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TEST:
COLVERA™

Type:
Laboratory Developed Test
Evidence

News

7ms
BCAT1, IKZF1 and SEPT9: methylated DNA biomarkers for detection of pan-gastrointestinal adenocarcinomas. (PubMed, Biomarkers)
Hypermethylated DNA biomarkers BCAT1, IKZF1 and SEPT9 were largely stable across different stages of disease and were highly selective for gastrointestinal adenocarcinomas relative to other cancer types. Existing CRC methylated ctDNA blood tests for BCAT1/IKZF1 and SEPT9 might be usefully repurposed for use in other gastrointestinal adenocarcinomas and warrant further prospective ctDNA studies.
Journal
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IKZF1 (IKAROS Family Zinc Finger 1) • BCAT1 (Branched Chain Amino Acid Transaminase 1 ) • SEPTIN9 (Septin 9)
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COLVERA™ • Epi proColon®
almost3years
Clinical Genomics Announces New Publication from Flinders Medical Centre, Highlighting the Use of COLVERA as a Quantitative ctDNA Biomarker for Response to Colorectal Cancer Therapy (GlobeNewswire)
P=NA | N=48 | "Clinical Genomics...announced a new publication from researchers at the prestigious Flinders Centre for Innovation in Cancer, Flinders Medical Center in Adelaide, S. Australia on COLVERA...This observational study provides further data to support the use of COLVERA to monitor patients throughout their CRC journey; Quantification of methylation levels of COLVERA correlates to tumor burden at diagnosis"
Observational data
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COLVERA™
over3years
[VIRTUAL] Clinical performance of methylation-based liquid biopsy test COLVERA after optimization of test interpretation rules. (ASCO 2021)
This change in the COLVERA interpretation rule resulted in optimized clinical specificity with minimal impact on sensitivity . For an assay intended to aid in surveillance and early recurrence detection, improved accuracy allows the physician to have increased confidence in making actionable decisions based on test result, including further imaging or treatment.
Clinical • Liquid biopsy
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IKZF1 (IKAROS Family Zinc Finger 1) • BCAT1 (Branched Chain Amino Acid Transaminase 1 )
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COLVERA™
4years
Evaluation of Circulating Tumor DNA for Methylated BCAT1 and IKZF1 to Detect Recurrence of Stage II/Stage III Colorectal Cancer (CRC). (PubMed, Cancer Epidemiol Biomarkers Prev)
This prospective study showed that COLVERA ( a two-gene ctDNA assay) was more sensitive for detection of recurrence in a cohort of patients undergoing surveillance after definitive therapy for stages II and III CRC.
Journal
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IKZF1 (IKAROS Family Zinc Finger 1) • CEACAM5 (CEA Cell Adhesion Molecule 5) • BCAT1 (Branched Chain Amino Acid Transaminase 1 )
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COLVERA™
4years
Oxaliplatin-associated sarcoid-like reaction masquerading as recurrent colon cancer. (PubMed, BMJ Case Rep)
Subsequently the rare diagnosis of a sarcoidosis-like reaction from oxaliplatin-based chemotherapy was made. Repeat imaging after 3 months showed resolution of the hepatosplenic lesions and lymphadenopathy, alike.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
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COLVERA™
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oxaliplatin
4years
A randomised controlled trial testing provision of fecal and blood test options on participation for colorectal cancer screening. (PubMed, Cancer Prev Res (Phila))
In a population familiar with FIT-screening, provision of a blood test either as a rescue of FIT non-participants or as an up-front choice did not increase overall participation. This might reflect a lack of awareness of the blood test for screening compared to FIT.
Journal • Clinical
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COLVERA™