IVDT Insight

BD Flu System Receives Regulatory Approval in Japan

Alverix announced that BD (Becton, Dickinson and Company) has received approval from the Japanese Ministry of Health, Labour, and Welfare (MHLW) for the BD Veritor System Flu A+B Test.

The BD Veritor System was developed by BD which collaborated with Alverix for the development of the digital reader which employs Alverix’s near-patient testing platform. The BD Veritor System reader utilizes Alverix’s optoelectronic and signal detection technologies. The BD Veritor System delivers very good positive and negative percent agreement when measured against polymerase chain reaction (PCR) results, the highest sensitivity standard currently available. Following a simple, convenient procedure, objective test results are provided on an easy-to-read digital display. Alverix manufactures and supplies the BD Veritor System reader to BD.

“Following the receipt of 510(k) clearance and CLIA waiver in the United States, this is another important achievement for the...

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February 8th, 2012
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Illumina Rejects Roche Tender Offer

Illumina Inc. announced that its Board of Directors thoroughly reviewed Roche’s unsolicited tender offer with the assistance of its financial and legal advisors and unanimously determined that the $44.50 per share cash offer is grossly inadequate in multiple respects, dramatically undervalues Illumina and is contrary to the best interests of Illumina’s stockholders. Accordingly, the Board recommends that stockholders not tender any of their shares to Roche. The Company filed today a Schedule 14D-9 with SEC detailing the reasons for its rejection.

“It is the Board’s unanimous belief that Roche’s offer dramatically undervalues Illumina and fails to reflect the value of the Company’s unique leadership position and future growth prospects,” said Jay Flatley, President and Chief Executive Officer at Illumina. “Illumina has established itself as the innovation and market leader in tools for genetic analysis, with a proven track...

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February 8th, 2012
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Siemens Partners with ViiV Healthcare, Tocagen on Companion Diagnostics

Siemens Healthcare Diagnostics announced two new companion diagnostics partnerships with pharmaceutical companies ViiV Healthcare and Tocagen, marking a major step for Siemens into this important and fast-growing segment of the IVD market. Both partnerships intend to leverage the clinical trial and commercialization options within Siemens’ CLIA laboratory, as well as Siemens’ established IVD clinical and regulatory expertise.

Siemens’ partnership with ViiV Healthcare will focus on clinical trials related to Celsentri/Selzentry (maraviroc), ViiV Healthcare’s CCR5 co-receptor antagonist for the treatment of CCR5-tropic HIV, followed by potential commercialization of a diagnostics test to assist in patient selection prior to physician treatment decisions, subject to FDA approval.

The Siemens-Tocagen relationship will begin with diagnostic tests to support clinical trials related to Tocagen’s viral gene therapy (Toca 511 & Toca FC) under...

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February 7th, 2012
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Luminex Reports Q4, Full Year 2011 Results

Luminex Corp. announced financial results for the fourth quarter and year ended December 31, 2011. Financial and operating highlights include the following:

-Consolidated fourth quarter 2011 revenue was $47.9 million, a 16% increase over the fourth quarter of 2010; full-year 2011 revenue was $184.3 million, a 30% increase over 2010;

-Fourth quarter 2011 assay sales of $16.4 million grew 77% over the fourth quarter of 2010; full-year 2011 assay revenue was $48.7 million, a 51% increase over 2010 and included a contribution from EraGen Biosciences Inc. that exceeded the high end of expectations for 2011 revenue;

-Fourth quarter 2011 shipments of 307 multiplexing analyzers that included 114 MAGPIX systems, resulted in cumulative life-to-date multiplexing analyzer shipments of 8,678;

-Consolidated gross profit margin of 67.9% for the fourth quarter of 2011, which included the negative impact on gross profit margin resulting from the recording of EraGen...

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February 7th, 2012
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SDIX, BD Diagnostics Announce Collaboration Agreement

SDIX and BD Diagnostics announced the signing of a comprehensive agreement whereby the two companies will collaborate in the development of a microbiology detection solution. The collaboration will combine SDIX’s expertise in development of high performance antibodies with BD’s expertise in diagnostic system development. The collaboration objective is to commercialize a novel system to address market needs for faster time to results and for accurate detection of microorganisms.

“We are excited to be working with a world class organization like BD. This agreement demonstrates our strengths in the design and production of novel, highly specific antibodies and our knowledge and experience in developing antibody based detection systems.”

Under the agreement, SDIX will provide BD Diagnostics access to its proven antibody technology and a non-exclusive license to its patented bacteria phage technology. BD will pay SDIX a $1.25M upfront fee for a...

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February 6th, 2012
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Tecan, Artel Partner to Produce Fully Integrated QC Kit

Tecan has partnered with Artel to offer the QC Kit, a fully integrated performance verification solution for its Freedom EVO liquid handling workstations. The QC Kit incorporates Artel’s proprietary Ratiometric Photometry technology within the Freedom EVO system, enabling collection of precision and accuracy performance data regarding the volumes delivered by every channel of a liquid handling arm, with results fully traceable to international standards. This new tool provides clinical and forensic laboratories a simple and reliable way to meet increasing Quality & Regulatory demand for performance verification.

The QC Kit comprises an Infinite F50 or Infinite 200 PRO microplate reader, a calibrator plate, shaker, barcode scanner and a Freedom EVOware software add-on, plus a range of co­branded consumables, including characterized verification microplates and color dye solutions. All color dye solutions are traceable to international reference standards,...

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February 6th, 2012
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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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