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With 130M US Lives Under Contract for Verifi, Illumina to Expand NIPT Abroad through Tech Transfer

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Illumina has 130 million lives under contract for its Verifi non-invasive prenatal test in the US and plans to expand NIPT testing on its sequencing platforms to other countries by transferring the technology to clinical labs.

A year ago, Illumina gained access to the Verifi test when it acquired Verinata Health, which had previously signed a collaboration agreement with PerkinElmer to serve as its exclusive commercial partner in the US. At the time, Verinata said that the PerkinElmer deal provided an opportunity to "extend the Verifi prenatal test to the over 160 million people who are currently part of PerkinElmer's contracted managed care network."

Vance Vanier, Illumina's vice president of reproductive and genetic health marketing, told Clinical Sequencing News recently that over the last year and a half, the company has been able to get 130 million lives in the US under contract.

By comparison, Sequenom said last month that it currently has 113 million lives under contract "with a growing number of payor contracts, including two national payors."

Coverage by and contracts with a health insurance organization are "very different categories" Vanier said – while coverage means a health plan considers a test no longer experimental but medically necessary, it does not automatically mean it will pay for the test. That, as well as the amount of payment, is determined through contracting.

Sequencing-based NIPT has been somewhat unusual for a new test, he said, because it is offered by four different companies in the US – Sequenom, Illumina, Ariosa Diagnostics, and Natera. Several health plans chose to contract with only two of the four competitors, "so the contracting piece became its own competitive battlefield among the four companies," he said.

"As the years go on and companies have more time to lobby health plans, perhaps more and more NIPT companies [will] come under contract," said Vanier, who was Verinata's president prior to the acquisition by Illumina. "But at least for the first year and a half, there are actually very big differences between the companies and who has which plans under contract."

Unlike some of its competitors, Illumina has not made public how many Verifi tests it has conducted, but Vanier said that the company has been "extremely pleased with the results over the last year and a half." As previously reported, Illumina plans to submit the Verifi test on the HiSeq 2500 platform to the FDA for clearance before the end of the year.

This year, NIPT testing companies are widely anticipated to release clinical data from average-risk women, opening the door to wider adoption of the technology. A clinical study on an average-risk population using the Verifi assay has already been accepted by a "top-tier" journal, Vanier said, and is expected to be published in the first half of this year.

"It will be a repeat of what happened a couple of years ago when companies came out with their high-risk clinical publications," he said. "We are going to see a wealth of data for average-risk patients coming out on the Illumina platform this year."

Sequenom said last month that it plans to switch to a different platform that will allow for lower-cost NIPT testing, saying it has explored "several different platforms and several different technologies." But Vanier claimed it will be difficult for a new platform to become established because it is lacking clinical data. "No other platform has large-scale clinical validation trials that have been conducted on them," he said. "Only the Illumina platform does to date."

Taking NIPT abroad

Going forward, Illumina plans to expand NIPT testing on its sequencing platforms abroad by helping clinical labs establish the assay technology.

"We think the story of NIPT is going to take a new chapter in the next year or two as more and more labs in Central and South America, in Asia, and in Europe get the opportunity to do the testing themselves," Vanier said.

He said that many countries, especially in Europe, would prefer to do NIPT testing locally rather than ship samples to the US for testing, and countries like France do not permit prenatal samples to be sent abroad.

Also, as NIPT moves from high-risk to average-risk pregnancies in the future, it will become logistically impossible to ship millions of samples abroad. "It's got to be done down the street," he said.

Over the next couple of years, Illumina plans to offer clinical labs in other countries a "turnkey bundled solution" that includes a sequencing platform, reagents, and a license to the assay. "By the end of 2014, I expect that you will see labs abroad on a variety of Illumina platforms starting to run NIPT tests," he said, including the HiSeq and the recently launched NextSeq.

Illumina's NIPT technology transfer is not necessarily tied to the Verifi test, though. "Abroad, our real focus is to enable NIPT on the Illumina platform, period, regardless of whose assay it's going to be with," Vanier said. "As long as it's a high-quality assay where we have confidence that it's going to have a very low false-positive and false-negative rate …. we're extremely supportive, as long as people run NIPT on the Illumina platform."

"Customers will absolutely have a choice about whose assay they want to use," he said, although there might be price advantages in purchasing a bundle that includes the platform, reagents, and the Verifi assay.

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