Pgdx liquid biopsy market
NEW YORK GenomeWeb — Chronix Biomedical has published a clinical validation study of a next- generation sequencing-based test that analyzes circulating cell-free DNA to gauge whether the patient is at high risk for prostate cancer and should go on to receive a pgdx liquid biopsy market.
The goal is to provide pgdx liquid biopsy market clearer guide of who is at high risk for developing prostate cancer and should receive further testing, reducing the numbers of unnecessary biopsies. Currently, PSA testing has a false positive rate of nearly 75 percent, he said, leading to many unnecessary, invasive, and costly biopsies. While very high levels of PSA are typically indicative of prostate cancer, most men have PSA levels in the intermediate zone, Urnovitz said.
Offering a noninvasive NGS-based test for those patients should help clarify who should go on to receive biopsies. In its validation studywhich was published this month in Clinical Chemistry, Chronix collaborated with researchers at Vanderbilt University. They ran the test in pgdx liquid biopsy market than patients, including patients with confirmed prostate cancer and controls. In addition, they evaluated 20 patients with either benign prostate hypertrophy or prostatitis, conditions known to elicit a false positive result with standard PSA testing.
To design their test, the researchers first performed whole-genome amplification on the cell-free DNA using random primers tagged with molecular identifiers.
Next, they did whole-genome sequencing and aligned the reads to the human genome. Sequence reads were evaluated in kbp bins and chromosomal variations were evaluated for their ability to distinguish patients from matched controls. The Chronix researchers first used a subset of 82 prostate cancer samples and 95 controls to pgdx liquid biopsy market which copy number variants differed between the two sets and could be used as markers of genomic instability for the test.
For each sample, they generated a copy number instability score, defined by the number of bins that had higher- or lower-than-expected read counts, which could correlate with a CNV. After several rounds of testing and validation the group identified 20 regions on which to validate its final test. For a commercial test, Chronix will use pgdx liquid biopsy market targeted approach, and pgdx liquid biopsy market firm holds a patent on its hybridization method for detecting disease-specific cell-free nucleic acids.
The team used ROC curves pgdx liquid biopsy market assess diagnostic performance, showing that its test could discriminate prostate cancer from controls with an area under the curve of.
The test performed slightly better when the control set was limited to patients with a Gleason score of less than 7, and was good at pgdx liquid biopsy market prostate cancer cases from both benign prostatitic hypertrophy and prostatitis, demonstrating an accuracy of 90 percent. The Chronix test is "a heck of a lot better pgdx liquid biopsy market PSA testing," Bill Mitchell, a professor of pathology, microbiology and immunology at Vanderbilt University and corresponding author of the paper, told GenomeWeb.
Urnovitz noted that the test's accuracy is not high enough to serve as a definitive diagnostic test, which is one reason why Chronix is positioning it as either a confirmatory or supplementary test to PSA testing for patients with intermediate scores. Urnovitz said the company is also working on improving the test's pgdx liquid biopsy market and diagnostic capabilities. In the study, the Chronix team used Thermo Fisher's SOLiD platform to do the sequencing, but Urnovitz said that the test would be launched commercially on a different, undisclosed platform.
Urnovitz noted that Chronix is also considering partnering with other companies in order to commercialize the test in the US and he said he would like to eventually bring the test through US Food and Drug Pgdx liquid biopsy market clearance.
InMyriad licensed technology from Chronix, but returned the licenses in Urnovitz said that Myriad had been considering the technology as a screening test, rather than as a PSA supplemental test. Chronix also has a similar test in the works for breast cancer, which Urnovitz said would be its next product.
At the American Society for Clinical Oncology meeting, Chronix researchers presented a poster that showed that NGS pgdx liquid biopsy market circulating cell-free DNA could monitor breast cancer patients for minimal residual disease following surgery. Urnovitz said that the company plans to publish the results of its breast cancer test.
Chronix is one of several companies looking to tap into the so-called liquid biopsy space. Urnovitz said that Chronix aims to differentiate itself from these potential competitors by offering its test at a low price point, something it is able to do because it is targeted and evaluates copy numbers, which doesn't require as much sequencing depth as looking at point mutations. In addition, he said that the company is focused initially on a very specific market to which it can add value and cost savings — the indeterminate risk market.
Vanderbilt's Mitchell added that NGS-based testing of circulating tumor DNA holds great clinical potential not just in prostate cancer, but likely many other areas. He said that in collaboration with Chronix, Vanderbilt researchers have shown the potential for such testing in breast and head and neck cancers.
A revolution in cancer diagnostics is occurring using in vitro blood testing to identify cancer DNA. The technology creates new markets for cancer screening tests. GRAIL, a new company with impressive backing, has announced a single blood test to detect all cancers. The technology is moving faster than the market. New technology that definitively identifies disease conditions from blood samples is poised to replace expensive invasive surgical biopsy procedures.
The market is still in its infancy but has outstanding growth potential. The impact on the health care industry is enormous. The report forecasts the market size out to In addition, the report looks at potential market sizes by country, by cancer and by the three different opportunities: Use independent research that makes you the expert.
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Find out about the technology in readily understood terms that explain the jargon. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size. What is the size of the huge screening opportunity? They are all listed in Chapter Introduction and Market Definition 1. Liquid Biopsy Recent Developments 4. Country Market Sizes - North America 5. Country Markets - Europe 6. Country Markets - Asia Pacific 7.
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