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The firm will manufacture its Logix Smart mycobacteria tuberculosis assay at its ISO-certified facility in Utah but will not seek FDA approval at this time, it said.
The Dutch multinational is now on track to introduce a kitted version of the assay, which can be run on standard quantitative PCR equipment, by the end of the year.
The company delivered 4,621 billable tests during Q1, and billable testing volume was the highest in a quarter in Fulgent's history.
The team developed their method to facilitate tumor cell movement through the blood-brain barrier for cancer biomarker detection. The method could eventually lead to the detection of brain cancer using a blood test.
PredictImmune's test relies on a 16-marker panel run using quantitative PCR to stratify Crohn's disease and ulcerative colitis patients according to the severity of their illnesses.
Amplidiag CarbaR+MCR detects the main carbapenemase-producing organisms and colistin resistance markers. Novidiag Bacterial GE+ identifies the most common enteric pathogens.
The firms will develop new business opportunities, exchange technical expertise, and integrate their software and hardware systems.
To identify the superbug, the firm used a rapid test that assigns microbial DNA fingerprints to reveal the clonal identity of a bacterial strain in patient samples.
By using menstrual effluent samples, the decidualization assay detects genetic biomarkers that may be linked to endometriosis.
The assay correlates shortened telomere lengths in patients of different ages to potential risks for inherited diseases, such as bone marrow failure syndrome and liver cancer.