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Aria Diagnostics Raises $52.7M to Commercialize Non-Invasive Trisomy Test

NEW YORK (GenomeWeb News) — Aria Diagnostics said today that it has raised $52.7 million in Series C funding that it will use to commercialize a prenatal test to detect fetal aneuploidies such as trisomy 21.

New investors include Meritech Capital Partners and an undisclosed mutual fund group. Existing investors Venrock and Domain Associates also participated in the round.

Aria also said today that its laboratory in San Jose, Calif., has received initial certification under the Clinical Laboratory Improvement Amendment.

The company is developing a sequencing-based method that analyzes cell-free DNA in maternal blood to detect fetal chromosomal abnormalities.

Aria is currently conducting clinical studies to evaluate the performance of its test. In a study published last week in the journal Prenatal Diagnosis, researchers from the company and the Medical College of Wisconsin reported that the approach "enables highly accurate, cost efficient, and scalable noninvasive fetal aneuploidy assessment."

In the study, researchers used the company’s Digital Analysis of Selected Regions, or DANSR, assay to analyze cell-free DNA from the blood samples of 298 pregnant women with the aim of detecting trisomy 21 and trisomy 18.

The company said in a statement that the technology "was able to correctly distinguish all cases with confirmed fetal abnormalities."

Furthermore, the researchers stated in the paper's abstract that the depth of sequencing required for the test "represents less than 5 percent of that required by massively parallel shotgun sequencing approaches."

Aria faces some competition in the market for sequencing-based noninvasive trisomy testing. Sequenom last October became the first mover in the sector with the launch of its MaterniT21 test, but other companies, including LifeCodexx and Verinata Health, are also developing similar tests.

Aria said today that its method differs from competing offerings because it "is more efficient and selective in analyzing genetic material, which leads to a greater than ten-fold improvement on the sequencing throughput."

The company also faces a thorny intellectual property landscape as it looks to commercialize its test. Sequenom has stated publicly that it holds exclusive rights to the use of circulating cell-free DNA in maternal plasma to diagnose fetal aneuploidies. LifeCodexx holds a license to the Sequenom IP that gives it the right to market its test in Europe.

Aria's test has already attracted the attention of Sequenom's legal team. In a lawsuit filed last month, the company requested a declaratory judgment that its test does not infringe Sequenom's patent.

Aria said in the complaint that it had received a letter from Sequenom's counsel dated Dec. 6 requesting a "detailed explanation" of why its test would not infringe Sequenom's IP.

According to the suit, Aria believes that Sequenom has "misrepresented" the scope of its patent, with the goal of "deterring potential competitors from entering the market and deterring doctors and health care providers from using anyone other than Sequenom."

In the complaint, Aria does not contest Sequenom's exclusive right to the patent, only that Aria's test does not infringe the patent.