TPEX Emerging Stock Board-listed Applied BioCode Inc (瑞磁生物科技) yesterday announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the company to market a new diagnostic device.
The company’s ex vivo diagnostic device, the BioCode MDx3000, is capable of diagnosing 17 types of gastrointestinal pathogens, bacteria, viruses and parasites using a bioassay solution.
The BioCode MDx3000 would be the first automated and high-throughput diagnostic device on the US market capable of processing 94 samples in 3.5 hours, or up to 3,384 during an eight-hour shift, with reduced hands-on time and a lower risk of sample contamination, the company said.
The device uses the company’s barcoded magnetic bead technology, which use a semiconductor process to improve cost effectiveness and readings with pathological complete responses, it said.
To leverage the device’s high throughput, the company said it is seeking customers among US hospitals with more than 400 beds, as well as among larger laboratories.
The company said it received the FDA’s premarket approval after conducting 1,558 tests at Taiwan’s Centers for Disease Control and four US hospitals.
In January, the company signed an exclusive global agreement with US-based IDEXX Laboratories Inc, a leading pet and veterinary medical services provider, to tap into the animal health diagnostics market.
In April, the device also received certification for CE marking, which is required for products sold in the European Economic Area.
The company reported a net loss of NT$118.9 million (US$3.9 million) in the first six month of the year, up from NT$165.52 million in the same period last year, with net loss per share decreasing from NT$3.06 last year to NT$2.42.
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