SAN FRANCISCO (GenomeWeb) – Natera said this week that it has launched a research-use-only pan-cancer circulating tumor DNA assay for academic and biopharmaceutical customers, and will offer it through its CLIA lab next year initially as a way to monitor patients for disease recurrence and later as a way to determine whether patients will benefit from chemotherapy.
The launch of the ctDNA assay, Signatera, is a "critical first step in our oncology strategy," Natera CEO Matt Rabinowitz said during a conference call discussing the firm's second quarter performance.
In addition, Rabinowitz said that recently launched products in its core business of women's reproductive health — the single-gene NIPT Vistara and cord blood banking service Evercord — are being received well and helping to engage with customers from pre-pregnancy through after birth. As part of this strategy to be essentially a one-stop shop for reproductive health, one focus over the last year has been on coupling its carrier screening test Horizon and its NIPT Panorama—an effort that Rabinowitz said has started to pay off, evidenced by the 63 percent growth in Horizon sales and by the increase in attachment rate of Horizon and Panorama to more than 36 percent from 24 percent when the firm first began the effort at the end of 2015.
In April, results from the so-called TRACERx study were published in the journal Nature and demonstrated early results of Natera's ctDNA assay, demonstrating both its ability to predict relapse in post-operative lung cancer patients an average of 70 days prior to imaging-based diagnosis.
Rabinowitz said that Natera plans to expand its collaboration with the TRACERx researchers, led by Charles Swanton, a professor at the Francis Crick Institute, to demonstrate the ctDNA assay's ability to predict response to adjuvant therapy. In patients with early-stage non-small cell lung cancer, physicians have to decide whether to put patients on adjuvant chemotherapy after surgery. "While the data suggests that less than 5 percent of these patients actually benefit from chemotherapy, physicians generally do not know which patients are likely to benefit," Rabinowitz said.
Aside from lung cancer, launching Signatera as an RUO assay would help build evidence of the test's utility in other cancer types, Rabinowitz said. He added that the company is currently in discussions with partners who have access to more than 3,000 samples in six different cancer indications, including lung, breast, ovarian, bladder, colorectal, and kidney cancers. Such access to patient samples "are crucial for validation," he said and would enable clinical trials that would be "risky and expensive for us to run ourselves."
Rabinowitz said the firm plans to work with its partners to validate Signatera on the 3,000-odd samples throughout the rest of the year and will leverage the data generated from those collaborations to make the case for reimbursement when it launches it clinically.
Rabinowitz added that Natera plans to focus Signatera on detecting minimal residual disease detection, recurrence monitoring and treatment response monitoring. He estimated that the MRD and recurrence monitoring market is around $12 billion in the US alone.
Vistara and Evercord
Earlier this year, Natera launched Vistara and Evercord. Vistara, a targeted NIPT that that searchers for pathogenic de novo mutations in 30 genes, was made available on a limited basis earlier this year to some maternal fetal medicine specialists and key opinion leaders, but is now marketed by Natera more broadly. During this week's conference call, COO Steve Chapman said that the early results of the beta launch have been encouraging. Eight positive calls have been made, two of which have been confirmed with invasive testing. Confirmatory invasive testing is still underway for the other six cases.
"We're managing the roll out carefully," Rabinowitz said, "making sure people know how to use it."
In addition, Chapman said that the genes tested for on Vistara, which are associated with severe skeletal, cardiac, and neurological disorders, each already have molecular pathology codes to submit to insurance companies for reimbursement. So, the company plans to initially use those CPT codes, but once test volumes increase it would likely apply for a code specific to Vistara.
Natera also launched its cord blood and tissue banking service Evercord this year in partnership with Bloodworks Northwest. Rabinowitz reiterated that one of the goals of offering Evercord is to enable the company to transition into the market of newborn sequencing for disease risk prediction.
Chapman added that the Evercord product will also give Natera a foothold into the consumer genomics market. "As genetic testing evolves and becomes more consumer driven, we'll be positioned to offer more tests to patients," he said. And, rather than "spending huge amounts of money" on advertising and marketing to consumers, demand is coming from customers when they log into the patient portal.
Rabinowitz added that Evercord would also serve as a "foray into offering more extensive genetic testing." Although he declined to disclose specific products the company planned to offer, he envisioned eventually sequencing exomes and whole genomes of newborns from samples submitted through Evercord, which could then be used from birth through adulthood to guide health decisions.