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.
The US dollar was trading at NT$29.7 at 10am today on the Taipei Foreign Exchange, as the New Taiwan dollar gained NT$1.364 from the previous close last week. The NT dollar continued to rise today, after surging 3.07 percent on Friday. After opening at NT$30.91, the NT dollar gained more than NT$1 in just 15 minutes, briefly passing the NT$30 mark. Before the US Department of the Treasury's semi-annual currency report came out, expectations that the NT dollar would keep rising were already building. The NT dollar on Friday closed at NT$31.064, up by NT$0.953 — a 3.07 percent single-day gain. Today,
‘SHORT TERM’: The local currency would likely remain strong in the near term, driven by anticipated US trade pressure, capital inflows and expectations of a US Fed rate cut The US dollar is expected to fall below NT$30 in the near term, as traders anticipate increased pressure from Washington for Taiwan to allow the New Taiwan dollar to appreciate, Cathay United Bank (國泰世華銀行) chief economist Lin Chi-chao (林啟超) said. Following a sharp drop in the greenback against the NT dollar on Friday, Lin told the Central News Agency that the local currency is likely to remain strong in the short term, driven in part by market psychology surrounding anticipated US policy pressure. On Friday, the US dollar fell NT$0.953, or 3.07 percent, closing at NT$31.064 — its lowest level since Jan.
The New Taiwan dollar and Taiwanese stocks surged on signs that trade tensions between the world’s top two economies might start easing and as US tech earnings boosted the outlook of the nation’s semiconductor exports. The NT dollar strengthened as much as 3.8 percent versus the US dollar to 30.815, the biggest intraday gain since January 2011, closing at NT$31.064. The benchmark TAIEX jumped 2.73 percent to outperform the region’s equity gauges. Outlook for global trade improved after China said it is assessing possible trade talks with the US, providing a boost for the nation’s currency and shares. As the NT dollar
PRESSURE EXPECTED: The appreciation of the NT dollar reflected expectations that Washington would press Taiwan to boost its currency against the US dollar, dealers said Taiwan’s export-oriented semiconductor and auto part manufacturers are expecting their margins to be affected by large foreign exchange losses as the New Taiwan dollar continued to appreciate sharply against the US dollar yesterday. Among major semiconductor manufacturers, ASE Technology Holding Co (日月光), the world’s largest integrated circuit (IC) packaging and testing services provider, said that whenever the NT dollar rises NT$1 against the greenback, its gross margin is cut by about 1.5 percent. The NT dollar traded as strong as NT$29.59 per US dollar before trimming gains to close NT$0.919, or 2.96 percent, higher at NT$30.145 yesterday in Taipei trading
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