Changing the Future of Multiplexing

ChromaCode, based in Carlsbad, CA, combines innovative data science and biochemistry to build more affordable research and diagnostic molecular testing solutions. Their HDPCR™ multiplexing technology enables global deployment of robust products using existing equipment and standard workflows to increase qPCR multiplexing by 4 times and dPCR multiplexing by 10 times to fulfill unmet clinical and research needs in infectious disease, noninvasive prenatal testing (NIPT) and oncology.

In this interview, co-founder Greg Gosch shares insights into the science of multiplexing, discusses how ChromaCode is redefining molecular diagnostics and explores how HDPCR is shaping the future of what’s possible in COVID-19, related respiratory and other disease testing.

Q: What does the current molecular diagnostics landscape look like?

A: Never before has there been so much information and discussion circulating about molecular diagnostics and its critical role in disease diagnosis. Until recently, “PCR” was typically a term used by lab scientists. But, over the past 20 months, COVID-19 made the terminology more mainstream, bringing it into households around the world. Molecular diagnostics includes testing methods that analyze the sequences of DNA or RNA to look for indicators of potential emergence of a specific disease. It has revolutionized the capabilities of clinical laboratories. The introduction of automated instrument systems that utilize polymerase chain reaction (PCR), a fast and inexpensive technique used to amplify DNA, has made this testing practice widely accessible, allowing labs of all sizes to play a significant role in patient treatment by providing insight to a variety of diseases.

For COVID-19, diagnostic testing works by looking for the virus's genetic material in a small sample, generally acquired by swabbing a person’s nose. As the pandemic escalated, ChromaCode quickly pivoted, to design a SARS-CoV-2 molecular test with input from a team at UCSD to meet the significantly increased demand for worldwide COVID-testing. Crucial to the deployment of this multiplexing technology was the development of the ChromaCode Cloud™. The proprietary software advanced standard PCR testing by enabling broader multiplexing, improving access to data interpretation, and simplifying use.

Q: What is high definition multiplexing, and how is ChromaCode’s technology different?

A: ChromaCode has simplified the historically complex ability to test for multiple disease targets simultaneously, or multiplexing, with its trademarked high-definition PCR (HDPCR). This technology incorporates unique biochemistry strategies with ChromaCode Cloud software and uses traditional qPCR or dPCR instruments. Without changing the workflow or instrument hardware or software, HDPCR provides a 4x–10x expansion of the analytical capability of PCR instruments. It uses digital signal processing, enhanced PCR chemistry and cloud-based analytics to significantly increase testing capabilities while decreasing costs. ChromaCode is currently utilizing this technology to accurately identify SARS-CoV-2, other respiratory viruses, tick-borne diseases and multi-drug resistant bacterial infections. In the future, applications will expand to include NIPT, non-small cell lung cancer and other genomic tests.

Specific to the COVID-19 testing innovation, ChromaCode’s HDPCR solution was recently recognized as a winner in the XPRIZE Rapid COVID Testing competition, which provided funding to increase access to COVID-19 testing capabilities globally.

Q: How is ChromaCode redefining molecular diagnostics?

A: According to a 2021 Emergen Research report, the global molecular diagnostics market is expected to reach $16.49 billion in 2027 at a CAGR of 8.7%. This expected growth has been driven by the demand to address ongoing testing needs for the continuing worldwide presence of COVID-19 as well as many other infectious and genetic diseases. Specifically, the PCR testing segment accounted for a revenue share of 38.4% in the 2019 global market and is steadily growing. But traditional qPCR and dPCR tests and even standard multiplexing have their limitations. Labs are seeking technological innovations that raise the bar.

ChromaCode’s proprietary HDPCR technology is transforming molecular diagnostics by unlocking the potential of the existing qPCR and dPCR instruments by expanding the number of detectable disease targets in a single reaction at very low cost, thus removing the limitations for traditional PCR tests. Our integration of innovative data science and biochemistry on these existing hardware platforms will ultimately lead to better testing access for patients enabling them to receive the most appropriate, potential life-saving treatments more swiftly.

Q: How does HDPCR broaden access to patients?

A: In every industry, technology has a transformational power that has evolved, shaped and dictated what’s possible. In today’s healthcare world, patients are better informed and are looking for more than just a quick prescription. We enable physicians to make more informed decisions. Better information leads to better treatment and improved outcomes. ChromaCode’s technology plays a key role in strengthening that desired physician/patient interconnectivity by making comprehensive diagnostic tests more accessible and affordable.