Navigation Links
Cynvenio Biosystems Receives CLIA Certification for its Genomic Sequencing Laboratory
Date:7/9/2013

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 (http://www.liquidbiopsy.com) 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 http://www.liquidbiopsy.com.

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

Read the full story at http://www.prweb.com/releases/2013/7/prweb10909343.htm.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... 18, 2017  Market Research Future published a half-cooked research report ... to grow at a CAGR of 12% during the period 2016 ... ... the abnormal cell division without any control. These abnormal cells have ... These cancer cells can spread to other parts of the body ...
(Date:1/17/2017)... , Jan. 17, 2017 The ... at a CAGR of around 7.5% over the ... 2025. Some of the prominent trends that the ... incidences of diseases & graft transplant surgeries and ... Material the market is categorized into immunomodulatory biomaterials, ...
(Date:1/17/2017)...  Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) ... and earnings conference call will be broadcast live over ... a.m. Eastern Time.  A news release detailing the quarterly ... a.m. Eastern Time the morning of the conference call. ... via Zimmer Biomet,s Investor Relations website at http://investor.zimmerbiomet.com ...
(Date:1/17/2017)... , Jan. 17, 2017 Research and ... "Molecular Diagnostics - Technologies, Markets and Companies" to ... ... has increased remarkably during the past few years. More than ... molecular diagnostics and 342 of these are profiled in the ...
Breaking Biology Technology:
(Date:1/6/2017)... , Jan. 5, 2017  SomaLogic announced ... "Digital Life Alliance" established by iCarbonX, the ... to build a "Global Digital Health Ecosystem that ... a combination of individual,s biological, behavioral and psychological ... agreement between the companies, SomaLogic will provide proteomics ...
(Date:1/3/2017)... LAS VEGAS , Jan. 3, 2017 ... announced the introduction of Onitor Track, an innovative biometric ... and men, showcasing this month at the 2017 Consumer ... . In the U.S., the World ... affect more than two-thirds of adults who are overweight ...
(Date:12/20/2016)... and GENEVA, Dec, 20, 2016   Valencell ... sensor technology, and STMicroelectronics (NYSE: STM), a ... of electronics applications, announced today the launch of ... for biometric wearables that includes ST,s compact ... Valencell,s Benchmark™ biometric sensor system. Together, SensorTile ...
Breaking Biology News(10 mins):