Healthcare Industry News:  NSCLC 

Diagnostics Oncology Product Launch

 News Release - June 11, 2015

Personal Genome Diagnostics Launches LungSelect(TM) For Non-Invasive Detection Of Clinically Actionable Mutations In Lung Cancer

LungSelect Identifies Clinically Relevant Somatic Alterations in Non-Small Cell Lung Cancer in Plasma with High Specificity, Eliminating the Need for Biopsy Tissue

PGDx Researcher Dr. Theresa Zhang to Present LungSelect Data at GTCBio's Companion Diagnostics Conference in San Diego


BALTIMORE, June 11, 2015 -- (Healthcare Sales & Marketing Network) -- Personal Genome Diagnostics, Inc. (PGDx), a provider of advanced cancer genome analysis and testing services, today announced the launch of its LungSelect™ product that identifies the most common, clinically actionable genetic alterations in the plasma of non-small cell lung cancer (NSCLC) patients. Theresa Zhang, PhD, PGDx's Vice President of Research Services, will present data on LungSelect at the upcoming GTCBio Companion Diagnostics Conference in San Diego.

In response to the increasing availability of targeted therapies for NSCLC, clinical guidelines recommend molecular testing of relevant genes to identify candidates for targeted therapy. However, an estimated one-third of NSCLC patients lack adequate tissue samples for molecular testing and therefore cannot be considered for the new targeted treatments. The plasma-based LungSelect test enables testing of all NSCLC patients for relevant sequence mutations, insertions and deletions, and genomic rearrangements, including those patients who may have acquired new mutations post-treatment and those with multiple tumor sites.

LungSelect simultaneously identifies somatic sequence mutations and translocations that can be treated with agents already approved by the FDA or that are in clinical trials, including most defined in the NCCN Guidelines®. LungSelect is able to detect sequence mutations and translocations down to 0.02% and 0.1% circulating tumor DNA levels respectively, with sensitivity greater than 90% and positive predictive value greater than 99%. The majority of NSCLC patients with advanced disease have mutations detectable at these circulating tumor DNA levels.

Dr. Zhang commented, "The rapid advances in targeted cancer therapies for treating NSCLC make the availability of LungSelect especially timely. All NSCLC patients will now have the opportunity to be tested to see if new life-extending therapies may be relevant to their cancer, regardless of whether or not tumor tissue is available. PGDx is a pioneer in liquid biopsies for cancer, and we are pleased to offer this informative new test for NSCLC, which is the single largest cause of cancer deaths in the U.S."

The LungSelect test is analyzed in PGDx's CLIA laboratory. Results will be available in approximately two weeks. For more information, visit http://www.mypersonalgenome.com/.

Dr. Zhang will present "Identify Clinically Actionable Sequence Mutations and Translocations in the Plasma of Lung Cancer Patients without Invasive Biopsies," at the Companion Diagnostics Conference on June 12, 2015 at 12:15pm. The conference takes place June 11-12, 2015 in San Diego, CA. For more information, see bio.com/conferences/companion-diagnostics-overview.

About Personal Genome Diagnostics

Personal Genome Diagnostics (PGDx) provides advanced cancer genome analyses to oncology researchers, drug developers, clinicians and patients. The company uses advanced genomic methods and its deep expertise in cancer biology to identify and characterize the unique genomic alterations in tumors. PGDx's proprietary methods for genome sequencing and analysis are complemented by its extensive experience in cancer genomics and clinical oncology. PGDx's CLIA-certified facility provides personalized cancer genome analyses to patients and their physicians. For more information, visit personalgenome.com.


Source: Personal Genome Diagnostics

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