LabCorp Enters Definitive Agreement to Acquire Monogram Biosciences

Laboratory Corp of America® Holdings (LabCorp) and Monogram Biosciences Inc announced recently that they have entered into a definitive agreement and plan of merger under which LabCorp will acquire all of the outstanding shares of Monogram in a cash tender offer for $4.55 per share for an implied total equity value of approximately $106.7 million, or a total enterprise value of approximately $155 million at March 31, 2009, including net indebtedness.

“The transaction announced today is a significant step in the execution of LabCorp’s strategy of leadership in personalized medicine,” said David P. King, chairman and CEO of LabCorp. “Monogram Biosciences Inc has an excellent clinical reputation, a market-leading infectious disease test, a market leading companion diagnostic, an exciting technology platform for oncology, and offers LabCorp a substantial growth opportunity. By utilizing LabCorp’s national infrastructure to build on Monogram’s already strong sales, we will advance our leadership in infectious disease and cancer testing, companion diagnostics, and personalized medicine. We look forward to providing improved offerings to both our and Monogram’s current customers.”

Monogram’s proprietary, clinically validated Trofile® assay identifies patients who are eligible for the CCR5 class of HIV drugs and is the widely adopted companion diagnostic for the HIV drug Selzentry®. Monogram’s PhenoSense® and PhenoSense GT® HIV tests measure individual patient viral drug resistance, thereby enabling physicians to design optimal, individualized treatment plans for each patient. PhenoSense and PhenoSense GT are among the most widely used HIV resistance tests in the market. Monogram’s proprietary VeraTag™ technology has been used to develop a sensitive means to assess HER-2 status in tissue samples and has significant potential as a tool to help guide therapy decisions in breast cancer patients. Based on the VeraTag platform, Monogram has multiple tests in development for measuring a variety of protein markers that may have clinical utility to help guide treatment decisions across a broad range of cancer drugs. The potential oncology pipeline associated with this technology is a natural extension of LabCorp’s existing oncology offerings for both clinical trials and commercial clients.

Source: Laboratory Corp of America

NEJM Study Highlights Need for Rapid Strep B Test

A study published in the June 2009 issue of the New England Journal of Medicine concluded that rapid, PCR-based testing at the time of admission for delivery may improve the accuracy of Group B streptococcal (GBS) screening over the normal antepartum testing done at 35 to 37 weeks of gestation. GBS disease is one of the most common infections in the first week following birth and is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia, and meningitis. Transmission of GBS occurs from colonized women to their babies during childbirth.

The article, “Evaluation of Universal Antenatal Screening for Group B Streptococcus,” points out that current US Centers for Disease Control (CDC) guidelines for preventing neonatal GBS disease, which call for culture-based screening of expectant mothers at 35 to 37 weeks of gestation, have helped to reduce incidence of early-onset GBS disease since their implementation in 2002. However, the study also finds that 61.4% of full-term infants born with GBS disease were born to women who had previously screened negative during their 35- to 37-week gestation.

“This revealing study shows clearly that screening for GBS at 35 to 37 weeks gestation leaves many newborns at significant risk of GBS infection, presumably due to either false negative culture results or due to a change in GBS status, from negative to positive, over time,” said David Persing, MD, PhD, Cepheid’s executive vice president, chief medical and technology officer. “As indicated by the study authors, a more accurate way to identify colonization status and target antimicrobial therapy may be to perform a rapid test at or around the time of delivery.”

Cepheid’s Xpert® GBS test is designed to run on a STAT basis, returning positive results in as few as 32 minutes. It is the only in vitro diagnostic test to fully meet current CDC criteria for rapid intrapartum GBS testing. Xpert GBS is also the only PCR-based antepartum and intrapartum GBS test to receive “Moderate Complexity” CLIA categorization by the FDA, enabling health care professionals such as labor and delivery nurses to run the test near-patient—24 hours per day, 365 days per year.

Source: Cepheid

Exosome Diagnostics and DxS Collaborate to Develop Blood-Based Tests for Key Cancer Mutations

Exosome Diagnostics Inc and DxS Ltd announced recently that they will collaborate on the development of blood-based companion diagnostics for key cancer gene mutations, such as KRAS, BRAF, and EGFR. The collaboration will use DxS’ industry leading Scorpions® real-time PCR Mutation Test Kits in conjunction with ExosomeDX’s xOS™ technology, which harvests high-quality nucleic acids from blood exosomes.

The collaboration will initially focus on developing blood-based measurement of KRAS, BRAF, EGFR, and other key mutations for predicting patient response to targeted therapies. Blood-based mutation measurement is particularly valuable in circumstances where tissue bioavailability is limited, such as in lung, pancreatic, and ovarian cancers.

Exosomes are small microvesicles precipitously shed by all solid tumors into blood. They contain virtually the entire cancer tumor transcriptome. In studies, ExosomeDX has identified more than 21,000 mRNA and 1,100 miRNA in circulating-tumor-derived exosomes, all protected in the exosome lipid bilayer from any blood-based RNase. Initial findings were published in the December 2008 issue of Nature Cell Biology.

“There are over 180 companies investigating over 370 different molecular targeted cancer therapies, many of which will require high-quality, molecular companion diagnostics” said James McCullough, CEO of Exosome Diagnostics. “Teaming with the world leader in this space is a critical step in providing a solution for pharmaceutical companies, researchers, and clinicians to measure the key mutations DxS Scorpion probes target directly from blood.”

“Combining the ability to pull high-quality mutations from a simple blood draw with the unparalleled sensitivity and specificity of our Scorpion assays will provide our pharmaceutical and research customers with an ideal solution in personalized medicine” said Dr Stephen Little, CEO of DxS.

Source: Exosome Diagnostics and DxS