High sensitivity blood test allows measurement of HER2 over-expression in patients after primary tumor has been removed and tissue biopsy is no longer available - provides novel way to monitor treatment effect and changes in tumor biology over time.
WESTLAKE VILLAGE, CA – August 24, 2017 – Cynvenio Biosystems, Inc., a leader in liquid biopsy testing technology for personalized medicine, today announced the launch of its new ClearID HER2 Expression Test. The new test allows doctors to perform real-time monitoring and analysis of HER2 levels in their patients without using tissue biopsy. Cynvenio’s test is performed from a normal blood draw and is especially suited in cases where tissue biopsy is not possible, for example after a lumpectomy or other resection of the primary tumor.
Over-expression of HER2 occurs in approximately 15–20% of breast cancers and 10–30% of gastric / gastroesophageal cancers and serves as both a prognostic and predictive biomarker. HER2 over-expression has also been observed in other malignancies including ovary, endometrium, bladder, lung, colon, and head and neck.
“We have developed a robust methodology to isolate HER2-positive circulating tumor cells from the peripheral blood and cerebral spinal fluid of breast cancer patients with both early stage and metastatic disease,” said Paul Y. Song, MD, Cynvenio’s Chief Medical Officer. “We also isolate HER2-positive circulating tumor cells in gastric and colon cancer, and we believe this new LiquidBiopsy test provides clinicians with valuable real-time insight into disease response to HER2 targeted therapy.”
In addition to what is known about tumor heterogeneity, studies have found that HER2 status can change during tumor progression. In cases of local and systemic relapse, HER2 status has been shown to switch between positive and negative in up to 25% of patients✝.
“Blood-based testing ensures the treating physician is not misled by tumor heterogeneity or changes in tumor biology over time,” said Pat Whitworth MD, Director, Nashville Breast Center. “Liquid biopsy offers a very practical way to characterize the tumor and monitor treatment effect. For cancers that become HER2 positive during treatment, this technology can detect a clinically meaningful opportunity for effective management.”
The HER2 test leverages Cynvenio’s LiquidBiopsy platform and uses antibodies against EpCAM, TROP2, HER2, and EGFR, delivering ultra-high purity outputs with >95% specificity and sensitivity. The test has a 3-7 day turn-around time and is processed by Cynvenio’s CLIA/CAP laboratory in California. It is also available to all laboratories running Cynvenio’s LiquidBiopsy platform and workflow. Clinicians or scientists interested in ordering the test kit can visit www.clearidmonitoring.com or www.liquidbiopsy.com for more information.
About Cynvenio Biosystems, Inc.
Cynvenio’s LiquidBiopsy® testing technology provides affordable and clinically actionable precision medicine strategies for physicians treating cancer patients. The company’s core offerings include the ClearID® family of blood tests for tumor assessment and patient monitoring, and the LiquidBiopsy® platform and consumables for deployment in third party labs and hospitals. Cynvenio is based in Westlake Village, California. For more information, please visit www.cynvenio.com, www.clearidmonitoring.com, and www.liquidbiopsy.com.
✝Lindstrom et al., J. Clin. Oncology 2012; Wallwiever et al., BMC Cancer 2015.
LiquidBiopsy® and ClearID® are registered trademarks of Cynvenio Biosystems, Inc.