NEW YORK – PerkinElmer said this week that it is providing its newborn screening assay for Parent Project Muscular Dystrophy's Newborn Screening Pilot for Duchenne Muscular Dystrophy. In December, the US Food and Drug Administration authorized PerkinElmer's GSP Neonatal Creatine Kinase-MM kit for DMD screening in newborns. New York State recently screened the first infant for Duchenne as part of PPMD's Newborn Screening Pilot, PerkinElmer said, adding the company is collaborating with the NYS Department of Health on a two-year project to screen about 100,000 infants using the GSP CK-MM assay. Results from the pilot will provide options for new and early treatments for DMD and provide a framework for other newborn screening programs in the US and elsewhere, the firm said.
ArcherDx announced this week that it has received breakthrough device designation from the FDA for its Personalized Cancer Monitoring technology, a minimally invasive and highly sensitive product intended for the monitoring of early-stage cancer treatment and recurrence surveillance. As part of an ongoing collaboration, investigators in the TRACERx trial are utilizing ArcherDx's technology to detect low-volume minimal residual disease at high levels of sensitivity to help achieve TRACERx's goal of a more personalized approach to developing cancer treatments, the company said.
The FDA has granted breakthrough device designation to Geneoscopy's preventive screening test for colorectal cancer and precancerous adenomas, the firm said this week. The breakthrough devices program expedites the development and prioritizes the review of medical devices that may provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, Geneoscopy said.
Caris Life Sciences said this week that Cedars-Sinai's Samuel Oschin Comprehensive Institute has become the 33rd member of the firm's Precision Oncology Alliance. The alliance is a collaboration of US cancer centers that work together to advance tumor profiling and establish standards of care for molecular testing in oncology.
MBio Diagnostics said this week that it has been awarded two contracts by SRI International. The first contract is for the development of a multimarker blood test for diagnosing human radiation exposure. SRI is partnering with MBio to establish the feasibility of such a test on MBio's LightDeck platform, which incorporates multiplexed cartridges with the firm's fluorescent readers and software to measure up to 50 analytes in one cartridge. The second contract is to assess the feasibility of detecting anthrax infections from biomarkers in human blood samples. MBio declined to disclose the amounts of the contracts. The company is a subcontractor on SRI programs sponsored by the US Biomedical Advanced Research and Development Authority.
NantHealth said this week that it has agreed to sell its connected care assets to Masimo for $47.3 million in cash. The medical device interoperability assets include the DCX device connectivity system (formerly known as DeviceConX), VCX patient vitals software (formerly known as VitalsConX), the HBox connectivity hub, and the Shuttle interoperability cable, the companies said. They expect the deal to close before the end of the first quarter.
Nucleic acid products developer Integrated DNA Technologies (IDT) announced this week that it has expanded a previously established partnership with Sophia Genetics. Now, purchasers of IDT reagents will have access to the Sophia Set-Up Program to support implementation of next-generation sequencing services. IDT will also offer its customers exome-related analytics technology on the Sophia platform, including the forthcoming version 2 of Sophia's xGen Exome Research Panel.
The European Laboratory Initiative on TB, HIV, and Viral Hepatitis (ELI) this week announced priorities for the next two years to improve integrated diagnostic services. They are to develop a strategy to improve drug susceptibility testing for TB across Europe by implementing a comprehensive quality assurance dashboard; introduce the new World Health Organization-recommended algorithm for HIV testing in selected countries; map the capacities of national TB labs to identify resistance to drugs used to treat drug-resistant TB; include a behavioral science approach to ELI's communication strategies to improve acceptance and implementation of its recommendations; develop a people-centric approach to increase access to and use of testing services by key and vulnerable populations; and train personnel to build a regional pool of lab safety advisers based on international standards.
ELI's mandate covers lab diagnostics, testing, and treatment monitoring needs for TB, HIV, and viral hepatitis. Its core members provide independent technical advisory and support to WHO members and partners.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.