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MDx/CDx Focus: BRL Launches IHPV mRNA Test; BrevaGen Adoption Continues in Texas


BRL launches InCellDx's HPV mRNA Test

Bio-Reference Laboratories announced this week that its GenPath Women's Health division has launched a new test called GenCerv.

The test is based on InCellDx's patented and proprietary HPV mRNA quantification technology. GenCerv will quantify E6 and E7 oncogene overexpression in distinct cell types, which, according to BRL, will help doctors diagnose HPV and identify patients whose disease will not progress to cervical cancer.

"HPV is a surrogate for the disease process that results in cervical cancer. By allowing for the quantification of E6 and E7 oncogene overexpression, our assay based on InCellDx technology seeks to track the neoplastic process; therefore, it is not about the infection, it's about the disease." Marc Grodman, CEO of BRL, said in a statement. "We anticipate that this technology … should not only improve the specificity that accompanies HPV testing, but also should be cost effective in identifying those HPV cases that do not progress to cervical cancer."

Specifically, the company is hoping that the HPV test can help reduce unnecessary colposcopies and cervical biopsies in those with a low risk of getting cervical cancer following an HPV infection.

Additionally, BRLI said it has purchased $6 million worth of preferred stock and warrants in Menlo Park, Calif.-based InCellDx, representing between 20 percent and 25 percent of the company.

BrevaGen Adoption Expands to North Texas

Personalized Women's Healthcare, a facility located in North Texas, will begin offering testing on BrevaGen, a molecular diagnostic that gauges women's risk of developing non-familial or sporadic breast cancer.

Specifically, ObGyn Eric Jacoby at Personalized Women's Healthcare in Plano, Texas, will make the BrevaGen test available to his patients.

"Determining the appropriate level of surveillance is critical for patient compliance, early cancer detection, and controlling healthcare costs," Jacoby said in a statement. "BrevaGen helps me identify those patients that benefit from a more intensive surveillance. This proactive approach might include breast MRI and/or the use of anti-estrogen medications, coupled with patient lifestyle changes, all focused on the prevention or early detection of breast cancer."

Last month, the Breast Center of Austin similarly announced that patients being treated at its facility will have access to the test (PGx Reporter 4/11/2012).

BrevaGen – originally developed by Perlegen Sciences and later acquired by Genetic Technologies subsidiary Phenogen Sciences when Perlegen ceased 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.

The Scan

Removal Inquiry

The Wall Street Journal reports that US lawmakers are seeking additional information about the request to remove SARS-CoV-2 sequence data from a database run by the National Institutes of Health.

Likely to End in Spring

Free lateral flow testing for SARS-CoV-2 may end in the UK by next spring, the head of Innova Medical Group says, according to the Financial Times.

Searching for More Codes

NPR reports that the US Department of Justice has accused an insurance and a data mining company of fraud.

Genome Biology Papers on GWAS Fine-Mapping Method, COVID-19 Susceptibility, Rheumatoid Arthritis

In Genome Biology this week: integrative fine-mapping approach, analysis of locus linked to COVID-19 susceptibility and severity, and more.