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CureSeq to Offer Rapid NGS Tumor Profiling Services; Conducting Clinical Trials with Chinese Partners

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This article has been updated with additional information from CureSeq.

NEW YORK (GenomeWeb) – CureSeq of Brisbane, California is gearing up to offer targeted next-gen sequencing-based tumor profiling services that it said will be fast and affordable. The company, a spinout from the University of California, San Francisco, has been selling reagent kits for FFPE DNA extraction and three NGS cancer panels and is currently waiting for CLIA certification of its laboratory.

Last month, the firm also won class I approval for its three cancer panels from the China Food and Drug Administration, and is collaborating with several medical centers in China on clinical trials to obtain class III approval for its tests from the CFDA.

CureSeq was founded in early 2014 by Il-Jin Kim, an assistant professor of surgery at UCSF and the director of the Applied Genomics Thoracic Oncology Laboratory. Kim's team developed three patent-pending technologies that the company licenses exclusively from UCSF and employs in its products and services. A graduate of UCSF's QB3 incubator, CureSeq is located in Brisbane near the San Francisco Airport and has almost 20 employees. The firm is funded by a group of undisclosed private investors and has no current plans to raise additional private funding.

According to Vikki Friedman, CureSeq's global vice president of sales and marketing, the company's mission is to make NGS-based oncology testing more affordable and faster. The turnaround time for its tests will be 48 hours, starting from DNA extraction to a report with actionable mutations, she said.

As it is waiting to obtain CLIA certification for its laboratory, which will enable it to offer comprehensive testing services, the company has been selling research-use-only DNA extraction and targeted NGS cancer panels for laboratories to perform their own tumor sequencing. The panel kits include data analysis services that use the company's proprietary software. Right now, the panels are for use with Thermo Fisher's Ion PGM only, but CureSeq is working on a version for the Illumina MiSeq that it expects to launch later this year. The company is selling its kits directly in North America, and through distributors in Southeast Asia and in China. It is in discussions with potential distributors in the UK, Italy, Spain, and Sweden.

CureSeq's FFPE UltraRapid DNA Extraction kit, which has a list price of $200 for 50 samples, allows users to extract DNA from a single FFPE slide within 15 minutes — less material than is required by competing methods, according to Friedman. This is important, she said, because oftentimes tumor material is only available in limited quantities, or the quality is low. A typical slide yields between several hundred nanograms and a couple of micrograms of DNA, which is compatible with a variety of downstream analysis methods, including qPCR, Sanger sequencing, and NGS.

The company's three NGS panel kits, called NextDay Seq, focus on actionable genes for different cancer types. The kits have a list price of $100 per sample, which includes data analysis. The lung and colon cancer panels each cover seven genes, while the Pan Cancer panel covers hotspot mutations in 27 genes. CureSeq also offers the colon cancer panel under a different name — GIST, for gastrointestinal stromal tumor — because some insurance companies will reimburse tests based on cancer type, Friedman said. Later this year, CureSeq also plans to come out with a panel for the BRCA 1 and 2 genes.

The reason the company's panels are comparatively narrow — Foundation Medicine's FoundationOne test, for example, comprises 315 genes — is that CureSeq's clinical collaborators requested smaller panels, in part because they are more likely to be reimbursed by insurance. "In the clinical space, the feedback is 'less is better,' to focus on a specific disease of origin," Friedman said.

CureSeq analyzes sequence data generated by customers of its panels for actionable mutations, using its own software program, called DanPA, which yields results within about 10 minutes. The program can pick up mutations down to a frequency of 3 percent and produces fewer false positives than other programs the company has tested, Kim said. The firm also uses a PCR-based chemistry that is different from other panel amplification or capture methods to amplify the target genes in its panels.

As the company is awaiting CLIA certification, it has been partnering with hospital, industry, and academic laboratories that run the Ion PGM for pilot projects in order to obtain feedback on the DNA extraction kit and to fine-tune its panel content.

Once CLIA-certified, CureSeq will likely offer its panels as lab-developed tests in the US, after conducting its own clinical trials. Friedman said the company has access to several thousand patient samples through a US collaborator for such trials.

In China, in partnership with Beijing ACCB Biotech, a developer of cancer molecular diagnostics, CureSeq submitted its three NextDay Seq panels to the CFDA as class I tests last year. Last month, the agency approved the kits, which Kim said are the first CFDA-approved NGS panels for cancer. ACCB already has several CFDA-approved single-gene cancer mutation detection kits on the market.

Friedman explained that class I approval applies to general reagent kits, whereas class III approval is for products with probes for specific genes. To obtain class III approval for its three panels, which would change how they can be used but not their content, CureSeq is currently testing them in clinical trials in collaboration with seven major medical centers and hospitals in Shanghai and Beijing and has already tested more than 2,000 patient samples. The trials are comparing different methods for accurately detecting mutations in clinical samples, she said.

In the meantime, CureSeq and some of its Chinese collaborators have submitted studies on lung cancer and colon cancer that involve the NextDay Seq panels to journals for publication, which the firm expects to come out in the near future. In addition, one Chinese collaborator plans to present a poster at the International Association for the Study of Lung Cancer's Symposium World Conference on Lung Cancer in Denver in September.

CureSeq expects to compete with other providers of NGS-based tumor profiling tests or services, including Foundation Medicine, which offers the FoundationOne test, and Thermo Fisher Scientific, which sells the Oncomine panel for the Ion PGM.

In the short term, the company plans to increase distribution of its kits in different parts of the world and to "get the CureSeq name out there," according to Friedman. Longer term, CureSeq is considering partnering with a larger company and is in discussions "with a couple of key players," she said.

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