It’s a very rewarding trading day for investors in Precipio Inc (NASDAQ:PRPO) with shares up nearly 170%, making the stock Wall Street’s bull of the day. Why the excitement? The molecular diagnostics firm successfully incorporated the use of High Resolution Melt (HRM) technology into its ICE COLD-PCR™ (ICP) kits, substantially improving its liquid biopsy testing cost and time efficiency.
Customers using Precipio’s ICP for liquid biopsy may enjoy an additional reduction in their cost per specimen, potentially improving their margin by an estimated 25-50%, depending on the ratio of positive/negative cases).
This further strengthens Precipio’s ICP platform as what we believe to be the industry’s leading, most cost-effective technology for liquid biopsies.
The use of HRM as a screening tool enables laboratories to quickly and effectively rule out the patient samples that turn out negative for a genetic mutation in the region of interest. Obtaining that information through a simple and quick up-front step potentially eliminates the need to perform more complex and costly genetic mutation detection (e.g. next generation sequencing), significantly reducing the cost of testing and the wait time involved, from 7-10 days1, to a matter of hours.
Much like ICP, HRM can be applied to any of the downstream technologies ICP works on, such as RT-PCR, Sanger, and or NGS (expected 2nd half of 2018).
“The incorporation of HRM into our kits further sets ICP apart from all other competitors. While competitors focus on large, expensive panels, not easily reimbursed, our low-cost, efficient, reimbursable and targeted panels can now yield a same-day result (for negative cases),” said Ilan Danieli, Precipio’s CEO. “Our customer pipeline continues to grow as more laboratories realize the clinical and economic value that ICP brings them.”
What is High Resolution Melt (HRM)
HRM is a targeted screening tool used for the detection of genetic mutations in DNA. This technique has three main advantages over alternative mutation detection technologies:
- Cost effective – HRM analysis utilizes an inexpensive fluorescent dye to enable the detection of a genetic mutation.
- Speed – HRM testing requires approximately 2-4 hours to generate results, compared to 7 days for most laboratories using other gene sequencing technologies.
- Simplicity – HRM assays are simple, and don’t require laboratory technician expertise, enabling easy and quick adoption by facilities that do not have the staff expertise necessary for higher complexity gene sequencing.
HRM in Laboratory Work-Flow
The current process for identifying mutations in a blood sample involves two steps:
- Step 1: Enrichment. This step involves enriching the sample using ICP to amplify the tumor DNA relative to the normal DNA.
- Step 2: This step involves the actual genetic sequencing and analysis to identify the specific mutation.
Clinical industry data shows that often 50%2,3 or more of the specimens are negative, meaning there are no mutations present. However, to arrive at that result, both steps need to be completed, incurring both the time and cost of both those steps.
HRM enables laboratories to screen for those mutations in step 1 (enrichment), and provide a yes/no answer as to the presence of a mutation. Once step 1 is completed, the samples that have obtained a “negative” answer require no further testing, thus avoiding step 2. Only the specimens where the HRM test yielded a positive answer proceed to step 2 to determine the actual mutation.
The incorporation of HRM essentially enables laboratories to avoid running Step 2 for negative specimens (often representing 50% of cases). Each test run requires the utilization of expensive equipment; expensive reagents and controls required to run the test; and the time of laboratory technicians. By stopping the process at Step 1 for a portion of the cases, laboratories can report the same results quick, and reduce their costs by avoiding step 2. We believe this represents a 25-50% savings in cost of goods, as well as a reduction of approximately 40% of labor time per test, for customers who use our HRM-enabled ICP kits.
Clinical Advantage – Results in Hours, not Weeks
HRM may also substantially reduce results turn-around on at least 50% of the samples. Oncologists (and their patients) typically wait 7-14 days to receive molecular testing results critical to informed treatment decisions.
Laboratories can report back to clinicians within hours on cases that are negative for mutations. This potentially enables patients to be placed on the correct therapy within hours, rather than waiting weeks for results. In cancer, similar to other critical illnesses, time may be a critical factor in determining treatment; the sooner the patient is placed on the appropriate therapy, the higher the chances of success, potentially.
Impact on Precipio’s Business
The incorporation of HRM into our ICP kits further improves the economic and clinical value of ICP, our liquid biopsy platform, and we believe it places ICP at the forefront of the liquid biopsy alternatives available on the market.
We believe this unique capability will increase our platform’s competitive advantage and enable improved market share growth as hospitals and labs benefit from the improved ability to compete against much larger national laboratories and tertiary institutions.
HRM-enabled ICP kits currently available can impact patients with breast, gastric, lung, colon and pancreatic cancers, affecting more than 5 million patients in the US. Assuming a testing frequency of once a year (likely conservative in cases such as lung cancer, where testing is conducted 3-4 times per year), this equates to a potential domestic market of approximately $4-5B annually.