ClearID is a state-of-the-art test that augments the power of genetic sequencing by molecularly characterizing tumor DNA obtained from whole blood to provide physicians with actionable information on their patients with advanced breast cancer.Thanks to Cynvenio Biosystems Inc., detecting cancer through a simple blood draw is no longer just a theory. Cynvenio is clinical diagnostics company transforming the treatment and management of cancer through the molecular characterization of tumor cells isolated from whole blood. Their approach to cancer assessment has the potential to advance treatment on multiple fronts, including clinical oncology, patient care, and clinical trial management. Cynvenio and Product Development Technologies (PDT) worked through many unique challenges to bring this revolutionary technology to market. Cynvenio is currently making the platforms available to cancer research centers and hospitals around the country.

Leveraging its proprietary LiquidBiopsy technology, which detects the presence of cancer cells circulating in blood with incredible accuracy, Cynvenio recently launched two distinct product offerings.

LiquidBiopsy is a standard blood draw to discover cancer-associated DNA mutations that may present in an individual’s bloodstream. LiquidBiopsy is intended for pharma clinical trials, where longitudinal patient monitoring improves trial efficiency and lowers costs.

ClearID (launched in early 2014) is a state-of-the-art test that augments the power of genetic sequencing by molecularly characterizing tumor DNA obtained from whole blood to provide physicians with actionable information on their patients with advanced breast cancer. Built upon Cynvenio’s proprietary LiquidBiopsy technology, ClearID is designed specifically for breast cancer patients and assesses 50 oncogenes and over 4,500 mutations to identify the molecular characteristics of the each patient’s disease. ClearID is a cornerstone of the personalized medicine movement to genetically match patients with the most effective targeted therapy for their cancer type.

ClearID leverages cutting-edge DNA sequencing to pinpoint mutations that are drivers of disease. It could be the perfect vehicle for recurrence monitoring in high-risk subjects, such as triple negative patients, as it provides a real time window into the patient with no procedural risk and zero false positives.

Cynvenio's LiquidBiopsy platform is a fully automated instrument for rare cell isolation. It delivers high cancer cell recovery from whole blood, and yields violable circulating tumor cells (CTCs) that can be taken off-platform for downstream molecular processing including PCR and deep sequencing. Automated process include sample loading, CTC purification, and two-step immunofluorescence labeling of captured cells.

Physicians are often faced with cases where tissue biopsy is degraded, or the quantity of biopsy material is insufficient for analysis by traditional methods, or it is not practical, or advisable, to harvest another biopsy for clinical reasons. In such circumstances, ClearID’s ability to open a window into the patient through a normal blood draw is extremely valuable. In longitudinal patient monitoring scenarios, ClearID is performed during all stages of the cancer care cycle to measure patients’ response to treatment, detect the emergence of additional mutations, and resistance to therapy.

The full genomic analysis, takes only 7 days.

ClearID results are summarized in a clear genomic report that is tailored to each patient’s tumor and based upon their unique molecular profile. This information includes clinically relevant and up-to-date tumor-related content on actionable mutations contextualized by leading independent clinical practitioners. The ClearID report leverages a database that contains clinical interpretations of hundreds of biomarkers, thousands of variants and their association with drugs, clinical trials and experimental therapies that support physician decision making.

As part of an early release program, Cynvenio is making platforms available to cancer research centers and hospitals around the country. Cynvenio's LiquidBiopsy is also available as a service through the company's federally certified CLIA laboratory, which meets all standards for high complexity testing on human specimens.When Cynvenio first consulted with Product Development Technologies (PDT), a product design and development firm, its prototypical device needed design refinements and engineering development to add functionality, improve the user experience for lab technicians, and address issues of durability, reliability and maintenance for high-throughput use in their CLIA-certified laboratory.

“The development of the LiquidBiopsy platform came with myriad challenges related to usability, functionality of internal electronics, and aesthetics,” said Joel Delman, Los Angeles Creative Director for PDT. “A team of PDT designers, engineers, software programmers and prototyping experts worked closely with the Cynvenio team to address all of these requirements.”

Heat generated by the internal electronics was reduced by designing filters and a ventilation system while the internal layout was refined to enhance the serviceability of the internals. The locking system was improved by pairing it to software, preventing users from unlocking the tray mid-cycle, preventing spillage and contamination or loss of samples.

User-focused elements were a key addition to the refinements. An LED beacon was added that allows operators to view the machine’s status from across the room. Improvements were made to the supply and waste bottle connections, which reduced the likelihood of biohazard or chemical spills. Automation components were integrated to improve test processes and reduce dependence on lab technicians.

Multiple prototypes were created in PDT’s model shop, allowing hands-on design validation testing and ultimately real-world use in Cynvenio’s lab.

“The instruments produced by PDT have been working exceptionally well. They process clinical samples with the speed and accuracy demanded by physicians and expected by patients awaiting their test results,” says Dr. Vahidi.

While other devices have attempted to obtain cancer molecular data from patient blood samples, several important variables have stymied competing approaches in the past, according to Cynvenio scientist Behrad Vahidi. “Low recovery and purity, and not having sufficient quantities of pure enough samples to run molecular analysis are a few of the problem others have not been able to overcome,” he says, adding that Cynvenio is the first company to successfully provide Next Generation Sequencing (NGS) of mutation bearing circulating tumor cells from whole blood (the standard of care relies on cancer cells from surgically obtained tissue biopsy). Unlike its competitors, Cynvenio’s LiquidBiopsy is available both as a platform for in-house use, or as a service provided by the company’s federally certified CLIA laboratory which meets all standards for high complexity testing on human specimens.

At the core of Cynvenio's technology is a microfluidic chip that maximizes recovery by generating large separation forces to capture cancer cells. The chip minimizes non-specific binding of sample to its interior surfaces and allows separation and cell recovery procedures with no sample loss transfer.

Front-ending this process is Cynvenio’s unique patient sample kit which breaks the cold chain because it can travel unrefrigerated for up to four days. The kit is completely self contained and includes Cynvenio’s unique blood stabilizer so the company can service any region served by express courier. Vahidi says that Cynvenio routinely receives samples from as far as Asia, Europe, and the Middle East.

Many experts in genetic oncology see Cynvenio’s approach as the next frontier of cancer treatment, and our client is pleased to be at the forefront. “The molecular revolution is upon us,” says André de Fusco, Cynvenio’s CEO. “I see ClearID being used for every stage of the cancer treatment cycle, from early diagnosis through to targeted treatment and remission. It’s a low risk blood test, and in time it will become a standard method for assessing patients and really understanding how they are responding to treatment. As with most new applications, technology is ahead of practice. Our job now is to close the gap.”