Chronix Biomedical filed its first patent application 20 years ago on October 4, 1996. This first patent application has subsequently led to a series of exciting developments culminating in revolutionary genetic testing technology to diagnose cancer early, accurately and rapidly monitor response to treatment, all from a simple blood test.

The project began as an attempt to understand why so many military personnel were coming down with various symptoms known collectively as Gulf War Illnesses. Chronix researchers reasoned that many of the symptoms had similarities to various disorders related to a class of viruses known as enteroviruses. It was known that many of the military personnel received several vaccines before their deployment of which one vaccine was the enterovirus polio. The hypothesis was that perhaps the poliovirus had mutated as a result of the toxic exposures of the Persian Gulf War.

Blood samples were obtained from veterans suffering from GWI and from apparently healthy blood bank donors. Poliovirus is an RNA virus so RNA was extracted from cell-free serum and probed for the presence of poliovirus or perhaps a viral mutation. The results were shocking in that instead of a clear band on a gel where the poliovirus segments should be, a virtual smear was found.

Figure 1A:

The bands were extracted, sequenced and matched with the relatively recent BLAST website. The results led the investigators to conclude that unique sequence motifs found in the cell-free nucleic sequences were from the immune system hotspot used for gene-rearrangements-Chromosome 22q11-12.

It would appear that this is the first report of mapping cell-free nucleic acids precisely with the human genome-5 years before the entire human genome was published.

1996 was also important in that the FDA had approved a test for measuring the viral load of HIV in blood. The introduction of a real-time measurement of the dynamics of the virus in a patient allowed for a deeper understanding of the disease and an early feedback of which combinations of anti-retroviral therapies should be used. The viral load test has allowed for fewer people to die unnecessarily of AIDS where medications are available. The invention described in the October 4, 1996 Chronix Biomedical patent application was modeled on the success of the viral load test: “The detection methods of the invention can also be used to monitor the success of treatment of disease.”

Three things needed to happen to be able to provide a “cancer load test.” First, the entire human genome needed to get finished. Second, computers needed to get more powerful. Third, we needed to sequence whole genomes in a reasonable time.

And so twenty years later with constantly updated human genome, amazing computers and remarkable next-generation sequencers, Chronix Biomedical announced at the 2016 ASCO meeting its cancer load test to fight cancer.

The latest novel tests build on past learnings to analyse whole DNA fragments and cancer load changes. A long journey of learning has led to our ability to allow early cancer screening and diagnosis and quickly predict therapy outcomes.

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Happy Anniversary to all our friencs and colleagues at Chronix Biomedical.

The lessons learned from problems of the past are the solutions for the future.


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