Precision believes that it has sufficient evidence of the clinical validity of GeneFx Lung from existing and in-process peer-reviewed publications which demonstrate the prognostic power of the test. In order to establish evidence of the clinical utility of GeneFx Lung, Precision is planning to initially commence commercialization of the test through a select group of top-tier clinical and academic institutions to assess the impact of the GeneFx Lung risk determination on physician treatment recommendations and patient care decisions. It is expected that this study will show that GeneFx Lung provides actionable information which affects the decisions of physicians and will provide to insurers compelling evidence of clinical utility. Precision is planning to undertake a broad national commercial roll-out of GeneFx Lung approximately three to six months from their initial focused launch of the test. The adoption and recommendation of the use of GeneFx Lung by these centers of excellence and their key opinion leaders in lung cancer is also expected to increase general awareness, acceptance and adoption of the test.
Presentation of GeneFx Lung Data at ASCO
On June 1, 2013, Precision presented data regarding GeneFx Lung at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The presentation was titled "Performance of a Prognostic Genomic Signature for Early-Stage NSCLC in Matched Fresh Frozen and RNA-Stabilized Tissue" and detailed the successful completion of the previously announced clinical studies to validate the use of GeneFx Lung with tissue preserved by RNAlater®, a molecular fixative.
RNAlater eliminates the need to flash-freeze specimens and to keep specimens frozen throughout storage and transport, a process that is cumbersome and costly and limits test adoption as many laboratories are not equipped to work with frozen specimens. It also eliminates the need for preserving tissue in formalin, which is known to cross-link and degrade the nucleic acids rendering them less suitable for specific downstream molecular applications.
The clinical study was undertaken by Precision Therapeutics of Pittsburgh, Pennsylvania, Almac Diagnostics Ltd. of Craigavon, Northern Ireland and the University Health Network and Princess Margaret Hospital of Toronto, Ontario.
Settlement Agreement for Dismissal of Lawsuit by Signal Genetics LLC and Respira Health LLC
On August 22, 2013, MBI announced that it and Precision had entered into a settlement agreement with Signal Genetics LLC and Respira Health LLC for the dismissal all of Signal and Respira's remaining legal claims made against MBI and Precision in the Supreme Court of the State of New York.
Pursuant to the settlement agreement, within three days of the payment by Precision to Signal and Respira of a certain financial obligation to be made on or by January 5, 2014, Signal and Respira will dismiss and withdraw all of their remaining legal claims made against MBI and Precision.
The terms of the settlement are confidential. As part of MBI and Precision's commercialization agreement, Precision is solely responsible for all financial obligations under the settlement agreement.
Petition by Dissident Shareholders
On August 21, 2013, MBI announced that the petition (the "Petition") filed by certain shareholders of MBI against the company in the British Columbia Supreme Court will be heard by the Court on August 30, 2013. After reviewing and responding to the affidavit evidence filed by the petitioners with the Court, MBI continues to believe that the claims made in the Petition are entirely without merit.
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