Illumina (NSDQ:ILMN) and Loxo Oncology (NSDQ:LOXO) are teaming up to develop a multi-gene panel for broad tumor profiling. The two companies ultimately hope to sell a next-gen sequencing-based companion diagnostic that will boast a pan-cancer indication. Illumina and Loxo plan to seek approval for a version of Illumina’s TruSight Tumor 170 test as a companion […]
Diagnostics
Companies push back against allegations of FCA violations over excess at-home blood testing
A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]
Manufacturing fault prompts BD to recall blood collection tubes
Becton Dickinson‘s (NYSE: BDX) life sciences division issued a recall last month for some of its blood collection tubes, citing a manufacturing flaw that resulted in devices without sufficient additive. The company explained that an internal investigation found that Vacutainer Citrate Plus tubes with too little additive led to falsely-shortened clotting time and could impact patient […]
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
Curetis wins FDA nod for respiratory infection diagnostic system
Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge. Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any […]
Myriad’s breast cancer diagnostic wins approval in Japan
Myriad Genetics (NSDQ:MYGN) subsidiary Myriad Genetics Laboratories said today that the Japanese Ministry of Health, Labor & Welfare approved its Bracanalysis Diagnostic System to be used with Lynparza – a breast cancer drug marketed by AstraZeneca (NYSE:AZN) and Merck (NYSE:MRK). Lynparza is a PARP inhibitor designed to target deficiencies in DNA damage response pathways. AstraZeneca and Merck […]
Foundation Medicine launches genomic profiling test for solid tumors
Foundation Medicine (NSDQ:FMI) today launched the first FDA-approved comprehensive genomic profiling assay for all solid tumors in the U.S. The test, FoundationOne CDx, is designed to detect specific genomic alterations and help doctors make personalized treatment decisions for their patients. The assay looks for genomic changes in 324 genes that are known to promote cancer […]
This new technology could help surgeons clear out leftover cancer cells
In some instances, as many as 30% of patients need repeat surgeries get rid of cancerous cells initially left behind. The team from Lumicell wants to change that — and improve outcomes for cancer patients. [Image by MDO art director Matthew Claney] After his wife died of breast cancer in 2003, David Lee stepped away from […]
Medtech stories we missed this week: March 23, 2018
From Medizone’s evaluation deal to Advantis Medical Imaging getting CE Mark approval, here are medtech stories we missed this week but thought were still worth mentioning. 1. Medizone inks AsepticSure evaluation deal with commercial cleaning products maker Innovasource Medizone announced in a March 22 press release that it has signed a product evaluation agreement with Innovasource. […]
BD finds chemical from blood collection tube interferes with Magellen lead test
Studies conducted by Becton Dickinson (NYSE: BDX) found that a chemical present in its Vacutainer blood collection tubes interfered with lead tests made by Magellan Diagnostics. The FDA first warned consumers in May of 2017 that Magellan’s lead tests may provide inaccurate results when used with blood drawn from the vein and held in BD’s blood collection […]