NEW YORK – Belgian molecular diagnostics firm Biocartis said on Tuesday it has signed a license, development, and commercialization agreement with startup GeneproDx to develop GeneproDx's ThyroidPrint on Biocartis' Idylla platform, as well as a separate agreement with Endpoint Health to develop and commercialize a novel companion diagnostic (CDx) test on the Idylla instrument.
Under the terms of the agreement with Santiago, Chile-based GeneproDx, the startup will take the lead in developing the Idylla ThyroidPrint test, while Biocartis will be responsible for the global distribution of the assay.
GeneproDx's ThyroidPrint assay is a qRT-PCR-based, mRNA classifier that helps clinicians decide whether a thyroid nodule with an indeterminate cytology result is benign or malignant.
"As clinicians, an important challenge today is to determine whether a thyroid nodule is malignant and a patient really needs to undergo surgical resection of the thyroid gland," Hernán González, founder of GeneproDx, said in a statement. "In our first real world clinical utility experience, ThyroidPrint revealed a meaningful impact on the physician decision by reducing diagnostic surgery by more than 70 percent in patients with indeterminate cytology."
"By developing an Idylla version of ThyroidPrint, GeneproDx and Biocartis may enable broad availability of this test to laboratories and hospitals around the world, to help address this high clinical unmet need in thyroid patients," Herman Verrelst, CEO of Biocartis, added. "For Biocartis, this also means further expansion of the oncology menu into thyroid cancer."
As part of Biocartis' agreement with Palo Alto, California-based Endpoint, that company will lead development and registration of the Idylla Endpoint CDx test in interventional trials across a range of interventions, including targeted immunotherapy and coagulation therapy indications. The firms plan to collaborate on the commercialization of the Idylla Endpoint CDx test.
The test is being developed for critical illnesses such as sepsis and acute respiratory distress Syndrome.
"Endpoint Health's mission is to bring lifesaving targeted therapies to the right patient at the right time," Jason Springs, CEO and cofounder of Endpoint Health said in a statement. "Our partnership with Biocartis is a key component to identifying and delivering personalized medicine to each critically ill patient."
Biocartis and Endpoint plan to begin development of the Idylla Endpoint test later this year.
"We are very excited to work with Endpoint Health to deploy a rapid companion diagnostic test that is aimed at enabling targeted therapies and personalized care approaches in the area of critical illness," Verrelst added. "In addition to our current infectious disease tests … the Idylla Endpoint CDx test is expected to guide the safe and effective use of novel therapies as well as improve routine care choices in critically ill patients who often only have a matter of hours to treat their condition."
Financial details of the two deals were not disclosed.