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NIPT Developer Premaitha Provides Update on Test Development

NEW YORK (GenomeWeb) – Molecular diagnostics company Premaitha today provided an update on the development and planned launch of its sequencing-based non-invasive prenatal in vitro diagnostic test to estimate the risk of Down syndrome and other genetic disorders.

The Manchester, UK-based company became listed on the AIM platform of the London Stock Exchange this summer, following a reverse takeover by investment firm ViaLogy during which it raised £7.2 million ($11.3 million) from institutional and other investors.

As part of a statement released to recap its financial results for seven months beginning March 1 and ending Sept. 30, the company reported a total comprehensive loss of £3.7 million, which included a non-cash loss of £1.2 million related to the acquisition and reflected preparations for the launch and commercialization of its test, called Iona.

Premaitha said that in accordance with the European in vitro diagnostics directive, it has submitted technical files to a notified body, and expects to receive the CE mark for Iona in January. It plans to launch the test in the first quarter of 2015, initially in the EU.

The test "is designed to allow clinical laboratories, even without a background in DNA analysis technology, to offer [NIPT], thereby ensuring broad uptake and access to pregnant women," according to the company.

Premaitha is working on the final verification of the analysis software, anticipated to happen in January, a step that "is not expected to affect the launch timing of the Iona test."

The company has assessed the Iona test in 351 samples, where it correctly identified all affected samples with sufficient fetal DNA. "Further clinical studies are now ongoing to confirm the test performance prior to launch, and these will be completed prior to launch of the product with publication of the results to follow," Premaitha said.

The company has placed an order for the first commercial batch of Iona test reagents with its suppliers, which it expects to be delivered before the end of December.

It recently opened a customer training and technical support facility, a function that "will expand further" in 2015.

Premaitha's chief commercial officer, Peter Collins, formerly vice president and head of diagnostics at GlaxoSmithKline, has been recruiting a sales and marketing team and "further appointments are planned to strengthen the sales outreach in central Europe, and to expand the technical product specialist team in Manchester," according to the firm.

As of September 30, Premaitha had £5.2 million in cash and cash equivalents.