NEW YORK (GenomeWeb) – Natera plans to launch version three of its noninvasive prenatal test Panorama this year, which will include improved detection of the 22q microdeletion syndrome, the company said last week during a conference call discussing its second quarter 2016 performance.
The firm said that it is making progress in reimbursement for Panorama, but that reimbursement for microdeletion testing will decline in the near term.
In addition, CEO Matthew Rabinowitz said that the company is continuing to expand into the areas of transplantation and oncology, including a recently struck collaboration with the University of California, San Francisco to use its technology to identify cell-free DNA markers for kidney transplant rejection and collaborations with more than 12 CROs and other previously announced collaborators to collect matched tissue and plasma samples from individuals at high risk for lung, ovarian, and breast cancer to focus on identifying markers of early-stage disease.
Natera plans to launch V3 of Panorama this year, which will include improved performance for testing of 22q microdeletion and will also reduce the firm's cost of goods sold.
As part of its "first phase of deployment" of the V3 test, Natera plans to launch a new protocol for testing for 22q microdeletion, which should reduce the false-positive rate and increase the positive predictive value, Rabinowitz said.
Improvements will involve the resequencing of samples that are indicated to be high risk in the initial assay, which he said would "reduce the false-positive rate by a factor of three to 0.12 percent, and increase the PPV from 18 percent to above 40 percent" for the 22q microdeletion.
These improvements will help differentiate Natera's offerings from competitors' tests, he said, and also adhere to recent guidelines issued by the American College of Medical Genetics and Genomics on NIPT, which said that labs should provide fetal fraction, PPV, negative predictive value, as well as sensitivity and specificity for each condition screened.
In addition, due to the fact that customers are ordering 22q microdeletion testing more frequently than the entire microdeletion panel that Natera offers, the company will enable 22q microdeletion testing to be included in the initial Panorama assay, rather than as a separate test.
There has been "more shift in our microdeletion business to the 22q-only option," Steve Chapman, Natera senior vice president of commercial operations, said during the call.
There is also a stronger case for reimbursement of the 22q microdeletion, Rabinowitz said, since there are clinically proven interventions that can be initiated early on to improve health outcomes.
The company has now also added microdeletion testing to its Constellation platform, enabling laboratories that license technology from Natera to also license its microdeletion testing methods. Life Labs was Natera's first customer to license microdeletion testing technology through Constellation.
Natera has more than 178 million lives covered under its direct sales channel in the US and more than 200 million lives covered under its US-based direct sales and lab channel.
Chapman said that the company has been transitioning to in-network contracts with many of the large national plans, including United Healthcare, Aetna, and Cigna, and that it is seeing "steady reimbursement in line with negotiated pricing."
Although most payors do not include average-risk pregnancies in their coverage policies for NIPT, Chapman said that the company anticipates that the recent ACMG guidelines, which said that NIPT should be offered to all pregnant women regardless of risk, "will have a positive impact on average-risk NIPT reimbursement and will support our argument when we appeal denied claims."
Aside from reproductive health, Natera is looking to expand into the transplantation and oncology fields, which the company anticipates to be $1.3 billion and $12 billion to $20 billion market opportunities, respectively.
With regards to transplantation, the firm recently struck up a collaboration with UCSF, whereby researchers at UCSF would use Natera's cell-free DNA technology to analyze donor-derived cfDNA from several thousands of samples of patients who have had kidney transplants. The goal is to figure out whether cfDNA can be analyzed noninvasively to identify patients at risk of rejection earlier than conventional methods and improve patient management, Rabinowitz said.
"Collaborations like this let us efficiently expand our test menu," he added.