Clinical Genomics closed a $15 million Series A financing round, and will use the funding to commercialize its two-gene blood test for monitoring colorectal cancer recurrence after surgery, according to a press release.
“This financing, our first institutional capital raise, will provide critical resources to support the commercialization of our patent-pending, two-gene, blood-based assay for colorectal cancer surveillance,” Lawrence LaPointe, PhD, President and CEO of Clinical Genomics, said in the press release. “Clinical data show that our test is approximately 2.5 times more sensitive than the current guidelines-recommended standard periodic blood test, and we are optimistic that our liquid biopsy technology has the potential to address an unmet need in colorectal cancer recurrence monitoring.”
Researchers presented data supporting the effectiveness of this blood test, which detects methylated BCAT1 and IKZF1, in two posters at the ASCO GI Cancers Symposium in January.
The first group presented data from an observational study comparing the sensitivity and specificity of the 2-gene blood test with carcinoembryonic antigen (CEA) testing for detection of recurrent CRC. Interim data were presented on 30 patients with CRC recurrence confirmed via radiological imaging and 90 patients with no evidence of recurrence.
The two-gene test achieved a 63% overall sensitivity vs. 23% for CEA for detection of recurrence in the 30 patients with confirmed recurrence, according to a separate press release. The test achieved an 86% specificity in the 90 patients with no evidence of disease vs. 96% for CEA. No confirmed cases were CEA positive only.
“Two-gene test positivity correlated with local (55%) and distant (68%) recurrence with 2.7-fold more recurrence cases detected than with CEA,” according to the poster. “The two-gene test appears to be better than CEA for recurrence monitoring. Studies evaluating effect on survival are now warranted.”
The second group presented data from an observational study comparing methylated BCAT1 and IKZF1 in matched plasma and tissue samples from 75 CRC patients. Researchers detected BCAT1 in 35 of the matching plasma samples and IKZF1 in 36. They further observed at least one methylated gene in 48 samples.
“While the concentration of methylated BCAT1 and IKZF1 DNA in plasma was not linked to tissue concentration, there was a positive correlation between the presence of the methylated genes in plasma and the depth of tumor invasion and lymph node invasion,” according to the press release. “These results demonstrate that BCAT1 and IKZF1 are highly methylated in colorectal cancer tissue with low methylation levels in surrounding non-tumor tissue, suggesting that these methylated genes are highly tumor-specific without a field effect. The presence of methylated BCAT1 and IKZF1 in blood appears to be related to tumor invasiveness, enabling tumor access to the bloodstream.”
Clinical Genomics plans to offer this test in the United States later this year, according to the press release. – by Adam Leitenberger
Pedersen SK, et al. Abstract 495. Presented at: Gastrointestinal Cancers Symposium; Jan. 21-23, 2016; San Francisco.
Symonds EL, et al. Abstract 543. Presented at: Gastrointestinal Cancers Symposium; Jan. 21-23, 2016; San Francisco.
Disclosure: LaPointe is employed by Clinical Genomics.