Kicking off the American Association of Clinical Chemistry’s (AACC) 71^st annual conference, Sunday August 4th’s plenary session featured the 2019 winner of AACC’s Wallace H. Coulter Lectureship Award, David R. Walt, PhD, of the Harvard Medical School & Wyss Institute for Bioinspired Engineering at Harvard University. In his talk, entitled  “Biomarker Discovery: From Technology Development to Clinical Applications,” Dr. Walt told two “stories of technology development” that illustrate how long it can take research technology to reach the diagnostics market, asking “how can we bring transformative technology to the clinic?” He went on to propose an alternative that would see the process reversed.

Dr. Walt’s technology development track record is well established. His work includes technology commercialized as DNA microarray and next generation sequencing (NGS) products by Illumina, a $3.3 billion company. In his talk, he described how his lab first began development of bead-based arrays in 1996, resulting in the 2002 commercial introduction of Illumina’s first microarray chip for research applications. But it was not until 2014 that microarrays began to make their way into the clinic. One of the first cases was the testing of embryos for a specific condition prior to IVF. Today, microarrays are regularly used for diagnostics testing, and are perhaps most well-known for direct-to-consumer tests such as the ancestry testing provided by 23andMe and Ancestry.com.

Advocating for a better model for making technologies more quickly available for clinical testing, Dr. Walt described a process that would start in the clinic with the identification of unmet needs.

Another technology journey described by Dr. Walt was SiMoA (single molecule arrays), an alternative to ELISA testing that vastly improves protein-detection sensitivity by digitally counting molecules. SiMoA assays and instruments are currently sold by Quanterix, which went public in 2017. Although Dr. Walt’s lab published its first paper on SiMoA in 2010, it was only last year that Quanterix introduced a benchtop instrument system for the research market. SiMoA has yet to penetrate the diagnostics market, but the company is currently investing in the use of its technology with neurofilament light protein biomarkers for diagnosing neurodegenerative conditions. Studies have also demonstrated SiMoA’s utility for earlier detection of conditions such as breast cancer.

Advocating for a better model for making technologies more quickly available for clinical testing, Dr. Walt described a process that would start in the clinic with the identification of unmet needs. Clinicians, scientists and engineers would then work together to create or adapt a technology to meet this need and demonstrate the technology’s clinical utility. At this point, investors would be solicited to fund technology commercializing. Development of clinical and research systems could happen in separate companies or simultaneously within the same company.

This process would contrast with today’s model, noted Dr. Walt, where technology development starts in labs and results in publications, leading to investments in companies that sell the technology to the research market. But, according to him, by the time such companies begin to address the diagnostics market, their revenue stream is already strongly tied to research markets. He said few companies participate in both the research and diagnostics markets. Dr. Walt used Illumina as an example, pointing out that it enables diagnostics applications of DNA microarrays and sequencers, but is not itself a diagnostics company. Rather, it is companies such as Genomic Health and Foundation Medicine that sell diagnostics assays based on sequencing.

Bringing new technologies to patients sooner is a pressing need, said Dr. Walt, and one that continues to frustrate inventors like himself.

For market data and information about clinical and diagnostics markets, please visit Kalorma Information.