Oct 05, 2015
NEW YORK (GenomeWeb) – Strand Life Sciences is aiming to position its 152-gene cancer sequencing test for solid tumors as a tool that can be used early on in a patient's disease in order to inform first-line therapy.
The company launched a 48-gene version of the StrandAdvantage test in the US in April, but has since expanded it to 152 genes in order to boost the clinical utility to about 83 percent, from around 65 percent. The company plans to publish a validation study of its test in a peer-reviewed journal in the near future.
In addition, the key distinguishing feature is that within eight days, the company will return a standard of care report that includes genes recommended for screening by the National Comprehensive Cancer Network, as well as information on chemotherapy pharmacogenetics and immunohistochemistry test results, according to global president and CEO Scott Storrer.
The company's headquarters are in Bangalore, India, where it operates a diagnostic laboratory, the Strand Center for Genomics and Personalized Medicine. Strand made its entry into the US earlier this year when it opened a CLIA-certified laboratory in Aurora, Colorado. Since then, Storrer said, the US-based lab has grown from six to 20 employees. It was initially running its StrandAdvantage test on its three Illumina MiSeq instruments, but now also operates two Illumina HiSeq 2500s.
The StrandAdvantage test has a list price of $4,000. On a self-pay basis, the test costs $2,800. Strand also has a financial assistance program.
The eight-day standard of care report "provides back to oncologists a handful of key information that they can use when making first-line decisions," Storrer told GenomeWeb.
Although the 152-gene NGS test is a pan-cancer test, the initial standard of care report is broken down by the patient's cancer tissue type for breast, lung, and colon cancer.
For each tumor type, Strand will report a different set of genes and IHC markers. For instance, for breast cancer patients, the standard of care will include sequencing results from 11 genes and 10 IHC markers. The 11 genes include ones that are specific to breast cancer, like ERBB2, as well as the gene DPYD, mutations to which indicate that the drug capcetabine, which is approved for breast and colon cancer, is likely to cause severe averse reactions.
That initial standard of care report is "good enough to give to doctors so that they can start the patient on an FDA-approved drug," Storrer said. Then, between seven to 12 days later, Strand returns the full report on all genes.
Storrer said that feedback on the test has been positive. Oncologists like the "bundling of IHC, chemotherapy dosage information, and the eight NCCN genes," he said. "And eight days is early enough to make first-line treatment decisions."
Another advantage of the faster turnaround time, Storrer added, is that insurance companies are most likely to approve changes to treatment within the first 30 to 45 days of treatment. Storrer said that the 30- to 45-day window is a cost-benefit issue for insurers. Payors "want to make sure from day one that patients are on the right therapy because survival goes down the longer the patient is on a drug," he said. If, six months into treatment, the oncologist wants to switch to another drug, it may mean the patient is not responding well. So, payors want to know "how healthy is the patient to be able to adapt to the new drug and the new drug change?"
Already, Storrer said, he has heard from several oncologists that have received results indicating a change in therapy that "if the results would have been given a month later, the drug would not have been approved."
In addition, Storrer said, because the standard of care report includes information about chemotherapy dosage, patients are more likely receive the optimum dosage right away, so that by the time full test results are returned, there has been some progress. If the full test results indicate a clinical trial for a targeted treatment, because the patient has received the correct chemo dosage initially, Storrer said, the individual is more likely to be healthy enough to enroll in that clinical trial.
Currently, Storrer said, the way most oncologists order NGS-based cancer tests is after a patient has stopped responding to first-line therapies. There are many practical reasons oncologists use NGS-based tests in this fashion. The tests are still relatively new to oncologists and they often do not know how to use the information. The tests are not always covered by insurance. For many cancers, there is already pretty good standard of care treatment, and the NGS-based tests are not always fast enough to provide actionable results. Often, even in the case where the tests do point to a potential effective treatment, it is for a drug not approved in the patient's tissue type.
However, Storrer said that by running NGS tests earlier, at diagnosis, they can be more effective. The oncologists that have been ordering StrandAdvantage are typically ordering it for patients who are new to their practice, Storrer said, whether those are patients being diagnosed for the first time or patients who have switched oncologists.
Payors are also often reimbursing for the test. "It's still a struggle," Storrer said, and on a case-by-case basis, but he said it helps that the company's Medicare Administrative Contractor is Novitas, which has issued favorable guidelines regarding NGS-based tests. In addition, the NCCN genes help in some cases with reimbursement. The test still has to be justifiable to get approved, Storrer said.
The company is also launching a clinical trial in India, where it has a diagnostics laboratory — the Strand Center for Genomics and Personalized Medicine — and a relationship with Apollo Healthcare. The study will run around 18 months and will compare standard of care versus the firm's StrandAdvantage NGS test in 300 patients.
The company is also working on two new products — a hematological cancer test and a liquid biopsy assay — both of which the company plans to launch in 2016. Storrer said the liquid biopsy assay would initially be developed as a monitoring tool, rather than as a replacement for solid tumor NGS-based tests. The specificity and clinical utility for liquid biopsies as a means for early diagnosis is "not there yet," he said, "but as a monitoring tool, it's a real win."