Abionic will conduct all premarket process requirements for the test, while Genentech will fund the clinical and regulatory costs associated with the test.
The San Francisco-based microbial genomics firm will sell off its product lines, testing labs, IP, and data within the next three months.
Clinical applications grew 11 percent driven by 34 percent growth in the molecular biology segment, including a 31 percent spike in FilmArray product sales.
Sysmex alleges multiple Beckman Coulter analyzers of infringing two patents covering technology for sensing blood or fluid samples.
The combined firm will be based in Gaithersburg, Maryland and will focus on infectious disease diagnostics and antimicrobial resistance prediction services.
Cytek said that the approval places the company on a path to offering a complete spectral flow cytometry solution — including instruments and reagents — to customers in China.
The group notes the importance of lab CLIA certification, clear test reports, and clinical validity support for test claims in the literature, guidelines, and FDA labels.
The firm said it anticipates using the loan proceeds to fund its pursuit of corporate priorities, including broadening its product portfolio and geographic reach.
The company announced its European subsidiary priced an offering of €6.20 billion ($6.83 billion) in senior notes to fund part of its purchase of GE's Biopharma business.
The company reported $10.7 million in total revenues for the quarter and said test report volume for its DecisionDx-Melanoma test grew 27 percent.
A European study, published today in NEJM, used a POC, PCR-based system to perform CYP2C19 genotyping to guide platelet inhibitor therapy.
The diagnostics company announced it has entered a memorandum of understanding with Orot[+] to expand distribution of Todos' blood tests into Japan.
The German firm said that IB10 Sphingotec DPP3 is the first CE-IVD-marked point-of-care biomarker test that can quantify DPP3 blood plasma levels.
The company, founded earlier this year, is developing a technology for the detection of low-frequency genetic mutations for diagnostic applications.
The genetic testing firm has entered into an equity distribution agreement with Piper Jaffray to offer up to $30 million in stocks, with an initial offering of $22.5 million.
Of the 27 companies in the index, 14 firms' stocks were down, while 13 companies' share prices increased.
The new test would rapidly screen patient samples to determine whether biotin levels are present that could throw off the accuracy of other diagnostic tests.
The company is developing a test to predict the risk of a melanoma patient's cancer metastasizing in lymph nodes without the need for biopsy.
The startup holds an exclusive license from Johns Hopkins University and intends to launch its test in time for World Malaria Day in April 2020.
Get the latest news from Biovica, Invitae, and Agilent Technologies for the week of 8/30/19.
The firm replaced an existing $4 billion credit facility with a $5 billion one, and entered into a new $5 billion revolving credit facility.
The cancer immunotherapy regimen and companion diagnostic test will be available in Europe for patients with triple-negative breast cancer who express PD-L1.
For the six-month period ended June 30, the molecular diagnostic company's revenues fell to $10.9 million from $17.2 million in H1 2018.
The platform is designed to isolate exosomes from blood, then release their extracellular RNA cargo for analysis as biomarkers for diseases including cancer.
The disclosure comes less than a week after the company said that it was out of compliance with the Nasdaq's minimum shareholder equity requirement.