Israel-based software company Medial EarlySign will work with Geisinger's innovation center to develop technologies to predict lower GI and other "high-burden" diseases.
The company had a profit of £3.4 million, or £0.01 per share, for the year compared to a loss of £9.6 million, or £0.03 per share, the previous year.
Five hundred pharmacies will provide information about pharmacogenetic testing to members who have failed one or more antidepressant treatments.
The funding will support a collaboration focused on telomere maintenance and the development of cancer diagnostics based on the company's technology.
One BioMed was spun out of Singapore's Agency for Science, Technology, and Research to develop a point-of-care diagnostic platform for infectious disease.
Based in Austria, EuroLyser develops point-of-care testing devices and kits. ArchiMed also acquired EuroLab, EuroLyser's main distributor.
Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.
Inspirata said that the entity will assist hospitals and universities across Europe with data processing, including inter-institutional processing.
The new list comprises 122 test categories — 46 general IVDs, 69 IVDs for specific diseases, and seven test categories for screening blood donations.
The investment firm also reduced its price target to $30 per share from $37 citing "lower overall conviction" that Myriad would meet its revenue projections.
Under the agreement, Biodesix will use the Thermo Fisher Ion Torrent Oncomine Pan-Cancer Cell-Free Assay to generate data to apply for FDA premarket approval.
Nasdaq told the company that its shares have failed to meet a minimum $1 per share closing price for 30 consecutive days and may face delisting action.
Using a fingerstick, the Mylan HIV Self Test can be completed at home and detects whether HIV antibodies are present in about 15 minutes.
The Elisabeth Severance Prentiss Foundation gift will expand research into the use of saliva to monitor lithium levels in patients with bipolar and other disorders.
The partners are working together to advance tests that will identify which cancer patients have Notch activating mutations and fusions.
The deal, which is initially for five years, also covers the Eurasian Customs Union, with an option for other countries in the area.
The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.
The firm is validating a mild TBI biomarker-based diagnostic kit for use by paramedics, first responders, and other healthcare professionals.
The funding will be used to support clinical validation and expand market access for the firm's endometriosis diagnostic test.
The new guidance is part of MDR and IVDR, which have increased oversight of diagnostics, many of which were self-certified under previous rules.
The antibody, called leronlimab, is a CCR5 antagonist under development by CytoDyn for a variety of indications including HIV and breast cancer.
The firm said its assay is a real-time qPCR test for the direct detection of methicillin-resistant Staphylococcus aureus DNA in nasal swabs.
The FDA approved FoundationOne CDx as a companion diagnostic for olaparib for first-line maintenance therapy in BRCA-mutated advanced ovarian cancer.
The bipartisan legislation would delay the reporting of lab payment data by a year and collect recommendations on improving PAMA payment reporting requirements.