This Week In Diagnostics

IPSOGEN acquires rights for new cancer biomarkers

IPSOGEN SA (Alternext: ALIPS), a majority-owned subsidiary of QIAGEN N.V. (Nasdaq: QGEN), has reported that it has acquired the worldwide exclusive rights to testing for mutations of the IDH1 and IDH2 genes for diagnostic purposes from Baltimore, Maryland-based Personal Genome Diagnostics (PGDx). IDH1 (isocitrate dehydrogenase 1) and IDH2 are enzymes and the mutations in IDH1 and IDH2 genes, discovered in 2008 by the founders of PGDx, are frequently found in brain cancers, including early stage and late-stage gliomas. Subsequent studies have implicated IDH1/IDH2 mutations in acute myelogenous leukemia (AML) and other cancers.

Biomarkers and depression

In a paper published in the journal Molecular Psychiatry, a team including Massachusetts General Hospital (MGH) researchers reports that a test analyzing levels of nine biomarkers accurately distinguished patients diagnosed with depression from control participants without significant false-positive results.  The test developed by Ridge Diagnostics measures levels of nine biomarkers associated with factors such as inflammation, the development and maintenance of neurons, and the interaction between brain structures involved with stress response and other key functions.

Signal Genetics acquires ChipDX

Signal Genetics has reported signing an agreement with New York based ChipDX LLC, under which Signal will acquire all of the assets of ChipDX, including patents for prognostic tests in lung, breast, and colon cancers. As part of the transaction, Signal will acquire BreastGeneDX, ColonGeneDX, and LungGeneDX, all diagnostic and prognostic tests in development by ChipDX. Signal says it believes that these genetic tests represent novel products or improvements over other products currently on the market in these cancer types. Signal will also acquire ChipDX’s web-based interface, which will be used to enhance Signal’s physician web portal and allow for remote interpretation of test algorithms. Ryan VanLaar, Ph.D., CEO and Founder of ChipDX, will join Signal as the Head of BioInformatics. Financial details of the transaction were not disclosed.

Agreement struck to produce custom nucleic acids

Synthetic Genomics, Inc. (SGI) and Integrated DNA Technologies, Inc. (IDT) have jointly announced that they have entered into an agreement to manufacture, market, and commercialize small synthetic gene products. SGI and IDT will work together to construct custom, synthetic, double-stranded nucleic acids up to 5 kb. IDT will use its custom oligonucleotide manufacturing expertise, including its recently launched gBlocks Gene Fragments product line, in combination with SGI’s proprietary technologies to efficiently assemble small gene constructs. The financial details of the agreement were not disclosed.

FDA approves test from Roche

Roche says that the FDA has provided 510(k) clearance to the cobas® CT/NG Test for the detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections in both symptomatic and asymptomatic patients from male urine and self -collected vaginal swabs.  A polymerase chain reaction (PCR)-based multiplex dual probe assay, the test for chlamydia and gonorrhea runs on the automated cobas 4800 System, complementing the cobas HPV (Human Papillomavirus)Test that received FDA approval in April.

Diagnostics industry veteran joins Life Technologies

Ronnie Andrews, former CEO at Clarient and Segment Leader, GE Molecular Diagnostics, has joined Life Technologies as President, Medical Sciences. Mr. Andrews has more than 25 years of experience in the diagnostics industry, including leadership positions at companies such as Abbott Diagnostics and Roche Diagnostics. He will apply his expertise to expand Life’s presence in the diagnostics and personalized medicine space through strategies including short and long term partnerships.

-Peter Winter

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