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Newly Formed SkylineDx Acquires Array Tests, IP, Other Assets of Defunct Skyline Diagnostics

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SkylineDx has acquired all assets from recently shuttered Skyline Diagnostics and will continue to develop and commercialize the latter's menu of microarray-based tests, BioArray News has learned.

CEO Dharminder Chahal said this week that he and Van Herk Investments bought Skyline Diagnostics' assets, know-how, and IP in August.

Based in Rotterdam, the Netherlands, Van Herk has invested in a number of molecular diagnostics and biotechnology firms, including Agendia, another Dutch company that offers microarray-based tests for cancer.

Chahal did not disclose the terms of the acquisition. He said that a new firm, SkylineDx, has been established to continue Skyline Diagnostics' operations and to bring additional tests to market. In addition, Chahal said that the new company has retained Skyline Diagnostics' "core team."

Skyline Diagnostics was founded in Rotterdam in 2005. It is unclear how much money the company raised to support its programs. The firm had said it raised about $18 million in Dutch government grants, and raised $7.2 million in a series B round in 2010, three years after it closed its series A round, the amount of which was never disclosed.

Before it went bankrupt earlier this year, the company developed two microarray-based tests for blood cancers. Affymetrix manufactures the chips that are used in both assays.

The company's first test, AMLprofiler, relies on cytogenetics, mutation analysis, and expression analysis to subtype patients with acute myeloid leukemia. Skyline Diagnostics obtained CE-IVD marking for the test in 2011, and had been planning a US Food and Drug Administration submission in 2012 (BAN 3/15/2011).

Skyline Diagnostics had offered the test to European clinicians from its laboratory and Chahal said that SkylineDx will continue to offer the test in this manner. The AMLprofiler assay is also available in other countries where European IVD regulations are acknowledged, he said. However, Chahal said that the new company no longer plans to seek FDA clearance for the assay at this time as SkylineDx will not fund a pre-market approval trial.

SkylineDx also will continue to offer Skyline Diagnostics' second test, MMprofiler, a risk stratification and genetic subtyping tool for use in treating multiple myeloma. MMprofiler is now available for research in the EU and the US, Chahal said. He also said that Skyline intends to obtain a CE-IVD marking for MMprofiler next year.

According to Chahal, the company also plans to make MMprofiler available to US clinicians as they have a "strong need" to use its high-risk biomarkers to predict a poor prognosis. He said that the test should be available for clinical use in the US eventually, but did not elaborate.

On its website, SkylineDx also advertises its availability for partnerships with pharmaceutical and diagnostic companies and research institutes. Skyline Diagnostics had disclosed agreements with Janssen Pharmaceuticals and Clavis Pharma in the past (7/26/2011, 9/6/2011). It is unclear whether SkylineDx is continuing these partnerships.

In addition to leading SkylineDx, Chahal is also CEO and co-founder of CardioGenX, a company developing tests and therapeutics for cardiovascular diseases. He has also served as a consultant to Van Herk. The new firm's chief operations officer is Leonie de Best, who was previously manager of operations and quality at Skyline Diagnostics.

SkylineDx's acquisition of Skyline Diagnostics' assets is the second such deal to take place in the past few weeks.

In August, Response Genetics paid $1.35 million to acquire the assets of Pathwork Diagnostics, a company that had developed and launched an Affymetrix-manufactured test for cancer of unknown primary (BAN 8/27/2013).

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