Navigation Links
Cynvenio Biosystems Receives CLIA Certification for its Genomic Sequencing Laboratory

Westlake Village, CA (PRWEB) July 09, 2013

Cynvenio Biosystems, Inc., a cancer diagnostics company focused on the molecular analysis of tumor biomarkers derived from whole blood, today announced certification from the U.S. Department of Health and Human Services' Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 for its genomic sequencing laboratory in Westlake Village, California. This certification follows receipt of a California State license and allows the company to accept clinical samples from most U.S. states.

“Cynvenio has achieved an enviable level of operational excellence for its LiquidBiopsy service which includes the isolation of circulating tumor cells and their genomic analysis by next generation sequencing,” said Andreas Bakker, Ph.D., vice president of Operations at Cynvenio Biosystems, Inc.

Cynvenio Biosystems achieved California State licensing in April 2013, enabling the company to begin processing clinical samples. The company is currently accepting clinical samples and its LiquidBiopsy genomic profiling service is commercially available for all patients with solid tumors.

CMS manage and conduct inspections of CLIA laboratories as mandated by the Code of Federal Regulations (CFR 42 Part 493.2). The regulation was enacted to ensure consistent, accurate, and reliable clinical test results reporting from laboratories across the country used for the diagnosis, treatment, and/or prognosis of disease in human subjects. CLIA applies to all clinical laboratories operating in the U.S. and its territories and encompasses more than 200,000 clinical testing sites.

About Cynvenio’s LiquidBiopsy

The LiquidBiopsy service ( uses next generation sequencing to analyze tumor cells isolated from whole blood. The clinical information produced by LiquidBiopsy sequencing provides an understanding of the specific molecular pathways that are driving tumor growth. This analysis can help develop individualized treatment strategies earlier in the disease cycle when more options may be available, and can be useful in metastatic disease when tissue samples may no longer be reliable or easily obtainable.

The LiquidBiopsy process starts with Cynvenio’s self-contained 7.5mL blood sample kit which includes collection materials and pre-paid FedEx packaging for return delivery to the processing lab. Significantly, the kit can travel unrefrigerated for up to five days which enables Cynvenio to support international as well as US testing locations.

Upon receipt at the lab the sample is processed by CT-SEQ, a Cynvenio protocol for direct-isolation-to- next-generation-sequencing without whole genome amplification. CT-SEQ evaluates mutations across 50 oncogenes for the presence of over 2100 single point mutations with a sensitivity of 1%. The results are summarized in a genomic report that includes leading-edge, clinically relevant information on current and experimental treatments and diagnostics for each patient's tumor type, based on their specific molecular profile. This report can be a useful decision-support tool for physicians, and since LiquidBiopsy requires only a normal blood draw, it is suitable for longitudinal patient monitoring and complements traditional FFPE tissue sample analysis. The turnaround time for CT-SEQ is typically 7 days from sample receipt. In addition to clinical oncologists, academic and industry researchers will find CT-SEQ useful for biomarker discovery and real-time monitoring of patients in clinical trials.

“Achieving CLIA certification enables us to accept and report on a variety of clinical samples and is a major milestone in our company’s development,” commented André de Fusco, Cynvenio’s CEO. “We are enthusiastic about LiquidBiopsy’s global reach and our ability to support partners worldwide in their fight against cancer.”

About Cynvenio Biosystems, Inc.

Cynvenio Biosystems, Inc. is a molecular diagnostics company dedicated to the early detection and targeted treatment of cancer. Cynvenio has developed and deployed the LiquidBiopsy system to enable realtime monitoring of tumor cell-associated mutations from a simple blood draw. This information may be used by physicians, academic centers, and drug developers to assist in the definition of treatment cycles for individual patients, the selection of patients for drug trials and to monitor patient response at any stage of disease.

Cynvenio’s CLIA service lab is based in Westlake Village, California. To find out more about the company please visit

LiquidBiopsy® is a registered trademark of Cynvenio Biosystems, Inc.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Cynvenio Biosystems to Present Clinical Data on Mutational Analysis of LiquidBiopsy® Tumor Samples at the 2013 ASCO Annual Meeting
2. Ahram Biosystems Announces Launch of the New Economy Model F1-12 of Its Palm PCR Series
3. Aushon BioSystems Appoints Martin Verhoef Chief Executive Officer
4. AyoxxA Biosystems Closes Series A Financing Round
5. Aushon BioSystems and AH diagnostics Sign Distribution Deal for Scandinavia
6. Aushon BioSystems and AH diagnostics unterzeichnen Distributionsvertrag für Skandinavien
7. Lucas Bagnell Varga LLC Secures $17.4 Million Award For Former Applied Biosystems Executives
8. Genesis Biosystems Unveils Innovative Skin Treatment at Esthétique SPA International Trade Show
9. Indigo Biosystems Nominated for Two TechPoint Mira Awards for Technology Excellence and Innovation
10. Indigo Biosystems Among “Best Places to Work” in Indiana
11. Leica Biosystems and Synthon Biopharmaceuticals Partner to Develop a Companion Diagnostic Program for Targeted Cancer Therapies
Post Your Comments:
(Date:11/24/2015)... -- --> --> ... Market by Product & Services (Primer, Probe, Custom Oligos, ... End-User (Research, Pharmaceutical & Biotech, Diagnostic Labs) - Global ... expected to reach USD 1,918.6 Million by 2020 from ... 10.1% during the forecast period. Browse 183 ...
(Date:11/24/2015)... ... 24, 2015 , ... The Academy of Model Aeronautics (AMA), led by its ... as Multirotor Grand Prix, to represent the First–Person View (FPV) racing community. , FPV ... embraced this type of racing and several new model aviation pilots have joined the ...
(Date:11/24/2015)... York , November 24, 2015 ... a recent market research report released by Transparency Market ... to expand at a CAGR of 17.5% during the ... Prenatal Testing Market - Global Industry Analysis, Size, Volume, ... the global non-invasive prenatal testing market to reach a ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris ... today that the remaining 11,000 post-share consolidation (or ... Warrants (the "Series B Warrants") subject to the ... on November 23, 2015, which will result in ... giving effect to the issuance of such shares, ...
Breaking Biology Technology:
(Date:11/9/2015)... DUBLIN , Nov. 09, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Law Enforcement Biometrics Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/4/2015)... ALBANY, New York , November 4, 2015 /PRNewswire/ ... According to a new market report published by Transparency ... Size, Share, Growth, Trends and Forecast 2015 - 2022", ... value of US$ 30.3 bn by 2022. The market ... during the forecast period from 2015 to 2022. Rising ...
(Date:10/29/2015)... Minn. , Oct. 29, 2015   MedNet ... supports the entire spectrum of clinical research, is pleased ... Minnesota High Tech Association (MHTA) as one of only ... in the "Software – Small and Growing" category. The Tekne ... individuals who have shown superior technology innovation and leadership. ...
Breaking Biology News(10 mins):