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MDx/CDx Focus: Austin Breast Center Offers BrevaGen; Epigenomics Studies Colon Cancer MDx vs FIT

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Austin Breast Center Offers BrevaGen Breast Cancer Risk Dx

The Breast Center of Austin this week announced that patients being treated at the facility will have access to BrevaGen, a test that assesses risk of developing non-familial or sporadic breast cancer.

According to the center, established by physician Owen Winsett in 1992, it is one of the first facilities in the US to adopt the test. Fitzroy, Australia-based Genetic Technologies launched BrevaGen in a number of US states last year.

BrevaGen, originally developed by Perlegen Sciences and later acquired by Genetic Technologies subsidiary Phenogen Sciences when Perlegen cased operations in 2010, analyzes patients' saliva for seven SNPs. The test then factors in patients' clinical information with their genetic risk score to determine their five-year and lifetime risk of getting hormone-dependent breast cancer. This risk prediction from BrevaGen is independent of family history or previous intermediate test results.


Epigenomics Kicks off Head-to-Head Comparison of Epi proColon and FIT

Epigenomics this week launched a head-to-head comparative study of its Epi proColon tests versus fecal immunochemical testing for colorectal cancer detection.

According to the company, investigators have enrolled the first participant in the trial.

Epigenomics is undertaking this head-to-head comparison after the US Food and Drug Administration asked the company to perform such a study demonstrating that Epi proColon was non-inferior to FIT.

For the head-to-head comparison, researchers are planning to recruit 100 patients confirmed to have cancer after colonoscopy and 200 asymptomatic individuals who haven't received colonoscopies. Epigenomics expects to complete this study in the second half of 2012.

"The results will be an integral part of the company’s modular premarket approval submission to the FDA" for Epi proColon, Epigenomics said in a statement.

Epi proColon is a blood-based molecular diagnostic for the early detection of colorectal cancer. The test gauges the methylated Septin9 biomarker and assesses whether patients are at high or low risk for colorectal cancer. The diagnostic is not meant to replace colonoscopies, but is intended to help physicians decide which patients need more invasive diagnosis via colonoscopy.

Epi proColon is currently marketed in Europe, but is still under development in the US.

The company has so far submitted to the FDA its first two PMA modules and is planning to file the third module in the second quarter and the fourth module in the second half of the year.


Enzo Launches ColonSentry; HCV MDx Under Development on AmpiProbe Platform

Enzo Biochem this week launched ColonSentry, a blood-based colon cancer risk stratification test developed by GeneNews.

ColonSentry gauges the expression of seven genes using a blood sample collected during a patient's routine physical exam.

The company is launching the tool "to help assess a patients’ risk for colorectal cancer, and thus drive greater compliance for use of colonoscopies, which has been very low," Enzo said in a statement. The firm is hoping that ColonSentry will help physicians detect colorectal cancer earlier.

In February, Enzo received approval from the New York State Department of Health for its clinical laboratory that will operate ColonSentry.

Under its exclusive licensing deal with GeneNews for ColonSentry, Enzo is marketing the test is New York, New Jersey, and Pennsylvania. GeneNews sells the test in Canada.

Enzo said this week that it is also in the process of developing and launching an RNA quantification assay for hepatitis C based on its AmpiProbe platform.

"This product is the first of several assays now under development based on the AmpiProbe next-generation molecular diagnostics platform that are expected to be marketed both nationally and internationally," the company said in a statement.

The Scan

Dropped Charges

The US Justice Department has dropped visa fraud charges against five Chinese researchers, according to the Wall Street Journal.

More Kids

The Associated Press says Moderna is expanding its SARS-CoV-2 vaccine study to included additional children and may include even younger children.

PNAS Papers on Rat Clues to Human Migration, Thyroid Cancer, PolyG-DS

In PNAS this week: ancient rat genome analysis gives hints to human migrations, WDR77 gene mutations in thyroid cancer, and more.

Purnell Choppin Dies

Purnell Choppin, a virologist who led the Howard Hughes Medical Institute, has died at 91, according to the Washington Post.