Shares in Quest Diagnostics (NYSE:DGX) held steady today after the company met earnings expectations on Wall Street but missed analysts’ sales estimates with its first-quarter results. The Secaucus, N.J.-based company posted profits of $177 million, or $1.27 per share, on sales of $1.88 million for the 3 months ended March 31, for bottom-line growth of 7.9% […]
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. “Through our […]
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. Confer added that it is also developing an at-home […]
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. “Our AdnaTest liquid biopsy-based portfolio now offers molecular […]
FDA issues draft guidance for the use of diagnostics in cancer drug trials
The FDA issued draft guidance this week describing a streamlined submission process to determine whether using an in vitro diagnostic in a cancer drug’s clinical trial poses a significant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 […]
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. The company […]
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 […]
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 […]
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