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In Brief This Week: GE Healthcare, Karolinska Institutet; Illumina; Beckman Coulter, FDA; KeyGene, Donald Danforth Plant Science Center; More

NEW YORK (GenomeWeb News) – GE Healthcare said this week it won a tender offer to exclusively provide next-generation sequencing services to a Karolinksa Institutet research group. The first clinical study using the technology will be directed at identifying mutations and genetic variants associated with metastatic breast cancer. Karolinska will provide patient tissue samples for the study. SeqWright Genomics Services, a subsidiary of GE Healthcare, will provide the sequencing services for analysis of the tissue samples.

Illumina is applying the CE mark to expand the use of the MiSeqDx system in clinical laboratories, which now will be able to develop diagnostic tests using the MiSeqDx Universal Kit on the MiSeqDx system. The kit joins the MiSeqDx Cystic Fibrosis Carrier Screening Assay and MiSeqDx Cystic Fibrosis Diagnostic Assay in Illumina's line of clinical products available for the MiSeqDx. The new functionality of MiSeqDx, will commercialized in "a number" of European countries requiring the CE mark, Illumina said, adding it will begin shipping the instrument starting next month. The company submitted MiSeqDx to the US Food and Drug Administration for 510(k) clearance early this year.

The FDA cleared Beckman Coulter's Access AccuTnl+3 troponin l assay for use on the company's UniCel Dxl series of immunoassay instruments. The 510(k) clearance follows similar clearance for the assay in June by FDA for use on Beckman Coulter's Access 2 immunoassay analyzer. The assay now is cleared for use on all of the company's immunoassay systems. Beckman Coulter's troponin test kits were the source of a regulatory controversy at the firm three years ago that preceded its acquisition by Danaher.

KeyGene and the Donald Danforth Plant Science Center are collaborating to strengthen the plant imaging capabilities at the new Bellwether Phenotyping Facility at the Danforth Center. The partners said the technology "increases the pace of scientific discovery, as well as applications that impact agricultural productivity." The system brings together a temperature control and light-controlled plant growth environment with a conveyer system "to move plants through three instrument chambers."

Sigma-Aldrich was named to the Dow Jones Sustainability Indices, a list of global corporate sustainability leaders. Companies in the DJSI have demonstrated best-in-class performance against numerous sustainability metrics, Sigma-Aldrich said.

Venaxis said the external Data and Safety Monitoring Board has recommended full continuation of the pivotal clinical trial for its CE Marked APPY1 test, a multiple biomarker-based assay for identifying patients at low risk for appendicitis. The company plans to submit the test to the US Food and Drug Administration for clearance early next year. The recommendation by the board, created by Venaxis as part of its pivotal clinical trial for the test, was based upon completion of the second and final futility analysis included in the clinical trial design. The first futility analysis of APPY1 was completed during the summer.

NeoGenomics revised its third quarter earnings and EPS guidance. It now expects revenues of between $16.6 million and $16.9 million, up from an earlier guidance of between $15.8 million and $16.4 million. EPS guidance is now in the range of $.01 and $.02, up from the earlier guidance of flat to $.01.

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