Biocartis and GeneproDx To Collaborate on
Fully Automated ThyroidPrint® test on Idylla™
Mechelen, Belgium, 3 November 2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative
molecular diagnostics company (Euronext Brussels: BCART), today announces it has signed a license,
development and commercialization agreement with GeneproDx, a molecular diagnostics company based in
Santiago, Chile, for the development of GeneproDx’s novel genomic test ThyroidPrint® on Biocartis’ rapid
and easy to use molecular diagnostics platform Idylla™.
Under the terms of the agreement, GeneproDx will take the lead in the development of the Idylla™
ThyroidPrint® test, whereas Biocartis will be responsible for the distribution of the ThyroidPrint® on Idylla™
through its growing commercial infrastructure of Idylla™ instruments across the globe.
Thyroid nodules are very common and are often detected during routine medical exam or by patient self-
assessment. Only some 10% of fine needle aspirate (FNA) biopsy procedures1
reveal the presence of
malignant cells, while approximately 70% confirm a benign (non-cancerous) diagnosis. The remaining 20%
are reported as indeterminate, meaning that no certain diagnosis can be provided to physician and patients2
.
Annually, over 1.2 million thyroid cytology evaluations are reported as indeterminate3
. In patients with such
result, diagnostic surgery of the thyroid gland is frequently recommended4
. The risk of malignancy in these
indeterminate cases is estimated to be between 15-35%, meaning that surgical intervention is unnecessary
in up to 65-85% of these cases4
.
ThyroidPrint® is a qRT-PCR5 based mRNA-expression classifier6
test that helps to determine whether a thyroid
nodule with an indeterminate cytology result is benign or malignant7
. A benign test result8 allows physicians
to recommend watchful waiting as an alternative to diagnostic surgery. This prevents exposing patients to
surgical risks and permanent thyroid hormone supplementation. Moreover, it significantly reduces health
costs associated with unnecessary surgery3
.
GeneproDx’s ThyroidPrint® was initially clinically validated in a multicenter trial in Chile, after which it was
launched in Latin America3
in September 2018. Furthermore, the test was clinically validated in a second
independent multicenter, prospective trial in the US in December 2019, demonstrating that ThyroidPrint®
performs in the same manner in populations with different ethnicities and genetic backgrounds 9
. Currently,
a new international validation study is ongoing, including an estimated 200 individuals with indeterminate
cytology results10, in leading academic sites in Europe, the US and Latin-America.
Herman Verrelst, Chief Executive Officer of Biocartis, commented: “We are very pleased to enter
into a new collaboration where a high value gene signature test is ported on Idylla™. 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. For
Biocartis, this also means further expansion of the oncology menu into thyroid cancer.”
Hernán González MD, PhD, Professor of Surgery at the Pontifical Catholic University of Chile and
Founder of GeneproDx, reacted: “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. 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% in patients with indeterminate cytology
11
. We are
excited to use the rapid and easy-to-use Idylla™ technology to develop a ThyroidPrint
® test that physicians
can request to be performed in their local laboratories. As such, patients across the world can have the first
of its kind, fast and easy-access diagnostic solution for indeterminate thyroid cytology results.”
Development of the ThyroidPrint® on Idylla™ will be initiated in Q4 2020.