According to the DOJ, the company also accepted a 25-year ban on participating in any federal healthcare program.
Acquired epilepsy is a form of the neurological disorder that results from other conditions such as stroke, infections, and traumatic brain injury.
The Scottish researchers have cofounded ClinSpec Dx to commercialize an infrared spectroscopy platform that they said may enable more precise screening for brain cancer.
Specific Diagnostics said it plans to apply CE marking to the Reveal system next year, followed by submission to the FDA for 510(k) clearance.
ProciseDx anticipates bringing rapid, quantitative point-of-care tests to market in 2020 using Lumiphore's metal luminescent reporter technology.
Chipscreen is developing a small molecule inhibitor of key serine-threonine kinases involved in tumor angiogenesis, cell mitosis, and microenvironment inflammation.
The FDA-cleared panel includes tests for salmonella, Shiga toxin-producing Escherichia coli, Shigella, Campylobacter, and Cryptosporidium.
Qiagen will develop IVDs for use on Illumina's clinical sequencers and reported preliminary Q3 revenue growth of 3 percent at a constant exchange rate.
In one of its partnerships, Gestalt will work to integrate Flagship Bioscience's machine learning tools to enable cancer biomarker detection.
The firm received a notice from Nasdaq on Oct. 4 saying its stock had not met the minimum $1-per-share closing price requirement for 30 consecutive business days.
The company was originally founded as a spinoff from Korean genomic services provider Macrogen to offer direct-to-consumer genomic rare disease screening tests.
The firm hopes to return fewer VUS in its test reports and to accelerate the resolution of uncertain results issued to patients in that past.
Under the agreement, Prometheus will receive an upfront payment of an undisclosed amount and could receive up to $420 million in milestone payments.
The company announced this week the expansion of a genetic testing program for US patients with inherited retinal disease that it has run with partners since 2017.
The firm is conducting clinical trials in preparation for applying for FDA clearance to market its POC instrument and first assay in the first quarter of next year.
Under the contract, which is worth up to $45 million, Selux is developing a technology for automated, high-throughput antimicrobial susceptibility testing.
The assay was developed in partnership with Merck and is intended as a companion diagnostic for that firm's anti-PD-L1 immunotherapy.
The St. Louis-based firm will use the funds to develop its colorectal cancer screening test, which measures eukaryotic RNA isolated from epithelial cells in stool.
The company had previously declared Chapter 11 bankruptcy, which would have enabled it to reorganize to stay afloat and pay its creditors over time.
The firm has a 180-day grace period in which to regain compliance, by maintaining a $1.00 minimum closing bid price for at least 10 consecutive business days.