NEW YORK (GenomeWeb) – Natera's new cord blood and tissue banking service, Evercord, which it plans to launch in the second quarter of this year, will eventually enable the firm to move into the whole-genome newborn screening market, the firm said this week.
During a conference call discussing its fourth quarter and full year 2016 performance and in a follow-up interview, Natera discussed its plans for the service and provided an update on its noninvasive prenatal screening and oncology businesses, including new products it is developing in those areas.
Earlier this month, Natera announced that it planned a second quarter launch of Evercord, a commercial offering that allows expecting parents to collect, store, and retrieve their newborn's cord blood and tissue for therapeutic use.
The product is a "natural extension" of Natera's existing reproductive health business that will enable it to leverage existing customers as well as to "engage with patients from pregnancy through birth," Natera CEO Matthew Rabinowitz said during the conference call.
In addition, it will serve as a bridge into a new market — whole-genome sequencing of newborns to predict disease susceptibility and guide health decisions over the long term, he said.
Currently, cord blood is approved to treat around 75 conditions, and the probability for acquiring one of those conditions is one in 217, Rabinowitz said in an interview. In addition, there are around 300 ongoing clinical trials for cord blood or tissue-based therapeutics from diseases ranging from intellectual disability, congenital heart defects, stroke, and type 1 diabetes.
Of those 75 conditions for which cord blood can currently be used for treatment, Natera's carrier screening test, Horizon, screens for 35. As such, Horizon and Evercord will work well together to identify families up front who could benefit by banking their child's cord blood, Rabinowitz said. He added that the firm will also consider expanding the Horizon panel to include more of the conditions for which cord blood can be used to treat.
Natera will partner with Bloodworks Northwest, a Seattle-based blood banking center for the service. Bloodworks Northwest will perform the testing and processing and will cryopreserve samples.
Rabinowitz said that Natera could leverage its existing sales and marketing team to expand into cord blood testing. Natera already markets its other products to the Ob/Gyn market, and Evercord "would be an additional value-added service," Rabinowitz said.
In addition, he said, the company interacts with patients through its patient portal, where patients can schedule genetic counseling appointments, access test results, and manage their interactions with the company. The company can leverage that existing resource to also enable patients to sign up for Evercord. "The fact that we interact closely with Ob/Gyns and patients enables us to offer a compelling product without having to do broad-scale blanket marketing," Rabinowitz said.
Natera has not disclosed pricing for Evercord, but said it will be in line with competitors: approximately $1,700 to process cord blood or $2,700 to process cord blood and tissue, as well as annual storage fees of $150 and $350 for cord blood and cord blood and tissue, respectively.
Over time, the Evercord service will enable Natera to move into the newborn screening market, Rabinowitz said. Initially, he said the company would develop a next-generation sequencing-based newborn screening panel that covers many of the diseases currently tested for on the firm's prenatal panels like chromosomal aneuploidies and microdeletion syndromes, as well as disorders on its Horizon carrier screening panel.
But, eventually, it plans to offer whole-genome sequencing as a newborn screen, Rabinowitz said. He did not provide a timeline for when the firm would launch such a service, but estimated that over the next five to 10 years, whole-genome sequencing at birth would be common. There is already evidence that for some disorders, for instance, the 22q deletion syndrome, babies who are diagnosed at birth can be treated immediately and avoid some of the more severe impacts. Calcium supplements are one intervention that when taken early can avoid some of the cognitive impairments associated with 22q microdeletion syndrome, Rabinowitz said.
But, aside from diagnosing disorders at birth, whole-genome sequencing will provide information that can guide health decisions throughout the person's entire life, Rabinowitz said.
"By combining the cord blood service with genetic testing, we are putting ourselves in a position to be able to move quickly toward offering whole-genome analysis," he said.
Aside from Evercord, Natera also plans to launch a noninvasive prenatal test for a broad range of severe disorders that include cardiovascular and neurologic conditions.
Meanwhile, Natera continues to make progress in getting reimbursed for its tests, though it still struggles with reimbursement for average-risk pregnancies and microdeletion testing. Recently, the Centers for Medicare & Medicaid Services issued CPT codes priced at $802 each for chromosomal aneuploidy and microdeletion NIPT.
The price "establishes a benchmark for negotiating with private payors," Rabinowitz said. Nonetheless, he said that the firm estimates, based on the reimbursement rate so far in the first quarter 2017, that this year 38,000 microdeletion tests per quarter may not be reimbursed and 25,000 average-risk Panorama tests per quarter may not reimbursed.
Currently, more than 40 health plans encompassing more than 100 million lives cover NIPT for all women regardless of risk, Rabinowitz said. Those health plans include Cigna, Anthem, and most Blue Cross Blue Shield plans. "This coverage level shows that we have absolutely made the right bet in driving low-risk NIPT market share and that the plans still holding out will follow this trend," he said. In fact, the company anticipates that Q1 2017 will be a record quarter in terms of test volume.
Natera also continues to experience pricing pressure and as such has been focusing on reducing its cost of goods sold. Rabinowitz noted during the call that Natera aims to reduce the COGS of Panorama to the mid- to low-$200s.
A key step toward hitting that benchmark was the launch of version 3 of the test in January, which added the 22q microdeletion analysis. Previously, Panorama included chromosomal aneuploidy analysis, but analyzed a suite of microdeletions in a separate panel. However, about 80 percent of microdeletion orders are for the 22q microdeletion only, Rabinowitz said. Previously, the firm would run the full panel, but report back only the 22q microdeletion. By including that syndrome on the aneuploidy panel, testing will be more efficient, he said.
As previously reported, Natera is expanding a collaboration in oncology with Cancer Research UK. Last year, Charles Swanton, lead investigator of the TRACERx lung cancer study, which is evaluating Natera's technology for analyzing circulating tumor DNA, presented early results from 50 patients. Rabinowitz said that preliminary results from the next 50 patients who ultimately relapsed showed that Natera's technology could identify relapse four to six months before it was detected by traditional methods. He added that these results have been submitted for publication in a peer reviewed journal.
"Our vision is that physicians will monitor cancer patients for relapse using our cell-free DNA test in combination with regular scans and will start treating patients immediately upon molecular relapse," he said.
Rabinowitz added that the firm is now expanding its research into other cancers. Later this year it plans to launch a commercial service across several cancer types, an RUO assay that will analyze tumor load and monitor residual disease and recurrence. After completing validation studies later this year or early next year, the firm will offer the service through its CLIA-certified laboratory.