KaloramaTests that can harness the speed and efficiency of DNA testing but take up a small space in a clinical lab or be used near the patient are a reality, according to Kalorama Information. There are several marketed products and many in development, the firm says.

Kalorama Information expects significant growth by 2020 in an area now termed the molecular point-of-care (POC) diagnostics market, which reached $74 million in 2015. Among the various technologies and products of the global in vitro diagnostics (IVD) market, molecular diagnostics performed at the point of care or near the patient are regarded as a leading expansion market.

Molecular POC diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics and community health posts in the developing world. The healthcare market researcher’s report, The Market and Potential for Molecular Point of Care Diagnostics, examines the major segments of molecular POC diagnostics, exploring in-depth both current sales and market opportunity.

“Molecular POC products will be able to address a segment of hospital POC testing, largely related to infectious diseases,” said Bruce Carlson, Publisher of Kalorama Information. “Rapid POC testing of hospital patients for pathogens can optimize decisions regarding patient isolation or quarantine and required urgency for intervention.”

Molecular point-of-care (POC) diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care. Clinical molecular diagnostics have steadily progressed from research-emergent, highly complex tests performed in few labs to analyser-integrated and automated steps from sample preparation through results analysis.

The market introduction of POC diagnostics or tests often follows a period of technological maturation or refinement of an existing laboratory diagnostic modality or platform. One of the major enabling technologies for POC testing with molecular diagnostics is real-time polymerase chain reaction (qPCR) testing that eliminated the need for post-amplification electrophoresis and integrated detection within the same instrument that performed amplification.

Advances and innovations in microfluidics, isothermal and other alternative amplification chemistries, test automation, primers and probes, and next-generation sequencing (NGS) methods have been fundamental to the development of decentralized molecular diagnostics. In many cases, these technologies work together to facilitate clinical molecular testing in an automated manner within a smaller device.

While molecular POC diagnostics currently represent a minimal market within IVD with limited product availability, the demand for decentralized molecular testing beyond reference and hospital labs is expected to grow dramatically during the next 5 years with molecular POC diagnostic product introductions. Tests assaying nucleic acid analytes offer unparalleled analytical specificity, sensitivity and multiplex capabilities in clinical POC settings.

The Market and Potential for Molecular Point of Care Diagnostics examines the major segments of molecular POC diagnostics, exploring in-depth the following: molecular POC market for respiratory tract infections (2015-2020), molecular POC market for women’s health and sexual health (2015-2020), molecular POC market for high-burden diseases (2015-2020), molecular POC market for GI pathogens, HAIs and bloodstream infections (2015-2020), and molecular POC market for non-infectious diseases (2015-2020).

The report has gathered as well data on the following: investments in decentralized molecular diagnostics companies (2014-2015) and molecular POC test markets for respiratory tract infections, women’s health and sexual health, high-burden diseases, GI pathogens, HAIs, bloodstream infections, pharmacogenetics, other genetics, and cancer testing (2015-2020).

Profiled companies include those with clinical molecular diagnostic systems applicable to POC testing markets, molecular diagnostic systems applicable to hospital lab molecular testing; development-stage molecular diagnostic systems for decentralized testing, molecular diagnostic products for use primarily in emerging markets of the developing world and for field testing, companies with original equipment manufacturer (OEM) platforms and component technologies that could be featured in the molecular POC diagnostics market, and other companies that have been involved in molecular POC diagnostics through investment, collaborative research or technology development that could allow them to enter the market.

For more information on Kalorama’s report, The Market and Potential for Molecular Point of Care Diagnostics, click here.