NEW YORK – Invitae plans to add a variety of germline and somatic testing capabilities to its oncology testing pipeline and launch in vitro diagnostic kits to meet growing demand for local cancer testing capabilities in Europe, Asia, and the US.
During a call to discuss the firm's third quarter financials, Vishal Sikri, president of oncology at Invitae, provided more details about the company's forthcoming test launches and diagnostic development plans in oncology, which have been bolstered by the acquisition of ArcherDx last year.
By the end of the year, the company plans to launch expanded DNA-based research-use test kits that assess microsatellite instability and tumor mutation burden, he said. Tests for these biomarkers are in high demand since oncologists can use them to prescribe refractory cancer patients the immunotherapy pembrolizumab (Merck's Keytruda) in a tissue-agnostic fashion.
2022 promises to be a particularly busy year for Invitae's oncology segment, according to Sikri. The company will add polygenic risk scores, or PRS, to its germline genetic cancer risk test offerings and advance a single test that can gauge both germline cancer risk variants and somatic variants for guiding therapy decisions.
Longer term, Invitae has ambitions to offer its own early cancer detection test, Sikri said, though it will spend much of next year figuring out whether it will develop such a test internally or buy it.
While cancer patients are more likely to receive somatic tumor testing than germline testing, Invitae published a study last year showing that germline testing uncovered clinically actionable variants in 8 percent of patients that had not been picked up by earlier tumor sequencing.
As a result of this and other studies, genetic testing labs are considering new testing solutions. Invitae competitor Myriad Genetics, for example, said earlier this year it was working with Intermountain Healthcare to develop a combined offering that includes Myriad's myRisk Hereditary Cancer test and myChoice CDx, as well as Intermountain's TheraMap tumor profiling test. Once launched, oncologists will be able to receive results from all three tests in one report.
When Invitae bolsters its hereditary cancer test offerings with a PRS, it will again compete with Myriad, which for the past three years has been selling an 86-SNP polygenic risk score to inform the breast cancer risk of European and Ashkenazi Jewish women. This year, Myriad launched a new version of its 35-gene myRisk hereditary cancer test that provides a 140-SNP PRS score to all breast cancer patients regardless of ancestry.
In 2022, Invitae will also offer a series of lab-developed tests, including its Personalized Cancer Monitoring (PCM) test, which became available in June through an early-access program. Although the benefit of PCM has initially been demonstrated for monitoring progression of lung cancer, the company has plans to advance it as a pan-cancer monitoring test, Sikri said.
Invitae is also developing a tumor profiling LDT that assesses DNA, RNA, and protein biomarkers. That test will be similar to the distributed Stratafide test that Invitae garnered through the ArcherDx acquisition but it will have a different brand name.
Pent-up demand for local testing
Though Invitae has historically offered LDTs, it is now also able to launch IVD kits, aided by ArcherDx's expertise with the Stratafide test. According to Sikri, Invitae will start launching CE-IVD marked kits for profiling blood and tumor tissue in European and Asian markets next year, and work on advancing LDTs and kitted comprehensive tumor profiling tests in the US.
Specifically, the company plans to launch its first CE-IVD-marked kits — the FusionPlex Dx and the LiquidPlex ctDNA test — in select EU markets in the first quarter of 2022. "Both tests will enable any facility with sequencing technology and our solutions to accurately profile solid tumors and blood samples for therapy selection," Sikri said. "This is a major step toward satisfying the pent-up demand for local and regional genomic testing capabilities, particularly among EU countries and leading academic cancer centers."
In Japan, the company will also introduce kitted IVD solutions that will help "labs running the tests get higher reimbursement and therefore increase adoption," Sikri added.
These efforts are aimed at growing Invitae's presence in non-US cancer diagnostics markets. During Q3 of this year, testing outside the US comprised 21 percent of total billable test volume, according to Invitae CFO Roxi Wen. Moreover, the year-over-year quarterly increase in billable tests the firm saw was higher outside the US than in the US, she said.
In parallel with growing its ex-US business, the company plans to also work with US regulators to launch kitted, decentralized cancer testing solutions in its home market.
In August, Invitae had to write off a $262.5 million liability because it did not expect to obtain FDA approval of the Stratafide test by March 31, 2022, a regulatory milestone baked into the ArcherDx acquisition. During the call, Sikri said the company is "on track" with regulatory discussions on Stratafide, PCM, and other tests. "Based on the feedback from the FDA, we believe we have a good roadmap for FDA approval for our IVD products, including a path forward as an IVD for our PCM test," he said.
In the US, more cancer centers and regional health systems are looking to conduct tumor profiling in-house or locally in order to expedite turnaround time and lower costs. Illumina, for example, reported strong demand within its cancer IVD testing business in Q3. Specifically, its research-use comprehensive genomic profiling test, TruSight Oncology 500, recorded a record quarter with more than 340 customers installing the assay in their labs.
Roche, which markets Foundation Medicine's FoundationOne CDx test as an LDT, has also recognized the demand for distributed cancer genetic testing panels. The company recently launched the research-use Avenio Tumor Tissue Comprehensive Genomic Profiling Kit based on the genes and biomarkers included in the FoundationOne CDx and will sell the test to laboratories interested in installing in-house tumor profiling capabilities in Europe, North America, Asia, and South America.
Wen noted that Invitae expects its revenues next year to benefit from new IVD and LDT test launches for therapy selection and cancer monitoring, which have higher pricing than other tests in its women's health portfolio, for example.
Sales of Invitae's planned IVD kit launches may also be bolstered by the fact that more cancer centers and health systems are interested in installing in-house tumor profiling tests because the reimbursement environment for such assays has improved in recent years. A recent draft local coverage determination from Medicare contractor National Government Services, for example, has given cancer centers in New York, and in New England and certain Midwest states, reason to hope that they may start to get better payment for in-house next-generation sequencing cancer profiling.
Still, with Invitae now entering the highly crowded tumor profiling space, market analysts and investors are wondering how it will compete on price. Invitae CEO Sean George said during the call that Invitae's pricing strategy for cancer tumor profiling will be similar to its approach in the germline testing space.
In that market, Invitae introduced a tiered pricing system in 2015 that offered one rate for insurers with which its tests are in network or out of network, and capped the self-pay price for patients to a few hundred dollars. This pricing strategy allowed the company to broaden test access to patients who didn't meet insurers' coverage criteria, take market share from competitors like Myriad, and grow its presence in germline genetic testing.
"It's worth noting that where a price exists, Invitae has always taken that price," George told analysts on the call. "Where we have used price to grow volume or grow markets is where there are no reimbursed criteria for a given service that we think is really valuable for extending the life of our customers … who otherwise the system in our industry wasn't going to serve."
Invitae's pricing approach will be similar in the tumor profiling space, George said, noting that these tests enjoy high payor pricing in the US. "Really high pricing offered by [the Centers for Medicare & Medicaid Services] and anybody else we will take," he said "And then, for the remaining 28 million cancer patient around the globe, who don't have reimbursement coverage, that's where our cost advantage and our distribution can really come into play, whether serving at the individual or the government level."
Early cancer detection: build or buy?
Over the long term, Invitae has its sights on launching an early-detection cancer screening test, which like cancer tumor profiling is a crowded and rapidly growing market. At the moment, it is not yet clear if the firm will develop an early cancer detection test in house or acquire it. "We're currently doing our own work on what our technologies would look like in the trials and validations and, of course, looking at the buy scenario as well," George said.
Illumina subsidiary Grail and others have conducted very large studies, involving thousands of patients, to demonstrate the ability of their liquid biopsy tests to detect early cancer signals. But Sikri said it's not necessarily the company's goal to invest in a 10,000-patient study, as other companies in the space have done.
"Most of the action for next year is going to be in risk assessment, therapy selection, [cancer] monitoring, and really taking our product portfolio from start to finish for our oncology patients," George added.