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Patent Awarded for Cancer-Detecting Blood Test

U.S. Patent and Trademark Office

U.S. Patent and Trademark Office. Alexandria, Virginia (A. Kotok)

10 September 2015. VolitionRx, a developer of blood tests to screen for cancer, received a U.S. patent for its underlying technology that detects changes in basic cell proteins found in blood. Patent number 9,128,086 was issued by the U.S. Patent and Trademark Office on 8 September to four inventors and assigned to the company, incorporated in Singapore, but operating from Namur, Belgium.

The patent covers techniques developed by VolitionRx for detecting indicators of disease based on the nature of histone proteins that form in the core of cells. DNA strands coil around histones and are condensed into chromatin, the material that makes up chromosomes. The pieces of DNA that wrap around histones are called nucleosomes, and when mutations form in the DNA, nucleosomes change as well, which affect the underlying histone proteins.

Changes in nucleosomes are unique for each disease condition, which makes it possible to identify the disease by a biomarker or indicator when that nucleosome change occurs. VolitionRx’s technology looks for those indicators in antibodies in blood and other fluid samples that bind to histones and appear when nucleosomes change. The patent applies to tests with this technology to detect cancer and autoimmune diseases, disorders where the immune system is tricked into attacking healthy cells rather than invading pathogens.

VolitionRx is developing tests for cancer using blood samples as small as a single drop. Its lead product tests for colorectal cancer, where screening for the disease today often requires an invasive and expensive colonoscopy. Yesterday, the company released interim results of a retrospective study of 4,800 individuals at 6 hospitals in Denmark who had colonoscopies, and later provided blood samples for analysis with the company’s test.

The results show the VolitionRx blood test detected 81 percent of the colorectal cancer cases, both in early and late stages, with 78 percent specificity, where those not having the condition were recorded as negative. The company’s test also detected 63 to 67 percent of pre-cancerous polyps, which included polyps at high risk of becoming a tumor. The company is presenting the study’s findings this week at industry and professional meetings.

VolitionRx is evaluating its technology in prospective studies of colorectal cancer, as well as current and planned studies of lung, ovarian, and prostate cancer. The company is also studying its blood test technology to detect endometriosis, a painful disorder affecting women where tissue normally found in the uterus begins growing outside the uterus in other organs. Diagnosing endometriosis usually requires a laparoscopy, a surgical procedure done under anesthesia.

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