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BioHelix Gets FDA Nod for First Point-of-Care MDx Test


By Ben Butkus

BioHelix said this week that it has been granted 510(k) clearance from the US Food and Drug Administration for its IsoAmp HSV Assay for detecting herpes simplex virus in genital and oral lesion specimens from symptomatic patients.

The IsoAmp HSV Assay is BioHelix's first FDA-cleared molecular diagnostic test, and is based on the company's first-generation disposable handheld device using the company's helicase-dependent amplification technology and lateral flow strip detection scheme.

BioHelix is also developing molecular tests on the IsoAmp platform for other infectious disease, including chlamydia, gonorrhea, and tuberculosis. In the meantime, it continues to collaborate with researchers at Boston University to develop a next-generation version of its platform; and with Quidel to develop additional molecular diagnostic tests for use on the current platform, President and CEO Huimin Kong said this week.

BioHelix's IsoAmp HSV Assay can provide results within 1.5 hours, the company said. It is not cleared for use with cerebrospinal fluid, does not differentiate between HSV-1 and HSV-2, and is not intended for prenatal screening, the company said.

The IsoAmp platform is a single-use, handheld detection device that uses the company's HAD and lateral flow strip detection technology. The current platform requires a technician to perform a one-step dilution sample-preparation method, which is followed by isothermal nucleic acid amplification and visual detection of the amplification products.

Beverley, Mass.-based BioHelix is also working with researchers at Boston University to develop a next generation of IsoAmp that would fully automate the sample prep aspect of the test, resulting in a true "sample-in, answer-out" platform. This project is being supported in part by a two-year grant from the National Institute of Allergy and Infectious Diseases awarded to the company earlier this month (PCR Insider, 10/13/11).

"The only difference between the current platform and the future platform is that the current platform still requires a technician to measure out sample and reagents," Kong told PCR Insider this week.

However, that platform is "still a long way" from the market, Kong said. In the meantime, the company continues to develop molecular diagnostic tests for the current version of IsoAmp.

"Now that the HSV test is cleared, we intend to market and sell it ourselves," he said. "Others in development include tests for [Chlamydia trachomatis and Neisseria gonorrhoeae] and tuberculosis."

BioHelix also has an ongoing partnership with Quidel to develop isothermal amplification-based molecular tests for five infectious disease targets for use on the IsoAmp platform, or potentially Quidel's own point-of-care device, still under development (PCR Insider, 4/14/2011).

BioHelix has also licensed the HAD technology to other companies for molecular diagnostic applications. For instance, industry newcomer Great Basin said in February that it was incorporating the isothermal amplification technology in its cartridge-based, sample-to-answer molecular testing platform (PCR Insider, 2/17/11).

Qiagen had licensed the HAD technology in 2008 with plans to combine it with its hybrid capture 2 technology for various molecular diagnostic tests, including for chlamydia and gonorrhea. However, in May Qiagen said that it was scuttling the isothermal amplification method in favor of PCR-based tests for assays to be run on its next-generation QIAensemble Revolution molecular testing platform (PCR Insider, 5/12/11).

Have topics you'd like to see covered in PCR Insider? Contact the editor at bbutkus [at] genomeweb [.] com.