Glooko named health tech veteran Russ Johannesson as its new chief executive this month, adding that the diabetes data management company’s former CEO, Rick Altinger, is slated to become EVP of corporate development. Johannesson previously served as the chief operating officer of Sharecare, a digital health and wellness platform. Before that he led sales, marketing and […]
Diagnostics
Bristol-Myers Squibb, Illumina to develop companion diagnostics for immunotherapies
Bristol-Myers Squibb (NYSE:BMY) is joining forces with Illumina (NSDQ:ILMN) to develop and commercialize diagnostic tests to support Bristol’s portfolio of cancer drugs. The companies announced last week that they plan to develop an assay to measure predictive genomic biomarkers, like tumor mutation burden, that could help doctors identify patients that will benefit from Bristol’s immunotherapies. Get the full […]
Confer Health raises $9.5m for fertility diagnostic
Confer Health said today that it raised $9.5 million to support its development of affordable, at-home diagnostic devices featuring interchangeable cartridges, a reusable analyzer and a mobile app. The Boston, Mass.-based company’s first urine-based diagnostic test is designed to help couples conceive by tracking three fertility hormones. Get the full story at our sister site, Drug Delivery […]
Qiagen launches liquid biopsy tests for lung, prostate cancer
Qiagen (NYSE:QGEN) today launched two liquid biopsy panels designed to evaluate circulating tumor cells isolated from a patient’s blood samples. The company’s lung and prostate cancer diagnostic tests will be introduced at the annual meeting of the American Association for Cancer Research in Chicago, according to Qiagen. Get the full story at our sister site, Drug […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant or nonsignificant risk. The agency wrote that sponsor should use the proposed pathway when possible “to reduce administrative burden on sponsors and FDA and to maintain […]
Apple faces patent suit over Apple Watch heart monitor tech
Apple (NSDQ:AAPL) is facing a lawsuit that claims its heart rate sensor infringes on patents from Omni MedSci, according to court documents posted early this month. The Ann Arbor, Mich.-based startup claims the watch infringes on a total of four of its patents which reference laser and light-based technology designed to monitor physiological metrics based around […]
FDA requests more info for TearLab’s eye diagnostic tech
TearLab Corp. (OTC:TEAR) said today that the FDA told the company it needs more information regarding its 510(k) application for the TearLab Discovery platform and test card designed to measure an inflammatory biomarker found in tears. The U.S. regulatory agency specifically took issue with the FDA-cleared predicated that TearLab chose to establish substantial equivalence. Get the […]
This visor-like device could be a defibrillator for stroke
A portable, visor-like device has shown potential for detecting emergent large-vessel occlusion with 92% accuracy in patients who may have had a stroke. The researchers suggest that the diagnostic device could be readily accessible to emergency personnel and in public spaces in the same way a defibrillator is available for treating heart attacks. Researchers and […]
Illumina, Loxo Oncology partner for next-gen pan-cancer companion diagnostics
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 […]
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 […]
This fluorescent dye could create clearer biological imaging
Massachusetts researchers have repurposed a commercially-available dye that has been around since the 1950s to make short-wave infrared easily available for clearer imaging. Fluorescence imaging is often used to visualize biological tissues or blood vessels during reconstructive surgery to see if vessels are connected properly. Currently, researchers use a dye that runs at the near-infrared […]