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CureSeq Begins Rollout of RUO Oncology Testing Tools Alongside Diagnostic Service Offering


NEW YORK (GenomeWeb) – Since launching in 2014, CureSeq has been steadily rolling out products and services to improve patient care in oncology. The company most recently released a research-use-only RNA extraction kit, but also plans to launch a next-generation sequencing-based liquid biopsy pan-cancer test and several disease-specific cancer-focused panels by the end of this year.

The company announced last year its plan to offer a DNA extraction kit and library panel kits which it currently sells alongside its bioinformatics software as RUO diagnostic tools. Its bioinformatics software, called DanPA, analyzes sequence data for actionable mutations. CureSeq also uses a PCR-based chemistry that is different from other panel amplification or capture methods to amplify the target genes in its panels.

"Every element about CureSeq technology focuses on the paramount of speed and accuracy to offer the best, most accurate results," Vikki Friedman, CureSeq's global VP of sales and marketing, told GenomeWeb in an email. "Our library kits offer higher yield, are more accurate, and offer better results when sequenced." In addition, "Our bioinformatics executes analysis in 10 minutes per sample, which is ultra rapid reporting results," she noted

The new products that are coming down the pipeline include a liquid biopsy test that will detect cell-free DNA from tumors and act as a pan-cancer diagnostic tool, Friedman said. "We've used a lot of our R&D efforts getting [the liquid biopsy test] released," she said. CureSeq also plans to expand its cancer panel offerings to include a few more disease-specific panels, including mesothelioma, breast cancer, and sarcoma, she added.

In January, the Brisbane, California-based company launched its first CLIA- and CAP-certified laboratory in Vancouver, Washington. "We offer a comprehensive solution [for oncologists]," Friedman said. CureSeq's extraction kits, library panel kits, and bioinformatics software are used in all aspects of the company's services, while next-generation sequencing is performed using Thermo Fisher's Ion Torrent Personal Genome Machine. The involvement of CureSeq's software and products throughout the sample collection, processing, and reporting sets the company apart from other vendors, Friedman added..  

"There is a three-day turnaround time," she said. "Once we receive the samples we are generating reports three days later, clinical reports back to the physicians." This is significantly faster than many labs that currently provide these services, she added.

When thinking about patient care and putting tools in oncologists' hands the rapid turnaround time is key, Friedman said. "Just two weeks ago, we had a case where a female patient had an awful tumor on the side of her neck," she said. It was painful and debilitating. "We had the sample sequenced in less than 48 hours," she said, and the report back to the patient's physician which helped determine a treatment.

"It really was a case that if the woman had waited two weeks, she would have been paralyzed," Friedman said. "It really changed the care and outcome for the patient. That is one of the things that we want to help enable."

Additionally, Brett Robertson was appointed as the company's new CEO earlier this month after serving as chief business officer for Invuity, a medical technology company, for the past six years. Robertson told GenomeWeb that she was "really drawn to the novel technology" that CureSeq had developed and impressed that the company had "accomplished a great deal in a very short period of time."

The company is originally a spinout from Il-Jin Kim's Applied Genomics Thoracic Oncology lab at the University of California, San Francisco. The company does most of the product design, development, and manufacturing for its software, cancer panels, and extraction kits at the Brisbane location, although it has a manufacturing and distribution partnership with Chinese company ACCB Biotech. "We depend on them for their manufacturing of our library panels," Friedman said. ACCB started out as a qPCR product development company, and CureSeq has helped them get into the sequencing technology market, she added.

CureSeq has also collaborated with multiple local Chinese hospitals, work that has produced three peer-reviewed publications over the past year that validate the utility of its cancer diagnostic panels, clinical sequencing services, and tumor profiling services. CureSeq and its collaborators have also published several peer-reviewed studies that show the clinical utility of the company's technologies. Friedman mentioned that several more publications have recently been submitted for review.

One study of note, published in Nature Scientific Reports in February by researchers at the Chinese Academy of Medical Science, validated the CureSeq's lung cancer panel, demonstrating the ability to detect EGFR, KRAS, GRAF, PIK3CA, DDR2, ALK, and PDGFRA gene mutations in 56 lung adenosquamous cell carcinoma patients. They found that the overall mutation rate was approximately 64 percent and that there was a high convergence rate in both adenomatous and squamous components, which the researchers thought suggested monoclonality.

CureSeq has already sequenced 5,000 patients through its Chinese partners using the company's bioinformatics software and sequencing libraries, Friedman said. She expects that the number of patients sequenced will be up to 10,000 by the end of the year.  

"Our team is really expert at resolving and working on the issues inherent to the Ion Torrent technology," Friedman said. "Ion Torrent data is inherently known for issues with false positives, false negatives, and mostly significant issues with homopolymer errors," she clarified in a follow-up email. "Our bioinformatics platform eliminates those errors."

She explains that this is critically important, for instance, when detecting the EGFR exon 19 deletion in lung cancer. CureSeq's informatics suite detects this and other actionable alterations when the Torrent suite software misses them, she added.

The company has also launched a HIPAA-compliant mobile app that is intended for internal use at CureSeq to analyze sequencing data, Friedman said. "The BAM file from the [Personal Genome Machine] goes straight to the mobile app, and then we process the analysis for the final report reviewed by our tumor board and reported by our medical director," she said.

"We are also in the process of putting together a 100,000-patient database," Robertson said. While the company is still discussing how exactly it will use the database, it anticipates it will be an asset for physician usage/clinical trial matching purposes, and possibly for clinical research and targeted drug development, Friedman said. The first phase of the database launch is currently scheduled for the end of this year, she said.