GenCerv Screening Expected to Reduce Unnecessary and Risky
Colposcopy and Biopsy Procedures
ELMWOOD PARK, N.J.--(BUSINESS WIRE)--Apr. 30, 2012--
Bio-Reference Laboratories, Inc. (“BRLI”) (NASDAQ: BRLI) announced today
that it has completed an equity investment in InCellDx, Inc.
(“InCellDx”), a privately held molecular diagnostics start-up company
dedicated to the detection and monitoring of life -threatening diseases
such as cervical cancer, breast cancer, HIV/AIDs, hepatitis and organ
transplant rejection. In addition, BRLI’s GenPath Women’s Health has
developed and launched a new test called GenCerv, based on the
InCellDx’s patented and proprietary HPV mRNA quantification technology.
“95% of women who test positive for high-risk HPV do not progress to
cervical cancer. We believe the GenCerv test will help physicians
identify the subset of HPV DNA positive patients that progress to
cervical cancer,” said Bruce Patterson, MD, CEO and founder of InCellDx.
“Our technology is being used extensively in Europe and we look forward
to working with BRLI and GenPath Women’s Health as we seek to reach our
InCellDx technology enables quantification of molecular biomarkers
inside intact cells using cell-based instruments and in-situ
hybridization. This process allows protein and gene expression to be
measured by distinct cell type, aiding in both diagnosis and disease
localization. GenPath adapted this technology for the quantification of
E6/E7 mRNA in HPV.
“We believe that the science behind InCellDx is compelling. 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.” said Marc Grodman, MD, President and CEO of BRLI. “We
anticipate that this technology, which has been well reviewed in
academic publications, 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.”
GenPath launched the GenCerv HPV E6/E7 oncogene quantification assay
this month and it is available to GenPath physician customers throughout
the United States. “We are proud to have been able to develop a test
based on this technology,” said James Weisberger, MD, Chief Medical
Officer and Laboratory Director of GenPath. “We believe that this test
has a high positive predictive value for high grade cervical dysplasia
in cervical biopsies. We expect that quantitative HPV E6/E7 testing will
provide information that should limit the colposcopies and cervical
biopsies performed to a higher percentage of those cases where there is
a high clinical probability of the HPV infection progressing to cervical
BRLI has entered into an agreement with InCellDx, a Delaware corporation
having its place of business in Menlo Park, California, pursuant to
which BRLI has purchased for $6 million ($4 million cash investment and
$2 million by promissory note) shares of preferred stock and warrants
representing between 20% and 25% of InCellDx, depending on dilution
resulting from the exercise of outstanding options. The promissory note
is payable to InCellDx on an as-needed basis and the amount of the note
and corresponding number of shares and warrants will be proportionately
reduced if the entire $2 million is not needed. BRLI expects to invest
the entire $2 million within the next six months. Dr. Grodman will be
chairman of the board of directors of InCellDx and Charles T. Todd of
BRLI will also be appointed to the six person InCellDx board. InCellDx
had total revenues in 2011 of approximately $1,121,000.
BRLI is filing an 8-K providing further details on its investment in
About Bio-Reference Laboratories, Inc.
BRLI is a clinical testing laboratory offering testing, information and
related services to physician offices, clinics, hospitals, employers and
governmental units. We believe that we are the fourth largest
full-service laboratory in the United States and the largest independent
regional laboratory in the Northeastern market. BRLI offers a
comprehensive list of laboratory testing services utilized by healthcare
providers in the detection, diagnosis, evaluation, monitoring and
treatment of diseases. BRLI primarily focuses on esoteric testing,
molecular diagnostics, anatomical pathology, women’s health and
correctional health care.
About InCellDx, Inc.
InCellDx, Inc. is a molecular diagnostics company dedicated to the
detection and monitoring of life threatening diseases such as cervical
cancer, breast cancer, HIV/AIDs, hepatitis, and organ transplant
Source: Bio-Reference Laboratories, Inc.
Bio-Reference Laboratories, Inc.
Tara Mackay, 201-791-2600