General Biologicals Corp (GBC, 普生) on Friday said that its hepatitis D diagnostic testing products are to be the first to gain approval from Taiwanese regulators.
The company, which focuses on in vitro diagnostic systems, said it expects to see wider utilization of its products among medical institutions in the local market by early next year, which would underpin potential profit growth.
“We are expecting significant growth from the hepatitis D testing market in the absence of any local competitors,” General Biologicals president David Hsia (夏大維) told a news conference in Taipei.
Hepatitis D, also known as “delta hepatitis,” is an infection that causes the liver to become inflamed.
The disease is evolved from the more prevalent hepatitis B virus and has been included in the National Health Insurance program, Hsia said.
While treatment options are underdeveloped for hepatitis D, medical institutions and health regulators have been pushing for more testing and diagnostic work to find out more about the disease.
The emphasis on testing is part of ongoing trends in precision and preventative medicine, Hsia said.
He said that the company’s solutions would allow physicians to prescribe a tailored treatment regimen for each patient according to the outcome of screening tests on metrics such as virus concentration.
To combat inherited liver disease passed from parent to child, pregnant woman might be prescribed tests by prenatal care providers, he added.
The company’s cumulative sales in the first 10 months of this year rose 16.53 percent annually to NT$157.42 million (US$4.95 million), company data showed.
In August, the company’s testing products for hepatitis C gained approval from regulators to become the only locally developed solution that competes with products made by Abbott Laboratories and Roche Holding AG, General Biologicals said.
This month, the company presented its findings on a testing solution for HER2-positive breast cancer at an Association for Molecular Pathology annual meeting at Charlotte Convention Center in Charlotte, North Carolina.
The HER2 test overcomes limitations of conventional testing methods, such as the low accuracy of immunohistochemistry methods, as well as the high costs and lengthy turnaround time of fluorescence in situ hybridization (FISH) testing, the company said.
Preliminary trials show that the HER2 test has demonstrated a 90 percent consistency rate when compared with FISH testing, the company said, adding that the new solution would greatly boost its presence on the in vitro diagnostic market.
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