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In Brief This Week: Gen-Probe; Caliper, GenMark; Bruker; Meridian; Sigma-Aldrich; Almac Diagnostics; Corning; SDIX; Cellay

NEW YORK (GenomeWeb News) – Gen-Probe said this week that the US Food and Drug Administration has informed the firm that it has concluded that a panel review is no longer necessary for review of the firm's Progensa PCA3 assay. The firm had filed a Premarket Approval Application with the FDA in August 2010 and previously had been told that the test would have to be reviewed by the Immunology panel of the agency's Medical Devices Advisory Committee. In a filing with the US Securities and Exchange Commission this week the firm said that it "expects to work interactively with FDA to address outstanding issues" related to the assay.


Caliper Life Sciences said in a quarterly filing with the SEC this week that it is in discussions with GenMark Diagnostics regarding a potential licensing agreement for certain Caliper patents. The firms extended a prior agreement reached in late February to Feb. 24, 2012, to discuss a license. At the time of the earlier agreement, GenMark had withdrawn a suit it filed against Caliper.

Caliper has since been acquired by PerkinElmer.


Bruker disclosed in a filing with the SEC this week that it paid a total consideration of $3.8 million for its acquisition of Michrom Bioresources in April. The firm hadn't previously disclosed the purchase price.


The board of directors of Meridian Bioscience this week declared a quarterly cash dividend of $.19 per share for the fourth quarter. The dividend is payable Dec. 1 to shareholders of record on Nov. 21.


Sigma-Aldrich this week said that its board of directors has declared a quarterly dividend of $.18 per share. The dividend is payable on Dec. 15 to shareholders of record on Dec. 1.


Almac Diagnostics has published in the Journal of Clinical Oncology an article detailing the development and validation of the genetic signature being used in its test for stage II colon cancer recurrence. The study was conducted by Almac Diagnostics researchers including Paul Harkin, president and managing director of the diagnostic business unit and a professor of molecular oncology at Queens University Belfast.

The researchers developed the signature from a balanced set of 73 patients with recurrent disease and 142 patients with no recurrence within five years of surgery. They came up with a 634-probe set signature that identified high-risk patients with a hazard ratio of 2.62. In an independent validation set of 144 samples, the signature identified high-risk patients with a hazard ratio of 2.53.

"[T]o our knowledge, we are the first investigators to develop and validate a robust prognostic DNA microarray signature for stage II colon cancer from FFPE stored tumor tissue," the researchers wrote. "We now plan a further retrospective validation of the test in a large cohort of stage II colon cancer samples collected as part of a clinical trial."


Corning has opened a new manufacturing and distribution facility for its Corning Life Sciences business in China's Yangtze River Delta. The facility will produce a variety of labware products.


SDIX has reached an agreement to sell the assets of its water quality division to Modern Water for $4.5 million. The Newark, Del.-based firm said that the divestiture will enable it to focus on its core life sciences business.


Cellay said that the Michigan Institute of Urology will perform a clinical trial on the firm's Same Day OligoFISH probe panel for detecting chromosomal abnormalities in prostate cells. The non-invasive test uses cells obtained from a urine sample following a digital rectal exam. St. Clair Shores, Mich.-based Cellay intends to include the data from the trial in the Premarket Approval Application it intends to file with the FDA.


In Brief This Week is a Friday column containing news items that our readers may have missed during the week.

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