News Briefs 

Fluoresentric received the “Most Promising Company” award at this month’s Molecular Med Tri-Con 2015, after coming in first place among presenters pitching their company’s value proposition to a panel of industry leaders at the Inaugural Swimming with the Sharks competition. (For more on the conference, see “Reporter’s Notebook: Molecular Medicine Tri Conference 2015.”) Presenters at the competition were judged on clinical utility, investor readiness, and healthcare impact. Fluorosentric presented its XCR technology for nucleic acid amplification, designed to amplify and detect DNA and RNA targets within approximately five minutes. XCR instruments are portable, highly multiplexed, and feature simple sample prep with low cost reagents. Press release 

The Association for Molecular Pathology (AMP) released an updated position statement on direct-to-consumer genetic testing. AMP supports the sale of clinically meaningful tests directly to the public, as long as certain conditions are met. AMP opposes direct access to genetic tests that are performed for the purpose of selling additional health‐related products or services and do not provide clinically meaningful or actionable information. For recreational or novelty genetic testing, such as ancestry testing, AMP maintains a neutral position. The position statement comes shortly after 23andMe received the first-ever FDA approval for a direct-to-consumer genetic test. (See, “23andMe Receives FDA Authorization, Will Not Share Test Results.”) The full AMP position statement is available online. 

Peter D. Meldrum, President and CEO of Myriad Genetics, notified the company of his decision to retire at the end of the fiscal year on June 30, 2015. The decision comes shortly after Myriad announced that it would stop fighting court battles to prevent competitors from testing for BRCA mutations that confer a high risk of breast cancer. (See, “Humbled Myriad Caves on BRCA Patents.”) Myriad’s board of directors has unanimously elected Mark C. Capone, currently president of Myriad Genetic Laboratories, Inc., as Mr. Meldrum's successor. Press release 

TrialReach raised a $13.5 million Series B financing round led by Smedvig Capital with participation from existing investors Amadeus Capital Partners and Octopus Investments. The U.K.-based TrialReach plans to use the funds to support the growth of its clinical trial platform and expansion into the U.S. The TrialReach platform is designed to aggregate and structure all clinical trial listings worldwide, so that patients can be matched with the specific trials for which they may be eligible. In addition, the platform gives trial sponsors the opportunity to describe trials and patient criteria in a non-clinical manner for the benefit of prospective participants. Press release 

Lifecode, a next-generation-sequencing based molecular diagnostics company, received accreditation from the College of American Pathologists. Lifecode also announced that it had raised a previously undisclosed $20.5 million A-Round led by Sequoia Capital, The Mayo Clinic, and Mayo Ventures. Lifecode is the new incarnation of Silicon Valley Biosystems, which originally offered a diagnostic service based on in silico interpretation of genomic data. (See, “SV Bio Relaunched as Lifecode, Maker of LDTs.”) Press release 

Personalis signed a 66-month lease for more than 31,000 square feet at Menlo Business Park in Menlo Park, California. Personalis recently completed a $33 million Series C financing round led by Lightspeed Venture Partners, bringing the company’s total venture capital raised to date to $75 million. Personalis’ CLIA-licensed, CAP-accredited laboratory provides researchers and clinicians with DNA sequencing and interpretation of human exomes and genomes. Press release 

Quintiles announced it is working with the National Football League (NFL) to track player injuries and understand trends in injury occurrence. Quintiles and the NFL have been working together since 2011, when the Quintiles epidemiology group was tasked with designing a new application that would modernize the league’s injury surveillance system.  The NFL recently signed a five-year agreement with Quintiles to continue and expand upon its Injury Surveillance and Analytics (ISA) service, integrated with the NFL’s newly implemented league-wide electronic medical record (EMR) system. Quintiles is evaluating a variety of risk factors for sports injuries, including issues relating to rules, equipment and types of surface. Press release 

N-of-One, Inc., became a Silver Partner in Oracle PartnerNetwork (OPN) Specialized program. As a Silver Level member, N-of-One will integrate access to its clinical interpretation solutions with the Oracle Health Sciences Translational Research Center, which aggregates omics data and data from electronic health records to identify biomarkers for drug discovery and clinical development. Users of Oracle’s TRC can now use N-of-One’s clinical interpretation and analysis of next-generation sequencing and companion diagnostic test results in cancer cases for patient-specific profiles. Press release 

The Inova Translational Medicine Institute has joined the network of academic medical centers and hospital systems using PierianDx’s genetic testing software and services. Inova Translational Medicine Institute is working with PierianDx to provide more personalized diagnosis to its cancer patients by classifying, interpreting and reporting on genes in the Life AmpliSeq Tumor assay. Press release 

New Products 

Premaitha Health received CE mark approval for the IONA test, the first CE-marked in vitro diagnostic product for non-invasive prenatal testing (NIPT). Premaitha is now the only company authorized by the European Regulatory agencies to sell a product that allows laboratories to offer NIPT services. Previously, pregnant women in Europe could only access NIPT via the private testing market provided by service laboratories, which involves sending a blood sample to a lab in the USA or China. The IONA test uses next-generation sequencing of cell-free fetal DNA to estimate the risk of a fetus having Down’s syndrome, Edwards’ syndrome and Patau’s syndrome, and features a standardised workflow that can quickly be implemented into clinical laboratories. Press release 

RainDance Technologies launched the ThunderBolts Next-Generation Sequencing (NGS) Target Enrichment System. The ThunderBolts System allows researchers to rapidly detect and analyze somatic mutations from liquid biopsy samples (circulating tumor DNA) or FFPE (formalin-fixed Paraffin-Embedded) tissue samples. It features pre-validated gene panels for profiling solid tumors and hematological cancers, as well as options to create custom gene panels. The ThunderBolts System detects tumor mutations with frequencies as low as one percent, starting with as little as 10 ng of amplifiable DNA. Press release 

Millennium Health added three new genes to its Millennium PGT (pharmacogenetic testing) to help clinicians prescribe the right medication for patients requiring mental health treatments. The three new genes offered are DRD2 and HTR2C, pertaining to antipsychotics, and HLA-B*15:02, relevant to anticonvulsants. Millennium Health’s genetic tests, which look at up to 14 genes, can be applied to medications in chronic pain, mental health, addiction and cardiovascular disease. Millennium Health also launched Destination Well, an online tool offering customers information about pharmacogenetics. Press release 

MedNet Solutions, a global life sciences technology company specializing in clinical study management systems, added new features to its iMedNet Partner Program. The program, which previously offered full sales support and prospective customer referrals, will now also include a dedicated MedNet “Operational Owner” for each Partner, direct involvement in defining and previewing future iMedNet functionality, and price savings of up to 40%. Press release