According to the company, this expansion will significantly increase the patient population for targeted therapy and management options for preventive medicine, and it positions Circulogene as one of the most comprehensive molecular diagnostics laboratories in the world.
Recent research has demonstrated that somatic mutations in the BRCA1/2 genes account for a significant percentage of BRCA1/2 mutations in ovarian, breast, prostate and pancreatic cancers.
By adding somatic BRCA1/2 blood testing, Circulogene can now perform paired somatic and germline testing.
The company's paired somatic-germline testing is a single-blood-tube test that can detect acquired (somatic) mutations and inherited (germline) variants in patients with advanced breast, ovarian and other cancers, giving doctors better, more detailed diagnostic information to guide cancer treatment decisions.
For women with recurrent BRCA-associated ovarian cancer, for example, paired somatic-germline testing can determine if they are eligible for treatment with new therapies such as the PARP inhibitors Olaparib and Rucaparib which are FDA approved for patients, whether the mutations detected are germline or somatic.
Circulogene is Clinical Laboratory Improvement Amendments certified and provides biomarker testing for a range of cancers, allowing physicians to match results to specific drugs and clinical trials in just one week.
Using a single tube of blood, Circulogene is able to test for circulating genetic mutations and tumor biomarkers among DNA mutations, RNA fusions, PD-L1 expression and MSI.
Headquartered in Birmingham, Ala., Circulogene is an innovative molecular diagnostics company founded and operated by a team of experienced industry executives and skilled molecular diagnostics scientists.
Applying its proprietary laboratory developed test for cfDNA, cfRNA and MSI liquid biopsies, Circulogene has developed a next-generation sequencing method to provide full genomic load analysis from one standard tube of blood in one week, enabling more accurate data to help clinicians and their patients choose targeted therapies, monitor efficacy and monitor for recurrence.
One tube, one week, complete results. Somatic + Germline; Blood + Tissue + Buccal; DNA + RNA + MSI + PD-L1.
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