NEW YORK – Following the termination of its agreement with Exact Sciences subsidiary Genomic Health, Biocartis plans to further invest in current collaborations and future projects with firms to develop in vitro diagnostic (IVD) tests for multiple cancer types and infectious diseases.
While the COVID-19 pandemic derailed Biocartis' partnership with Genomic Health, the Belgian molecular diagnostics firm separately announced earlier this week that it is partnering with GeneproDx and Endpoint Health to develop IVD assays on the Idylla platform.
Biocartis originally partnered with Genomic Health in 2017 to develop an IVD version of the firm's Oncotype DX Breast Recurrence Score test on the Idylla instrument, with plans to launch the test in 2019. The partners signed an additional agreement in 2018 to develop an IVD version of Genomic Health's Oncotype DX Genomic Prostate Score Test.
While the collaborators did not need to modify the Idylla platform to accommodate Genomic Health's assays, Biocartis CEO Herman Verrelst said that they had to adapt the chemistry to specific biomarkers for breast and prostate cancer.
"Obviously, you'd fine-tune that not only in the primer probes, but the buffer mix [as well]," Verrelst said. "The flexibility we have in our platform … [such as] the ability to formulate sample extraction and PCR protocols … allows us to accommodate a wide variety of chemistries."
In July 2019, Exact Sciences acquired Genomic Health for $2.8 billion, which delayed the planned timeline for the launch of the breast cancer assay. However, Verrelst highlighted that the partners had still planned to launch the assay in 2020.
He noted that the firms had finished assay development in late 2019 and were about to launch European clinical validation studies. However, their plans were hampered by the start of the COVID-19 pandemic in Europe, as they could not access hospitals due to an influx of COVID-19 patients and lockdown restrictions.
Biocartis initially noted during its H1 earnings call in September that it had suspended the partnership with Exact Sciences due to the COVID-19 pandemic. Verrelst said that the firms then accelerated discussions to terminate the project, as both parties "agreed it would be challenging to continue the program."
"Over that period, we had been talking with Genomic Health and Exact Sciences about the uncertainty of when we could initiate these trials," Verrelst said. "Exact Sciences had [also] turned its attention elsewhere, such as acquisitions."
As part of the termination, Exact will pay Biocartis a settlement of $12 million. Verrelst said that Exact will also transfer infrastructure — mainly Idylla instruments — that was built as part of the research and development stage to the company. In addition, the firms will cease licenses and exclusivity agreements as part of the settlement, which Verrelst said will give both parties the freedom to begin future collaborations in the breast and prostate cancer spaces.
While acknowledging that the breast cancer assay would "have been a nice addition to our menu," Verrelst stressed that the test was only one of many assays in Biocartis' broader test menu. He pointed out that the breast cancer assay was only targeted — at least initially — for the European market and thus does not impact the firm's US or rest-of-the-world strategy.
"[Oncotype DX Breast Recurrence Score] would have been a powerful test and have clear clinical benefit for breast cancer patients, but it was not going to be a cornerstone of our go-to-market strategy," Verrelst said.
Declining to comment on the firm's internal revenue projections if the collaboration with Genomic Health had led to a commercialized assay, Verrelst instead noted that the firm received a "fair compensation from the lost agreement."
Exact said that it is working on alternative ways to offer its Oncotype DX Breast Recurrence Score locally in Europe, starting with Germany by the end of 2021, but declined to provide specifics.
While the COVID-19 pandemic led to the collapse of Biocartis' plans to develop the Oncotype DX IVD assay on its Idylla platform, the firm is shifting its priorities and pursuing assays in additional cancers and other disease-based applications, including in the recently announced collaboration with Santiago, Chile-based GeneproDx.
Verrelst said that the partnership with GeneproDx will involve both an R&D and a commercial phase to build an IVD version of GeneproDx's ThyroidPrint multiplex quantitative PCR genetic classifier. Biocartis will provide the Idylla platform and clinical resources to allow the team to port the test to the Idylla instrument, followed by clinical testing to demonstrate the test's performance and equivalence to the original CLIA-based version.
Spun out of the Catholic University of Chile in 2014 by Hernán González, GeneproDx currently offers a laboratory-developed version of the ThyroidPrint assay — which uses a patient's fine needle aspirate sample — out of its CLIA-certified, CAP-accredited lab in Santiago. González had noted earlier this year that the firm had raised funding to develop an IVD version of the assay for Europe and other markets.
The ThyroidPrint assay is intended to more accurately and quickly identify if a patient with indeterminate thyroid nodules is at risk of developing thyroid cancer. After processing qPCR data using a proprietary algorithm, the platform provides a score that predicts whether a sample is benign or malignant.
Unlike under the agreement with Genomic Health, Verrelst said, Biocartis will have an active commercial role in the collaboration with GeneproDx due to its broad and established distribution network in the US and European markets.
"While the exact timing is not yet clear, as we need to start the actual technical development stage, we aim to launch the test region by region," Verrelst said. "We have experience in Europe with CE-marking, but we will still need to identify the path for the US, whether that be a CLIA-certified [test] or [the US] Food and Drug Administration route."
Biocartis is also collaborating with Palo Alto, California-based startup Endpoint Health to license, develop, and commercialize the Endpoint CDx assay on the Idylla instrument to guide treatment decisions for critically-ill patients with infectious disease in emergency rooms or intensive care units.
For example, Verrelst said that the envisioned IVD test could be used for patients in the advanced stages of sepsis or acute respiratory distress Syndrome (ARDS). The firms aim to create a targeted host response signature to properly characterize patients and decide which therapy to prescribe, such as immunotherapy or coagulation therapy.
While Verrelst declined to disclose how many genes the firms will include as part of the assay's gene signature, he highlighted that the Idylla instrument can examine "up to tens of genes, so we can go up to reasonably high multiplexing capabilities."
By focusing on a sample-to-result approach "without intervention," Verrelst envisions that users will be able to place a patient's blood sample in a cartridge on the Idylla instrument and produce results "roughly within an hour."
Under the agreement, the firms plan to begin a "broad interventional trial" for the Idylla Endpoint CDx assay later this year.
"With Endpoint, we are looking at RNA expression markers in the host to help inform which therapies are best suited to the patient," Verrelst said. "There's broad potential ... of looking at multiple genes that play a role in the hosts' response to infection and — based on the different expression levels — that can help inform which therapies work best."
However, Verrelst said that Biocartis does not currently have a clear commercial timeline for launching the ThyroidPrint and Idylla Endpoint CDx assays on its instrument.
Verrelst highlighted that Biocartis is pursuing discussions with additional undisclosed firms to develop IVD versions of their assays, as well as collaborations with different pharmaceutical partners including Amgen and Bristol-Myers Squibb. The firm is also working with UK-based LifeArc to develop infectious disease and immune-related disease assays.
"We can reinvest the [termination settlement] money, in some of these other programs or other partnerships, [but] the decision will be based on the merit of the project and collaboration," Verrelst said. "Breast cancer remains interesting, and we will consider our options in that market."
Biocartis also later this year plans to introduce a new, rapid test called SeptiCyte Rapid in Europe with Immunexpress. Verrelst said that the assay is a host-response test that distinguishes sepsis from non-infectious systemic inflammation in patients suspected of sepsis and provides results in about an hour.
Verrelst also noted that Biocartis submitted its PCR-based SARS-CoV-2 test to the US Food and Drug Administration for Emergency Use Authorization in August. The firm anticipates to commercially launch the test in 2021. In parallel, Biocartis is also developing an extended version of the SARS-CoV-2 assay that will test for the flu and RSV.
"We recognize that Exact and Genomic Health are household names, but we are not dependent on this collaboration for the future of the company's health," Verrelst said. "We will focus our current efforts in lung cancer and both internal and collaborative efforts moving forward."