IVDT Insight

Signal Genetics Acquires ChipDX, a Prognostic-Cancer-Test Company

Signal Genetics, a privately held predictive-genetic-testing company focused on oncology and headquartered in New York City, announced that it will acquire all assets of ChipDX LLC (New York City), a prognostic-cancer-test company, including patents for prognostic tests in lung, breast, and colon cancers. The announcement appeared on MarketWatch.com.

As part of the transaction, Signal will acquire the BreastGeneDX, ColonGeneDX, and LungGeneDX tests, all of which are in development at ChipDX. Signal 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...

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February 3rd, 2012
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Enzo Life Sciences Sues Roche, Gen-Probe

GenomeWeb Daily News reported that Enzo Life Sciences has filed lawsuits against Roche, Life Technologies, and Gen-Probe, alleging they infringed Enzo's patent pertaining to labeled nucleotides for use as diagnostic tools.

According to GenomeWeb, in the lawsuits filed January 30 in U.S. District Court for the District of Delaware, Enzo claimed that the companies infringed U.S. Patent No. 6,992,180 titled "Oligo- or polynucleotides comprising phosphate-moiety labeled nucleotides" that was issued five years ago to inventors in New York and has been assigned to Enzo.

GenomeWeb reported further that Enzo is seeking damages from each firm as well as preliminary and permanent injunctions against them from further infringing its patent. If the court does not gratn a permanent injunction, Enzo wants to be awarded compulsory ongoing...

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February 2nd, 2012
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Response Genetics Raises $7.8M in Financing

Response Genetics Inc. has entered into purchase agreements with investors to raise more than $7.8 million from the private placement of approximately 5,300,000 newly issued shares of its common stock at a purchase price of $1.50 per share.
New investors accounted for the majority of the financing, while existing investors, as well as board members and senior management, made up the remainder. The signing of the purchase agreements occurred on Wednesday, February 1, 2012. Final closing of the shares is expected to occur on or before Monday, February 6, 2012.
“We are very pleased with this financing,” said Thomas Bologna, recently appointed Chairman and CEO of Response Genetics. “One of the first things we wanted to do was to strengthen our balance sheet, which we’ve accomplished. We plan to use the proceeds to help us move forward in strengthening and building our business.”
-Richard Park

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February 2nd, 2012
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Roche to Nominate Directors at Illumina Annual Meeting

Roche has provided notice to Illumina Inc. that it will nominate a slate of highly qualified, independent candidates for election to Illumina’s Board of Directors and propose certain other matters for the consideration of Illumina’s shareholders at Illumina’s 2012 annual meeting, which, if adopted, would result in Roche-nominated directors comprising a majority of the Illumina board. Roche also named five alternate nominees for election to Illumina’s board.

In addition to the nomination of independent directors to fill the seats of the four directors whose terms of office are scheduled to expire at Illumina’s 2012 annual meeting, Roche will also propose increasing the size of Illumina’s board from nine directors to eleven directors with the resulting vacancies on the board to be filled by candidates nominated by Roche. This approach allows shareholders to elect Roche-nominated directors comprising a majority of Illumina’s board....

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February 1st, 2012
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Pacific Edge Diagnostics to Open U.S. Office

Hershey Center for Applied Research (HCAR) prepares to welcome another international company to its thriving research facility. Based in Dunedin, New Zealand, Pacific Edge Diagnostics Ltd., a developer of cancer diagnostic and prognostic technology, plans to open its first U.S. franchise to market the company's bladder cancer detection test, Cxbladder, to urologists in the United States by the end of the year.

Looking to build a better understanding of the U.S. marketplace, Pacific Edge chose to bring its product to Hershey because of HCAR's direct engagement in nearly every aspect of the company's U.S. commercialization to date.

"HCAR Executive Director, Jack Atchason, and his staff helped us understand the marketplace and the needs of our top prospects," David Darling, CEO of Pacific Edge, said. "His 18 plus years of Biotech/Pharma commercialization experience was a big asset in helping us build key elements of our plan."

"Convincing...

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February 1st, 2012
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Idaho Technology Seeks FDA Clearance for Expanded Respiratory Panel

Idaho Technology Inc. has filed a submission with FDA for 510(k) clearance of five additional respiratory pathogens for its FilmArray Respiratory Panel, a multiplex PCR assay currently FDA cleared for 15 respiratory pathogens. The additional five pathogens are the following: Bordetella pertussis, Chlamydophila pneumoniae, Mycoplasma pneumoniae, Coronavirus 229E, and Coronavirus OC43. There are currently no FDA-cleared assays for these five pathogens. The Bordetella pertussis outbreaks in recent months have highlighted the need for an FDA-cleared test that can rapidly and accurately distinguish viral infections from more serious bacterial illness.

Kirk Ririe, CEO of Idaho Technology, said, “We have been quite pleased with how well the FilmArray system has been received by the clinical laboratory community and by how quickly it is being adopted. We are very excited about the potential addition of these five respiratory pathogens – particularly the bacterial targets...

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January 31st, 2012
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Thermo Fisher Scientific Develops Method To Detect Carbendazim in OJ

Thermo Fisher Scientific Inc. announced that scientists at its global Food Safety Response Center, located in Dreieich, Germany, have developed and internally validated a new method for detecting residue levels of the fungicide carbendazim in oranges and orange juice.

The new carbendazim method was developed in response to the FDA announcement in January that it would test shipments of imported orange juice for the fungicide. Thermo Fisher’s method can detect carbendazim in orange juice to ensure compliance with regulatory requirements.

Speaking at the Food Safety Response Center, Alan Malus, Thermo Fisher executive vice president and president of the Analytical Technologies Group said, “Our team of scientists worked around the clock to develop a method to test orange juice for traces of carbendazim, and we are pleased to provide the industry with an improved method that automates the sample preparation and improves lab productivity.”

The new...

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January 31st, 2012
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Thermo Fisher Scientific PCT Assay Available for Abbott Analyzers

Thermo Fisher Scientific announced an agreement with Abbott Laboratories to make its Procalcitonin (PCT) assay available with Abbott’s immunochemistry analyzers.

The company’s Thermo Scientific B.R.A.H.M.S Procalcitonin (PCT) assay will be available on Abbott’s ARCHITECT i and ci series of immunochemistry analyzers. Abbott’s high-, medium-, and low-volume integrated diagnostic testing solutions leverage software, reagents, and sample carrier to enable labs to standardize lab operations on a single platform. In turn, laboratories are able to optimize processes, minimize errors and reduce result variability, an increasingly important consideration as clinicians rely more heavily on laboratory diagnostics to guide their treatment decisions.

“Earlier diagnosis of sepsis and other healthcare associated infections can significantly lower healthcare costs and, most important, improve patient outcomes,” said Ken Berger, senior vice...

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January 30th, 2012
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Xagenic Closes $10M Financing

Xagenic Inc. announced the close of a Series A financing totaling $10 million. The financing was co-led by CTI Life Sciences Fund (CTI) and the Ontario Emerging Technologies Fund (OETF) with significant participation by QIAGEN NV. The funds will be used to develop a molecular diagnostic testing platform and lead tests designed for use in physician offices, clinics and hospital settings.

Xagenic is a University of Toronto spinout company based in Toronto. This round of financing builds on a $2.2 million seed round raised in 2010, led by MaRS Innovation.

In conjunction with the closing of this financing, Dr. Shermaine Tilley and Richard Meadows, both of CTI, will be joining the Board of Directors. Dr. Shana Kelley will remain on the Board and two independent directors will be named shortly.

"We are delighted to have attracted this strong syndicate of investors and look forward to working with them towards establishing Xagenic as a world leader offering rapid...

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January 30th, 2012
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Roche vs. Illumina: The Drama Intensifies

 

Update: The New York Times' Dealbook blog posted this in-depth look at the loophole in Illumina's organizational documents that is making it possible for Roche to gain the advantage.
 
As we blogged about last week, Roche intends to buy Illumina Inc., an international company headquartered in San Diego that develops and manufactures array-based systems for DNA, RNA, and protein analysis. However, Illumina's Board of Directors appears to be uninterested in Roche’s offer and has failed to negotiate with Roche in any substantive manner, Roche says. Instead, Illumina’s board of directors adopted a shareholder...
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January 27th, 2012
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