• Incidence Testing
• Rapid Test Platform
• Oral Fluid Sampling System
• Molecular Diagnostics

MOLECULAR DIAGNOSTICS

Calypte is dedicated to leveraging the latest technologies to making diagnostic testing more available and reliable everywhere. Molecular Diagnostics have, in recent years, emerged as the next big step forward and Calypte is working to develop a nucleic acid-based diagnostic testing platform. Nucleic acid-based tests will be able to detect many diseases and conditions that cannot currently be diagnosed using serological methods. And even for diseases that can be detected using serological methods, nucleic acid-based tests will shorten the time between exposure and when an infection can be detected. For example, HIV can often be detected two or more weeks earlier using nucleic acid amplification methods than with serological tests.

Cloning for protein expression (genetic engineering) usually involves taking some of the DNA from an organism, such as a virus, and putting the DNA in an organism that is safely, easily and inexpensively grown, such as yeast. The yeast then makes the viral protein of interest. Calypte has acquired this technology to custom design antigens (such as viral proteins) needed for our diagnostic tests.

Detection of specific nucleic acids (DNA/RNA) can be used to diagnose infection with viruses. For example, if influenza RNA is present in the back of a patient’s throat, a physician can know for certain that the patent is infected with influenza. Additional commercial uses of nucleic acid detection/identification include paternity testing and forensics. Many of these applications will work with “alternative fluid specimens” such as oral fluid or urine.

Polymerase Chain Reaction (PCR) was the first and remains the best known of the nucleic acid amplification methods. Alternatives to PCR were initially sought because of the patent situation, and other early commercial techniques included the ligase chain reaction and transcription-mediated amplification (TMA/NASBA). More recently, schemes have been developed that can operate at a single, high temperature such as Strand Displacement Amplification (SDA), Helicase Mediated Amplification (HMA), and Loop-mediated AMPlifcation (LAMP). Under optimal circumstances, all of these methods can detect a single molecule of DNA/RNA, although in practice detecting 10 or 100 molecules is much easier.

Currently in the U.S., medical nucleic acid detection tests are run primarily by reference labs. Commercialization of these tests has historically been limited to major producers of expensive, dedicated equipment and to cumbersome, labor-intensive methods. Calypte believes that improvements in instrumentation and in nucleic acid amplification methods now allow for the development of nucleic acid based diagnostic testing products suitable for hospital laboratories as well as point-of-care settings. Calypte is dedicated to remaining on the forefront of new diagnostic technology applications and on advancing standards of care through new technologies.