NEW YORK (GenomeWeb) – SeraCare Life Sciences said this week that it has partnered with Navican and Royal Philips on the integration of SeraCare's clinical NGS QC solution to support the roll out of Navican's TheraMap Precision Cancer Care services. The integrated solution merges SeraCare's iQ NGS QC Management software and Philips' IntelliSpace Genomics Platform to automate tracking of all critical genomics workflow QC parameters necessary for monitoring, trending, and reporting on the performance of the TheraMap clinical NGS assay.
"It is no longer sufficient to run just any remnant patient sample as a positive control with today's comprehensive clinical NGS assays," Trevor Brown, VP of clinical genomics at SeraCare Life Sciences, said in a statement. "Labs need to closely monitor all aspects of their QC metrics throughout the entire workflow with quantitative multiplexed standards and track performance over time."
More on the integration of Navican's TheraMap with Philips' IntelliSpace platform can be found here.
Human Longevity Clinical Labs this week received accreditation from the College of American Pathologists. An onsite inspection was part of the accreditation process, the company said. The lab's records and quality control of procedures for the preceding two years were examined, as were laboratory staff qualifications, equipment, facilities, safety programs and record, and overall management.
CareDx this week said it closed its debt refinancing by entering into a credit agreement with Perceptive Advisors, which provided an initial term loan of $15 million. A second tranche of $10 million is available to CareDx at its option over the next 12 months. Proceeds from the initial $15 million tranche will go toward repayment of CareDx's $11.1 million debt obligation to Danske Bank and the former majority shareholders of Allenex. It will also be used for general corporate purposes. Immediately following the repayment of the debt obligations, CareDx will have cash and cash equivalents of about $22 million.
Interpace Diagnostics said this week that it has entered into an agreement with BJC Healthcare, a St. Louis, Missouri-based non-profit, integrated healthcare system. The agreement gives all physicians across the BJC system access to Interpace's ThyGenX and ThyraMIR tests for patients with indeterminate thyroid nodules. The tests combine the rule-in properties of next-generation sequencing of a patient's DNA and RNA with rule-out capabilities of a microRNA classifier to provide physicians with clinically actionable test results.
Boston Scientific this week acquired privately held nVision Medical for an upfront cash payment of $150 million and up to an additional $125 million if potential clinical and commercial milestones are met. nVision has developed a US Food and Drug Administration-cleared device to collect cells from fallopian tubes, which could be developed into a technology for the earlier diagnosis of ovarian cancer, Boston Scientific said. Initial clinical research has suggested that the platform effectively collects cells, which when tested, correlate with a postsurgery definitive diagnosis of ovarian cancer. Boston Scientific said it intends to perform additional clinical research with the device to establish how the fallopian cells it collects can be used to render a diagnosis prior to surgery.
OpGen announced this week that it successfully completed a prospective clinical trial evaluating the impact of using rapid diagnostic testing for identification and treatment of bacteremia and fungemia in hospital intensive care units in Colombia. Following completion of the trial, the firm established a subsidiary, OpGen Colombia, to commercialize its precision medicine products in Colombia and more broadly throughout South America.
MDxHealth's SelectMDx prostate cancer test has been included in the Dutch Diagnosis Related Groups reimbursement system. The DRG reimbursement system was introduced in the Netherlands in 2005 and specifies the reimbursable amounts for 30,000 different treatments. It is regulated by the Dutch Healthcare Authority. Diagnosis and treatment of prostate cancer are reimbursed under the DRG system, MDxHealth said.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the GenomeWeb site.