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LabCorp Launches NIPT on Illumina System; Agreement with Ariosa Now Non-Exclusive

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NEW YORK (GenomeWeb) – Laboratory Corporation of America said this week that it has developed and launched a noninvasive prenatal test for fetal chromosomal abnormalities. It will offer the test through Integrated Genetics, part of the LabCorp Specialty Group of labs that offer esoteric and genomic testing.

The test, called InformaSeq Prenatal Test, will screen for multiple fetal chromosomal abnormalities and will have testing options for several common sex-related aneuploidies. The test will run on an as of yet unspecified Illumina platform.

LabCorp did not return Clinical Sequencing News' request for additional information. Illumina confirmed that the test would run on one of its next-gen sequencing platforms, but declined to disclose which one.

Earlier this year, the companies signed a multi-year supply agreement for Illumina's NGS instruments and microarray equipment. The deal also gave LabCorp expanded rights to use Illumina's instruments to develop, validate, and market laboratory-developed tests to clinicians in the US and Canada.

In an email, Illumina's Senior Vice President and General Manager of Reproductive and Genetic Health, Tristan Orpin, noted that InformaSeq was not developed as part of Illumina's technology transfer program, which Illumina set up earlier this year to support non-US labs developing their own non-invasive prenatal tests. He also said that InformaSeq had been independently developed and validated.

According to documents on LabCorp's website, InformaSeq has identical performance to Illumina's Verifi NIPT. InformaSeq's sensitivity for trisomy 21, 18, and 13 is greater than 99.9 percent, 97.4 percent, and 87.5 percent, respectively, while specificity is 99.8 percent, 99.6 percent, and greater than 99.9 percent, for T21, T18, and T13, respectively. In addition, the test has a positive predictive value of 0.994 for T21, 0.910 for T18, and 0.843 for T13. As references for these numbers, LabCorp cites validation studies of the Verifi test as well as its own internal correlation data. It has not yet published a study on InformaSeq.

Before launching its own test, LabCorp had been offering Ariosa Diagnostics' Harmony Prenatal Test. The two firms struck a deal in 2012, when Ariosa first launched its test.

Ariosa CEO Ken Song told CSN that LabCorp's decision to develop its own test was not a surprise. At the beginning of the year, the relationship between Ariosa and LabCorp transitioned to a non-exclusive agreement, Song said, and Ariosa hired Dave Mullarkey as president and COO to lead the company's direct sales build-out. That transition has also enabled Ariosa to offer its test more broadly, including to women with both high-risk and average-risk pregnancies, he added.

Song said that, thus far, the transition has gone well, and the company has made progress in securing contracts with insurance companies, noting that Ariosa has around 125 million lives directly under contract.

Song added that for the time being Ariosa's test is still available through LabCorp, although he said that the test is no longer listed on LabCorp's website.

In addition, Song said that Ariosa's international business, which is its "fastest growing segment," would help minimize the impact of potentially no longer having LabCorp market its test in the US. By year's end, he said that more than half of Ariosa's business will be outside of the US. And, even within the US LabCorp is becoming "a smaller portion of our business."

Ariosa previously reported that in the first quarter of the year, its LabCorp partnership accounted for 62 percent of its total revenues of $19.5 million, which was down from 94 percent of its total revenues of $9.6 million in the first quarter of 2013.

InformaSeq is not LabCorp's first entry in the NGS market. The company has also launched a 50-gene cancer panel for tumor analysis, IntelliGen, and CardioSeq, which assesses mutations in genes associated with inherited cardiac disease.

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