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MDx/CDx Focus: MolecularHealth Opens Lab in Texas; Arno, Leica Ink CDx Deal for Onapristone

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MolecularHealth Opens Texas Lab for Cancer Dx Offering

MolecularHealth this week opened its US headquarters and clinical lab in The Woodlands, Tex.

"The new facilities are an important milestone in the company's path toward the commercialization of its automated genetic diagnostic platform for cancer care in the first quarter of 2014," the company said in a statement.

MolecularHealth, founded in 2004 in Switzerland, originally focused on software analysis and clinical IT work. In recent years, the company established a presence in New York, and late last year it began setting up a next-generation sequencing laboratory in Texas.

The lab will use Illumina's HiSeq platform and perform a targeted panel of more than 500 cancer-linked genes and whole exome sequence patients' tumors.

The 7,000 square feet facility will employ approximately 40 people this year. The lab will be headed by a medical director, and MolecularHealth will hire genetic technologists and client services representatives.

The company recently expanded its US executive team and advisory board.


Arno, Leica Biosystems Ink CDx Deal for Onapristone

Arno Therapeutics and Leica Biosystems have signed a deal to develop a companion test for Arno's personalized cancer drug, onapristone.

Arno is developing onapristone, an anti-progestin hormone blocker, as a treatment for breast and endometrial cancers. Research suggests that onapristone works by hindering the activation of the progesterone receptor (APR), which in turn stops growth of various-types of APR-driven tumors.

The immunohistochemistry-based companion test that Arno is developing with Leica Biosystems will detect APR in tumors that impact women, such as endometrial and breast cancers. "This CDx test will help to identify patients who are APR positive and therefore most likely to respond to treatment with onapristone," the partners said in a statement.

Arno's research has shown that around 40 percent of archived specimens from women with endometrial cancer and 25 percent of archived breast cancer specimens are APR positive. The company's work also suggests that APR may be an important marker for personalized treatment of castration-resistant prostate cancer.

Under the terms of their companion diagnostic development deal, Arno will sponsor and perform clinical trials for onapristone. Meanwhile, Leica Biosystems will be in charge of developing and validating the companion test in time for the launch of a Phase II trial investigating onapristone in endometrial cancer.

The Scan

Review of Approval Process

Stat News reports the Department for Health and Human Services' Office of the Inspector General is to investigate FDA's approval of Biogen's Alzheimer's disease drug.

Not Quite Right

A new analysis has found hundreds of studies with incorrect nucleotide sequences reported in their methods, according to Nature News.

CRISPR and mRNA Together

Time magazine reports on the use of mRNA to deliver CRISPR machinery.

Nature Papers Present Smartphone Platform for DNA Diagnosis of Malaria, Mouse Lines for Epigenomic Editing

In Nature this week: a low-cost tool to detect infectious diseases like malaria, and more.