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Strand Life Sciences Opens Colorado CLIA Lab; Launches Tumor Sequencing Test

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NEW YORK (GenomeWeb) – Strand Life Sciences, a genomic software company, opened a CLIA-registered laboratory this week in Aurora, Colo., and has launched a next-generation sequencing-based pan-cancer test dubbed StrandAdvantage.

Strand also has a diagnostics laboratory in Bangalore, India — the Strand Centers for Genomics and Personalized Medicine — and has been offering the StrandAdvantage test through that laboratory for the last three years, but will now market it as a laboratory-developed test to community oncologists in the US.

In addition, the Strand Centers for Genomics and Personalized Medicine in Bangalore also offers an NGS-based test that analyzes germline DNA of 86 genes to assess an individual's cancer predisposition risk, a 196-gene cardiology panel, a 460-gene rare disease test, and a 184-gene retinal dystrophy test.

The company also has a number of ongoing collaborations in the US, including one with El Camino Hospital to establish a Strand Center for Genomics and Personalized Medicine at the Genomic Medicine Institute at El Camino Hospital with the goal of developing NGS-based diagnostics. And last year its subsidiary, Strand Genomics, partnered with BioHealth Innovation to expand the Strand Centers for Genomics and Personalized Medicine into the US.

Concurrent with the company's Colorado opening and US launch of StrandAdvantage, it has hired additional members to its US management team including Scott Storrer as global president, Preveen Ramamoorthy as global head of diagnostics, Harsha Rajasimha as vice president of global business development, Doreen Korba as vice president of global marketing, Caely Cusick as vice president of personalized medicine, and Cheryl Abrantes as manager of client services.

The StrandAdvantage test currently analyzes 48 cancer-related genes on one of the laboratory's three Illumina MiSeq instruments. Around June, the company plans to launch an expanded version of the panel that will run on Illumina's NextSeq system, Storrer, who is also CEO of Strand Genomics, told GenomeWeb.

What sets the test apart, Storrer said, is that the company plans to deliver results on the eight genes recommended for testing by the National Comprehensive Cancer Network within eight days, which will allow physicians to use the results when deciding on a patient's first line of therapy. The full report on all 48 genes will be delivered within 15 days, he added.

"It is the first time that oncologists have the opportunity to use an NGS test for first-line therapy," Storrer said.

Currently, companies like Foundation Medicine, which offers an NGS-based test that sequences more than 200 genes, predominantly market their tests to patients with advanced or metastatic cancer. There are numerous reasons for that, including the fact that there aren't recommendations for such large panel tests and that guidelines do exist for initial treatment for most patients.

The list price for patients who pay out of pocket is $2,800, but Storrer said that the company also accepts insurance. He said that although it is still early, he is optimistic about insurance companies reimbursing for these types of tests. "The insurance companies will be hard pressed to not accept and reimburse for these tests," he said. "It's just a matter of time." He added that the fact that the Centers for Medicare and Medicaid Services have issued codes for NGS panels is a signal that the NGS "world is coming."

Storrer declined to disclose the volume of tests the company runs from its US and India laboratories, nor the labs' capacities. However, he said that its test volumes are following a similar trajectory of other players in the field — doubling year over year.

In addition, he said that approximately 67 percent of patients receive an actionable result, and when the firm launches the expanded version of the test this summer, he said he expects that rate to climb to around 83 percent.

So far, oncologists who have ordered StrandAdvantage have done so for patients with advanced cancers. But Storrer said that the ability of the company to quickly turn around results on the eight genes recommended by the NCCN is driving some oncologists to start ordering the test earlier and use the results to make decisions on initial treatment regimens. "There's enough clinical utility there for an oncologist to begin a treatment plan," he said.

Strand Life Sciences is primarily known as a software company, but over its 15 years of existence and through collaborations with other laboratories, it has built up a curated database of over 200,000 variants. That database essentially prompted the company to examine it to see what value could be extracted from it.

About four years ago, Storrer said, the firm realized that it had "good insight around gene selection for a cancer assay." The team developed the assay and launched it in India. Aside from its two commercial laboratories in Aurora and Bangalore, the company has two additional research and development labs in Bangalore.

The firm is poised to compete in the US against number of other companies that also offer NGS-based cancer tests that are designed to guide treatment, including Foundation Medicine, Molecular Health, and Caris Life Sciences. In addition, many academic laboratories have developed their own panels, like Memorial Sloan Kettering, Washington University, and the Fox Chase Cancer Center.

Nonetheless, Storrer said that because the field is still so new, Strand's main competition will not be with other providers of NGS cancer tests, but with single-gene tests and chemotherapy. A big part of the firm's work will be to make oncologists aware of NGS-based tests that can analyze tens to hundreds of genes in a single go.

Storrer said that although the test is currently being offered as an LDT, the company designed it with an eye toward potential regulation by the US Food and Drug Administration. He said that the company is currently working to bring the Colorado laboratory up to par with the FDA's Quality System Regulation guidelines. In addition, he said that the firm is developing clinical trials that assess cost and efficacy of its test, which will involve working with the FDA on study design.

The company also has other tests in the works, including an NGS panel for hematological malignancies that will launch in 2016 as well as a liquid biopsy test, Storrer said, though he declined to disclose additional details about future products.

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