Geneoscopy Files Counterclaims Against Exact Sciences
July 01 2024 - 8:15AM
Business Wire
The Company is confident that litigation will
not delay the commercial launch of ColoSense™, its FDA-approved RNA
biomarker screening test for colorectal cancer and advanced
adenomas
Geneoscopy, Inc., a life sciences company focused on developing
diagnostic tests for the advancement of gastrointestinal health,
filed a lawsuit asserting multiple claims for damages against Exact
Sciences on June 28, 2024, in federal court in the District of
Delaware.
The claims include breach of contract, misappropriation of trade
secrets, unfair competition, and other violations of state and
federal law that Exact Sciences has committed against Geneoscopy.
The Company is seeking remedies including, but not limited to,
compensatory and punitive damages, payment of Geneoscopy’s
attorneys’ fees, and other legal and equitable remedies.
“We are taking action due to Exact Sciences’ continued wrongful
and malicious conduct, including the misappropriation of our
proprietary information and trade secrets,” said Andrew Barnell,
CEO and co-founder of Geneoscopy. “Attempting to block new products
from the market limits screening options for the 44 million
Americans at average risk for CRC. We believe our countersuit is an
important next step to ensure fair competition and prevent Exact
Sciences from impeding innovation and advancement in the field of
cancer detection.”
Also on June 28, Exact Sciences filed a motion for a preliminary
injunction against Geneoscopy. The motion, filed seven months after
the initial suit, is based on two related patent infringement
claims, which are limited to specific methods of collecting and
processing stool samples. Geneoscopy believes that Exact Sciences’
patent suit and the belated preliminary injunction motion are
baseless, and it will vigorously defend its position in court.
“This filing in no way affects our confidence in the strength of
our intellectual property,” Barnell said. “We are on track with the
commercial launch timeline for ColoSense and remain dedicated to
expanding choice and access to safe, effective, and convenient
screening options for everyone, potentially saving countless
lives.”
Colorectal cancer is the second deadliest cancer in the U.S.,
with incidence rates rising among younger populations under 50. In
response to this growing concern, the U.S. Preventive Services Task
Force updated its guidelines to recommend CRC screening starts at
age 45. Despite this, millions of eligible Americans avoid
screening due to limited access or the invasive nature of options
like colonoscopies. This issue is compounded by the fact that only
1 out of 5 people in the 45-49 age group receive screening.
ColoSense is the first noninvasive colorectal cancer screening test
to use RNA biomarkers to provide a dynamic view of disease
activity, which are not subject to age-related methylation patterns
that can lead to variability in test performance across different
age groups.1,2
Related Proceeding
Geneoscopy has separately petitioned the U.S. Patent and
Trademark Office (USPTO) to institute an inter partes review
challenging the patentability of the U.S. Patent No. 11,634,781. As
Geneoscopy’s petition explains, nothing in that patent (which Exact
purchased from a third party) is inventive. Separating a fecal
sample so it can be tested for both blood proteins and nucleic
acids is reported throughout the prior art. Moreover, fecal tests
for detecting blood protein and nucleic acids, as recited by the
claims, are standard, and the patent purports to claim only routine
methods for preparing a fecal sample for the performance of
well-established complementary diagnostic assays. The claimed
method of the ’781 patent is obvious, and the claims directed to
the method are invalid.
About ColoSense
ColoSense is intended for the qualitative detection of
colorectal neoplasia-associated RNA markers and for the presence of
occult hemoglobin in human stool. ColoSense is for use with the
ColoSense Collection Kit, the ColoSense Test Kit, the ColoSense
Software, and the following instruments: Polymedco iFOBT Analyzer;
bioMérieux EMAG Nucleic Acid Extraction System; and Bio-Rad QXDx
ddPCR System. ColoSense is a single-site test performed at
Geneoscopy, Inc.
A positive ColoSense result may indicate the presence of
colorectal cancer (CRC), advanced adenomas (AA), or serrated
precancerous lesions (SPL) and should be followed by a colonoscopy.
ColoSense is indicated as a screening test for adults, 45 years of
age or older, who are at typical average risk for developing CRC.
ColoSense is not a replacement for diagnostic colonoscopy or
surveillance colonoscopy in high-risk individuals.
Results from Geneoscopy’s pivotal CRC-PREVENT trial were
published in The Journal of the American Medical Association (JAMA)
in October 2023. For more information, visit www.colosense.com.
About Geneoscopy, Inc.
Geneoscopy, Inc. is a life sciences company focused on
developing diagnostic tests for gastrointestinal health. Leveraging
its proprietary, patented stool-derived eukaryotic RNA (seRNA)
biomarker platform, Geneoscopy’s mission is to empower patients and
providers to transform gastrointestinal health through innovative
diagnostics. Beyond colorectal cancer screening, Geneoscopy is
developing diagnostic tests for treatment selection and therapy
monitoring in other disease areas in partnership with leading
universities and biopharmaceutical companies. For more information,
visit www.geneoscopy.com and follow the company on LinkedIn.
References:
- Ahlquist DA, Taylor WR, Yab TC, et al. Abstract 3572:
Methylated gene marker levels in stool: Effects of demographic,
drug, and body mass and other patient characteristics. Cancer
Research. 2012;72(8_Supplement):3572-3572.
https://doi.org/10.1158/1538-7445.am2012-3572
- Ahlquist DA, Taylor WR, Yab TC, Devens ME, Mahoney DW, et al.
Aberrantly methylated gene marker levels in stool: effects of
demographic, exposure, body mass, and other patient
characteristics. J Mol Biomark Diagn. 2012;3:133.
doi:10.4172/2155-9929.1000133
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Geneoscopy Contacts: Media Andrea Sampson Sampson Public
Relations Group asampson@sampsonprgroup.com
Investor Relations Carrie Mendivil / Ji-Yon Yi Gilmartin Group
investors@geneoscopy.com