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News Breaks
July 31, 2014
11:29 EDTLH, BRLI, DGXFDA announces steps to ensure reliable diagnostic test results
The FDA announced that it took "important steps to ensure that certain tests used by health care professionals to help diagnose and treat patients provide accurate, consistent and reliable results." The FDA issued a final guidance on the development, review and approval of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients, the agency said. These tests are commonly used to detect certain types of gene-based cancers. The FDA also is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests, which are designed, manufactured and used within a single laboratory. The agency also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements. Publicly traded laboratory companies include LabCorp (LH), Quest Diagnostics (DGX) and Bio-Reference Labs (BRLI). Reference Link
News For LH;DGX;BRLI From The Last 14 Days
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August 26, 2015
09:15 EDTBRLIOPKO CEO Frost issues letter to shareholders on Bio-Reference deal
OPKO Health (OPK) chairman and CEO Phillip Frost released a letter to shareholders regarding the recently announced acquisition of Bio-Reference Laboratories (BRLI). "The strategy behind the recent Bio-Reference acquisition is twofold. First, it is a business whose revenues and profits have grown consistently since its launch by Dr. Marc Grodman in the 1980's, primarily through organic growth, to become the third largest full service reference laboratory in the United States," the letter reads. "It has built a reputation of innovation with recognized franchises in women's health, cancer and, more recently, genetics, helping physicians worldwide to diagnose rare genetic disorders and to identify special features of a patient's genetic material to select more effective chemotherapy. Second, it provides an infrastructure for marketing and sales that reaches approximately 10M patients a year." The letter adds that the 4Kscore test confirms elevated PSA tests have reduced costs by roughly $1B and, if the costs of downstream treatment interventions are also considered, there could be $2.5B additional annual savings to the U.S. health care system. "Among the many compelling reasons for the acquisition, we believe Bio-Reference will greatly accelerate the commercial success of the 4Kscore test," the letter continues. "Bio-Reference has the capacity to dramatically increase the number of 4Kscore tests done each day. They provide national marketing and distribution with a large client services group and a large dedicated sales force that already have strong relationships with primary care physicians. Bio-Reference has over 1,200 phlebotomists and 180 blood-draw centers around the country that can facilitate patient access. Finally, Bio-Reference has robust billing operations and a seasoned national reimbursement team that participates in almost every major commercial insurance plan. Bio-Reference has the expertise and extensive infrastructure to help make the 4Kscore test the new standard for identifying aggressive prostate cancer in men with a suspicious PSA." To close the letter, Frost wrote, "Given Bio-Reference's historical seasonal trends, we expect the second half of 2015 to show continuing growth in earnings and profits. We further expect that the contributions of Bio-Reference, FineTech and EirGen, will create positive EBITDA, or earnings before interest, income taxes, depreciation and amortization, for OPKO. Finally, we expect to continue to invest in research and development activities which, if successful, will result in ongoing improvement of our financial performance."
August 24, 2015
16:17 EDTLHLabCorp: Covance announces agreement with leading pharmaceutical company
Laboratory Corporation of America Holdings announced that Covance Drug Development has received a multi-year award from a leading pharmaceutical company to use Covance's Xcellerate platform as an exclusive central monitoring solution for their worldwide clinical trials portfolio. This landmark agreement with a top-tier pharmaceutical company for Covance's first-in-kind Software-as-a-Service offering reflects the company's unique technology capabilities, and reinforces its position as an industry innovator and leader in clinical informatics solutions.
08:45 EDTLHLabCorp announces availability of VistaSeq Hereditary Cancer Panel
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August 20, 2015
17:19 EDTBRLIInnospec to replace Bio-Reference Labs in S&P 600 as of 8/21 close
OPKO Health (OPK) is acquiring Bio-Reference Laboratories (BRLI) in a deal that closed August 20.
10:43 EDTBRLIOPKO Health completes acquisition of Bio-Reference Labs
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August 19, 2015
14:35 EDTBRLIBio-Reference Labs to host special shareholder meeting
Special Shareholder Meeting to vote on the proposed merger with OPKO Health will be held in Mahwah, New Jersey on August 20 at 9 am.

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