies, the primary market for ICE COLD-PCR, especially those looking for low level mutations in blood. A strong patent position is at the core of our business model and strengthens our competitive advantage in the marketplace.”
The new U.S. patent extends the scope and longevity of the COLD-PCR intellectual property portfolio. The '603 patent covers ICE COLD-PCR methods for enriching low abundance alleles in nucleic acid samples. It is directed in particular to the use of an excess amount of reference blocking sequence in an amplification reaction mixture in order to improve the enrichment efficiency, and reduce cycle time, of full COLD-PCR. The new patent reinforces Transgenomic's ICE COLD-PCR technology platform alongside its other high sensitivity mutation detection technologies, such as SURVEYOR® Scan and BLOCker™- Sequencing. Originally developed by the Makrigiorgos laboratory, the '603 patent is owned by the Dana-Farber Cancer Institute and licensed to Transgenomic.
About ICE COLD-PCR
ICE COLD-PCR (Improved and Complete Enrichment COamplification at Lower Denaturation temperature) technology was originally developed by the Dana-Farber Cancer Institute and is supported by multiple validation studies confirming reproducible mutation detection at very high sensitivity. It selectively amplifies mutant DNA by exploiting differences in denaturation temperatures between mutant/blocker DNA duplexes and wild-type (normal)/blocker DNA duplexes. ICE COLD-PCR is able to detect mutant DNA occurring in as low as 0.01% frequency in a majority of wild-type populations which results in 100-400 fold improvements in detection limits. ICE COLD-PCR is ideal for standard Sanger sequencing, next generation sequencing, digital PCR and other technologies.
The ICE COLD-PCR technology is not specific to a single mutation within a DNA target but enables detection of any mutation in a given region of DNA. This approach allows clinicians to use small amounts of sample for genetic analysis or non-invasive sample collection methods (e.g., a blood draw) to enable detection of mutant DNA species present in serum or plasma, circulating tumor cells, urine, or bronchial lavage specimens. DNA can also be analyzed from fine needle aspirates, core-biopsies, or directly from tumors. Since ICE COLD-PCR can detect low level mutations in samples where an abundance of “normal” DNA exists, such as blood, repeated assessments of a patient’s disease status can be determined without having to take additional biopsies from the tumor.
