The company — develops tests for the early detection of cancer and other diseases in whole blood — is targeting C$3.7 million in a private placement financing round.
The latest NYS Department of Health approval expands the company's CT/NG testing to samples from multiple relevant body sites.
The first application of the technology will be for noninvasive prenatal screening followed by cancer liquid biopsy testing.
A Personalized Medicine Coalition-funded study has found that NGS-based testing is moderately cost effective but that access to targeted treatments remains a hurdle.
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.
Last month, the Cyprus-based genetic diagnostics company launched a number of hereditary cancer and somatic tumor sequencing panels, its first tests for oncology.
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.
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.
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.
The partners are working together to advance tests that will identify which cancer patients have Notch activating mutations and fusions.
The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.
The test uses unique PCR chemistries as well as a streamlined sample prep method to detect resistance mutations without DNA extraction.
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 firm's CEO said it is continuing to develop its distributor network to make its tests available in centralized and decentralized settings globally.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.
iCubate said that it now has a comprehensive solution within European markets for the detection of bloodstream bacteria and important resistance markers.