NEW YORK – HTG Molecular Diagnostics plans to use its newly developed whole-transcriptome gene expression profiling platform, internally called WTTx, to develop oncology assays as well as tests for autoimmune disorders and infectious diseases.
The Tucson, Arizona-based firm expects to launch an early-access program by the end of the year, followed by a full commercial release of the platform in mid-2021.
On a conference call with investors following the release of earnings Tuesday afternoon, HTG CEO John Lubniewski discussed details about a completed white paper detailing WTTx's ability to measure a patient's entire transcriptome.
During the call Lubniewski said RNA-Seq is a "powerful technology," but pointed out in a follow-up email that that the method requires high-quality RNA and often a relatively high amount of the analyte.
In contrast, he believes that the WTTx product offers multiple advantages: the platform's chemistry and workflow eliminate RNA isolation and purification, as well as reverse transcription; it can use lower amounts of sample; it can work with degraded RNA; it has a turnaround time of two to three days; and it has "vastly simplified" bioinformatic requirements.
"The prototype whole-transcriptome panel demonstrated good directional alignment with RNA-Seq … [and] generated differential expressions that correlated with data generated by RNA-Seq [in the white paper,]" Lubniewski noted. "Additionally, [we found] excellent accuracy of different expressional analysis of spiked-in material."
HTG has been developing the clinical-grade, 22,000-gene WTTx platform since at least early 2019 at its San Carlos, California-based facility. However, Lubniewski said in the email that the firm ultimately closed the facility earlier this year following the completion of the program's research phase and white paper.
HTG will continue further development efforts after moving equipment and materials to its headquarters in Tucson. While the firm does not have any current plans to reopen the San Carlos lab, Lubniewski noted that his team is considering several options for the lab and "hopes to make a decision on its role within the next couple of quarters."
Lubniewski believes HTG can offer translational researchers and biopharma firms the ability to use the WTTx platform as "almost like an RNA operating system."
If a potential customer is interested in down-selecting to smaller panels from the WTTx platform, Lubniewski said that they can select specific probes from WTTx and incorporate them into smaller, more sequencer-efficient panels with "minimal revalidation."
HTG aims to launch an early-access program for the platform in December as part of its plans for continued technical development. The firm expects to publish an additional white paper that fully compares WTTx to RNA-Seq before the JP Morgan Healthcare Conference in January.
Following the second white paper, HTG will then identify initial commercial adopters in the first half of 2021, with an anticipated full commercial release in the summer.
HTG will also market the WTTx platform to three major groups: academic medical centers, pharmaceutical companies, and diagnostic firms developing their own gene expression tests.
Within academic medical centers, HTG will position the technology in translational research, where it believes the product will serve as an easier and more efficient technology than RNA-Seq for biomarker discovery. In addition, the firm hopes to act as an original equipment manufacturer (OEM) that academic CLIA-certified labs can use to build their custom signatures and develop laboratory-developed tests using the WTTx platform.
Lubniewski envisions that the WTTx platform will replace the firm's custom panels and act as a universal gene expression platform. If a potential pharma partner develops a signature and is eager to move forward with an investigational-use only collaboration, he expects the partner to down-select to a smaller panel between 100 and 1,000 genes.
"[WTTx] is not going to be that much more expensive to use than a 2,000- or 3,000-gene panel," Lubniewski explained. "If you have the ability to get all that data, an entire transcriptome, off one cut of tissue, I think that would be … a very attractive alternative to RNA-Seq, which uses a lot more sample."
Lubniewski said that HTG will offer pharmaceutical partners a "one-platform answer" in terms of RNA genomic expression to transition from biomarker discovery to developing a companion diagnostic assay.
HTG will also aim to work with companies who have begun developing their own gene expression assays. While the partners might use HTG's instrument and kits, some groups may also have an automated portion of existing workflows, which Lubniewski believes might instead lead to licensing or limited distribution agreements.
In addition to collaborations with academic and commercial groups, Lubniewski said that HTG is also developing its own clinical pan-breast cancer assay. The firm anticipates offering the test at some point in the future following the launch of the WTTx platform next year.
HTG expects to both sell instrumentation and kits to CLIA-certified labs as well as pursue 510(k) regulatory clearance with the US Food and Drug Administration for its own manufactured assays, including the envisioned pan-breast cancer assay.
To guide technical development of autoimmune and infectious disease-based diagnostic assays, HTG will run customer samples on WTTx and reach out to key opinion leaders to see how they would like to use the platform, with the potential to apply it in parallel with RNA-Seq.
Lubniewski noted his team may pursue potential conditions such as lupus and viral diseases like COVID-19. He believes the firm will be able to develop profiles and subtypes to potentially determine why patients respond in different ways when they have bacterial or viral infections.
"The panel is a powerful tool for translational researchers and biopharma [partners] to better understand the immune response in oncology, but also for immune disorders … and infectious diseases," Lubniewski said. "These are big markets, but we've been very encouraged that we can push [our] technology into markets beyond oncology."