Press news Biocartis Group NV: BIOCARTIS ANNOUNCES H1 2020 RESULTS
PRESS RELEASE: REGULATED INFORMATION
3 September 2020, 07:00 CEST
BIOCARTIS ANNOUNCES H1 2020 RESULTS
Mechelen, Belgium, 3 September
2020 – Biocartis Group NV (the ‘Company’ or ‘Biocartis’),
an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces its business highlights and financial
results for the first half of 2020, prepared in accordance with IAS
34 ‘Interim Financial Reporting’ as adopted by the European Union.
Furthermore, the Company reinstates its outlook for the full year
2020.
Commenting on the H1 2020 results,
Herman Verrelst, Chief Executive Officer of Biocartis,
reacted: “The global pandemic definitely left its marks,
but we nevertheless delivered a 12% growth of overall commercial
cartridge volumes in H1 2020. Supported by a loyal customer base
and a swift recovery towards the end of Q2 2020, the net impact
from COVID-19 was limited in Europe: growth of European cartridge
volumes remained robust and is now back in line with our
pre-pandemic expectations. After a strong Q1 2020, the recovery was
less pronounced in the US. Here, we saw new instrument placements
stalling as lockdown measures prevented all new customer
prospection during the entire Q2 2020. As such, we expect a
prolonged effect of the pandemic into H2 2020 in the US. RoW1
volumes were most impacted in H1 2020 and timing of recovery is
still uncertain. However, the need for high quality, rapid and easy
diagnostic testing for every patient is more obvious than ever. In
oncology, we managed to stabilize our business and return to growth
in Europe and the US mainly thanks to Idylla™’s fully automated
testing which has shown to be very useful in times where all lab
resources are focused on priority pandemic testing. Next to that,
we now see complimentary opportunity in infectious diseases and we
have developed an Idylla™ SARS-CoV-2 Test for which we expect
strong demand in H2 2020, particularly in the US. Comforted by the
resilience of our oncology business, most notably in Europe, and
the expected demand for the Idylla™ SARS-CoV-2 Test, we look ahead
with confidence and reinstate our full guidance for 2020.”
KEY MESSAGES
- Commercial cartridge volume:
- Nearly 80k cartridges sold in H1 2020, a year-over-year
increase of 12%, despite the COVID-19 pandemic;
- After a strong 68% year-over-year growth in Q1 2020, Q2 2020
volumes came in 20% lower than last year;
- Europe: Strong continued growth in Q1 2020 and recovery by the
end of Q2 2020, offsetting the impact of the pandemic in early Q2
2020;
- US: Strong volume growth in Q1 2020, but recovery in Q2 2020
less pronounced, as COVID-19 cases remain high in many States.
Prolonged impact of the pandemic expected into H2 2020;
- RoW: After a strong Q1 2020, RoW volumes were most impacted
with limited visibility on recovery.
- Installed base:
- 101 new Idylla™ instruments placed versus 156 in H1 2019;
- Total installed base of 1,411 end H1 2020;
- 50% of the new placements in Europe. Pace of new placements in
the US and RoW slowed down due to highly restricted access to
customers.
- New Idylla™ pandemic response test menu in H2
2020:
- Submission of the Idylla™ SARS-CoV-2 Test for Emergency Use
Authorization (‘EUA’) with the US FDA;
- Commercialization rights in Europe and RoW for the CE-marked
IVD test SeptiCyte® RAPID2 on Idylla™ from Immunexpress Pty Ltd3
('Immunexpress').
- Expanded oncology partnerships:
- Partnership with AstraZeneca expanded with a study on liquid
biopsy testing using the Idylla™ ctEGFR Mutation Assay (RUO4);
- New project with Bristol Myers Squibb Company (BMS) aimed at
pursuing the registration of the Idylla™ MSI Test as a companion
diagnostic5 (CDx) test in metastatic colorectal cancer (mCRC) in
China.
- Financials:
- Total operating income of EUR 17.6m (H1 2019: EUR 17.3m),
including EUR 11.4m product income (H1 2019: EUR 10.0m);
- Cash and cash equivalents of EUR 150m as per end H1 2020.
COVID-19 impact and 2020
outlookDespite the lingering impact of the pandemic,
particularly in the US and the RoW, we expect continued cartridge
volume growth with strong demand for the Idylla™ SARS-CoV-2 Test,
offsetting a temporary slowdown in the Idylla™ core oncology
business. Furthermore, the unique combined offering of the Idylla™
SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD) test on Idylla™
should fuel additional demand for Idylla™ instruments in the
hospital intensive care units6 (ICUs). Provided that (a) normal
business activities will resume in the course of H2 2020 and no new
widespread lock-down measures will be imposed, and (b) the Idylla™
SARS-CoV-2 Test is granted US FDA Emergency Use Authorization
(‘EUA’), Biocartis is reinstating its initial guidance for
2020:
- Targeting a year-over-year commercial cartridge volume growth
in the range of 30%, representing a volume of Idylla™ cartridges in
the range of 228k;
- Targeting an installed base growth in the range of 300-350 new
instrument placements; and
- Targeting a cash position in the range of EUR 110m by year-end
2020.
Biocartis will host a
conference call with live webcast presentation today at 15:00 CET /
14:00 BST (UK) / 09:00 EDT (US) to discuss the H1 2020 results.
Click here to access the live webcast. To participate in the
questions and answers session, please dial 5-10 minutes prior to
the start time the number +44 8445718892 (standard international),
followed by the confirmation code 6661855. The conference call and
webcast will be conducted in English. A replay of the webcast will
be available on the Biocartis investors’ website shortly after.
Commercial highlights
- Global – In H1 2020, despite the COVID-19 pandemic, the
commercial cartridge volume amounted to nearly 80k cartridges, a
year-over-year increase of 12%. After a strong Q1 2020, commercial
cartridge volumes in Q2 2020 were 20% lower than last year as a
direct consequence of the pandemic, which also limited new Idylla™
instrument placements to 101 in H1 2020.
- Europe – Cartridge volumes continued to grow in Europe that
also accounted for half of the new Idylla™ instruments placements.
The negative impact of the pandemic was most notable at the start
of Q2 2020, but the strength of the European customer base lead to
swift recovery with volumes and growth now tracking to initial
pre-pandemic expectations. Slower than expected cartridge growth in
the more affected Southern European countries was offset by robust
demand in the rest of Europe. The recent resurgence of COVID-19
cases across Europe may slow down the growth in H2 2020.
- US – Cartridge volume growth was strong in the US in Q1 2020,
but the recovery in Q2 2020 was less pronounced than in Europe as
many States are still battling with a high number of COVID-19
cases. Furthermore, COVID-19 measures did not allow new customer
prospection to labs, which stalled the growth of both Idylla™
installed base expansion and commercial cartridge volume in these
markets. The pandemic is expected to have a prolonged effect into
the second half of 2020.
- RoW – RoW cartridge growth was most impacted, with a COVID-19
peak that is still not reached in many regions. Latin America was
particularly affected. Nevertheless, new market authorizations were
obtained for the Idylla™ MSI Test in Colombia, Canada, Malaysia and
Singapore, and for the Idylla™ EGFR Mutation Test in
Argentina.
- Japan – Continued progress in the in vitro diagnostic (‘IVD’)
registration preparations for the Idylla™ assays are paving the way
to commercialization with Nichirei Biosciences in Japan, with first
test registrations to be expected earliest by end 2021.
- China – In China, the joint venture (‘China JV’) with Guangzhou
Wondfo Biotech Co., Ltd7 took further steps towards establishing
local manufacturing capabilities. Concerning the registration of
products, a first CDx partnership was announced on 5 March 2020
with Bristol Myers Squibb Company (BMS), aimed at pursuing the
registration in China of the Idylla™ MSI Test as a companion
diagnostic (CDx) test in metastatic colorectal cancer8 (mCRC) (see
below). First product registrations in China to be expected
earliest by end 2021.
Menu
and partnership highlights
- Partnership AstraZeneca – On 22 January 2020, Biocartis
announced that it entered into a master collaboration agreement
with AstraZeneca, a global science-led biopharmaceutical company
(LON/STO/NYSE: AZN), to enable collaborative development and
commercialization projects between Biocartis and AstraZeneca, such
as but not limited to, CDx development projects that may cover any
type of indication or biomarker. The first project in that context
is a study focused on evaluating if liquid biopsy testing using the
Idylla™ ctEGFR Mutation Assay (RUO) could provide further benefits
to tissue-based EGFR molecular testing.
- New BMS Immuno-Oncology MSI Project in China – On 5 March 2020,
Biocartis announced a new project under its existing collaboration
with Bristol-Myers Squibb Company (NYSE: BMY), a global
biopharmaceutical company. While the existing collaboration is
aimed at the registration in the US of the Idylla™ MSI Test as a
CDx test in metastatic colorectal cancer (mCRC), under the new
project, both partners will now also pursue the registration of the
Idylla™ MSI test as a CDx test in mCRC9 in the People’s Republic of
China.
- Expansion Immunexpress partnership – On 26 March 2020,
Biocartis announced the co-commercialization agreement with its
partner Immunexpress of the newly CE-marked IVD SeptiCyte® RAPID10
test on Idylla™, in which Biocartis will lead commercialization in
Europe as exclusive distributor of the SeptiCyte® RAPID test, while
Immunexpress will lead commercialization in the US. On 16 June
2020, Immunexpress announced to have been awarded a grant from the
Biomedical Advanced Research and Development Authority11
(‘BARDA’)12 for the SeptiCyte® RAPID13 test on Idylla™.
- Partnership Exact Sciences – COVID-19 led to the suspension of
the Idylla™ IVD Oncotype DX Breast Recurrence Score® test project.
Consequently, the project plan is under evaluation and timing is
under review. No launch is to be expected in 2020.
- Idylla™ publications, abstracts & posters – During H1 2020,
20 new Idylla™ publications, abstracts and posters14 were issued,
all demonstrating strong data of Idylla™ tests. The studies
included, amongst others, a new US multicenter study15 published in
the ‘American Journal of Clinical Pathology’ which showed that,
compared to current standard-of-care testing methods, the Idylla™
platform can substantially improve turnaround time of the results
of mutation testing, independent of the size of the laboratory. The
study is one of the largest studies performed involving Idylla™,
with 20 laboratories of different types and sizes included
throughout the US and Puerto Rico, and data from almost 800
colorectal cancer samples. Furthermore, during the virtual annual
ASCO16, five Idylla™ abstracts and posters17 were published by key
oncology opinion leaders, including first Idylla™ data from China
where amongst others the Idylla™ EGFR Mutation Assay (RUO) showed
excellent concordance with other methods.
Organizational and operational
highlights
- Appointment new CFO – On 23 April 2020, Biocartis announced the
appointment of Jean-Marc Roelandt as the new CFO of the Company
with immediate effect. Jean-Marc Roelandt is a senior executive
with an established track record of more than 25 years as CFO in
globally active publicly listed companies. With a focus on M&A,
capital market transactions and the implementation of adequate
financial management infrastructure in dynamic and fast growing
companies, he built up a solid expertise in various industries.
Prior to joining Biocartis, he was CFO of MDxHealth, a healthcare
company that provides actionable genomic information to personalize
the diagnosis and treatment of cancer.
- Progress on ML2 – Further progress was made on the transfer of
Idylla™ assays to the second cartridge manufacturing line (‘ML2’).
After the transfer of the Idylla™ KRAS Mutation Test (CE-IVD),
during H1 2020, the Idylla™ NRAS Mutation Test (CE-IVD) and the
Idylla™ MSI Test (CE-IVD) were successfully transferred to ML2. The
transfer of the EGFR Mutation Test (CE-IVD) is ongoing. The Idylla™
SARS-CoV-2 Test will initially be manufactured on the first
manufacturing line ‘ML1’, but the transfer to ML2 is planned
towards end 2020.
Post-period eventsThe following
events took place since 30 June 2020:
- US FDA EUA submission Idylla™ SARS-CoV-2 Test – On 10 August
2020, Biocartis notified US FDA of the intent to commercialize the
Idylla™ SARS-CoV-2 Test and applied for Emergency Use Authorization
(‘EUA’). The test is intended to detect SARS-CoV-2, the virus that
causes COVID-19, from nasopharyngeal swabs in viral transport
medium. The Idylla™ SARS-CoV-2 Test is targeted to help healthcare
providers manage the COVID-19 pandemic through rapid and easy
testing of individuals with flu-like symptoms. In addition, the
Idylla™ SARS-CoV-2 Test may be used in combination with the
recently CE-marked IVD SeptiCyte® RAPID18 test on Idylla™ to
facilitate management of patients within the hospital intensive
care unit (ICU). When used together, this combined testing solution
on Idylla™ has the unique potential to identify patients with
severe disease, as recent data19 indicate that sepsis is the most
frequently observed complication in COVID-1920. The US FDA
regulatory process of the SeptiCyte® RAPID test on Idylla™ is
ongoing. The development and roll-out of the Idylla™ SARS-CoV-2
Test is supported by multiple undisclosed partners as part of a
joint commitment to respond to the COVID-19 pandemic. Mobilizing
resources for the development of the Idylla™ SARS-CoV-2 Test
required certain other projects to be delayed, as described in the
menu outlook below. ‘Emergency Use Authorization’ (US) and
CE-marking (Europe) of the Idylla™ SARS-CoV-2 Test is pending.
- Expansion collaboration LifeArc – On 1 September 2020,
Biocartis announced the expansion of its collaboration with
LifeArc, a UK based independent medical research charity. The new
licence and development agreement is an extension of the existing
partnership21 between LifeArc and Biocartis. Under the new
agreement, LifeArc obtains a non-exclusive licence to use the
Idylla™ platform for the development of Idylla™ assays in the area
of infectious and immune related diseases, aimed at supporting
patient stratification and treatment monitoring of patients with,
amongst others, bacterial, fungal and viral infections.
Financial highlights
- Total operating income – Total operating income amounted to EUR
17.6m compared to EUR 17.3m last year. Product revenues increased
14% from EUR 10m in H1 2019 to EUR 11.4m in H1 2020. Within product
sales, cartridge sales revenues increased 28% on the back of 12%
higher volumes and an increasing average selling price. Idylla™
instrument sales revenues decreased by 26% as new placements were
hampered by the global COVID-19 measures. Following delays of
several partner projects, collaboration revenues of EUR 4.7m
decreased by EUR 2.1m year-on-year. H1 2019 also included a
licensing fee of EUR 2.5m.
- Gross profit – The cost of goods sold increased from EUR 8.7m
to EUR 9.2m, but the gross margin on product sales improved from
12% to 19% as increased cartridge volumes lowered the manufacturing
cost per cartridge.
- OPEX – Total operating expenses (including cost of sales) of
EUR 44m remained level with last year.
- Net cash flow and cash position – The net cash outflow from
operating and investing activities amounted to EUR 25.6m in H1 2020
compared to EUR 33.6m in H1 2019. The reduced outflow is
attributable to a lower investment in net working capital and lower
capital expenditure resulting from a lower number of Idylla™
instruments placed under reagent rental agreements. The cash and
cash equivalents at 30 June 2020 amounted to EUR 150m.
Key figures for H1 2020 The
tables below show an overview of the key figures and a breakdown of
operating income for H1 2020 and H1 2019. Consolidated financial
statements and accompanying notes are included in Biocartis’
half-year 2020 report that is available here on the Company’s
website.
Key figures (EUR 1,000) |
H1 2020 |
H1 2019 |
% Change |
Total operating income |
17,606 |
17,298 |
2% |
Cost of sales |
-9,233 |
-8,742 |
6% |
Research and development expenses |
-20,303 |
-20,031 |
1% |
Sales and marketing expenses |
-7,931 |
-8,811 |
-10% |
General and administrative expenses |
-6,491 |
-6,399 |
1% |
Operating expenses |
-43,958 |
-43,983 |
0% |
Operating result |
-26,352 |
-26,685 |
-1% |
Net financial result |
-5,129 |
-2,822 |
82% |
Share in the result of associated companies |
-195 |
-181 |
8% |
Income tax |
118 |
18 |
556% |
Net result |
-31,558 |
-29,670 |
6% |
Cash flow from operating activities |
-24,526 |
-28,357 |
-14% |
Cash flow from investing activities |
-1,028 |
-5,267 |
-80% |
Cash flow from financing activities |
-3,456 |
179,465 |
-102% |
Net cash flow 1 |
-29,010 |
145,841 |
-120% |
Cash and cash equivalents2 |
149,674 |
209,200 |
-28% |
Financial debt |
165,258 |
166,578 |
-1% |
1 Excludes the effect of exchange rate
differences on the cash balances held in foreign currencies2
Including EUR 1.2m of restricted cash in H1 2020 and H1 2019
Operating income (EUR 1,000) |
H1 2020 |
H1 2019 |
% Change |
Collaboration revenue |
4,746 |
6,816 |
-30% |
Idylla™ system sales |
1,837 |
2,499 |
-26% |
Idylla™ cartridge sales |
9,584 |
7,481 |
28% |
Product sales revenue |
11,421 |
9,980 |
14% |
Service revenue |
530 |
351 |
51% |
Total revenue |
16,697 |
17,147 |
-3% |
Grants and other income |
909 |
151 |
502% |
Total operating income |
17,606 |
17,298 |
2% |
Product sales revenue (EUR 1,000) |
H1 2020 |
H1 2019 |
% Change |
Commercial revenue |
10,491 |
9,551 |
10% |
Research & development revenue |
930 |
429 |
117% |
Total product sales revenue |
11,421 |
9,980 |
14% |
Outlook
- Commercial cartridge volume: Targeting a year-over-year
commercial volume growth in the range of 30%, representing a volume
of Idylla™ cartridges in the range of 228k.
- Idylla™ installed base: Targeting an installed base growth in
the range of 300-350 new Idylla™ instruments placements.
- Idylla™ test menu outlook: COVID-19 impacted and delayed
various partner projects. Furthermore, mobilizing resources for the
development of the Idylla™ SARS-CoV-2 Test affected the planning of
certain other projects. The revised test menu outlook is now as
follows:
- ONCOLOGY MENU:* Colorectal cancer menu – Subject to further
feedback from US FDA interaction, US FDA 510(k) submission of the
Idylla™ MSI Test is expected in Q4 2020 and US FDA submission of
PMA (Pre-Market Approval) application for the Idylla™ RAS tests is
now expected in H1 2021 (instead of end 2020 initially);* Lung
cancer menu – Minor delay of the RUO launch of the Idylla™
GeneFusion Assay to Q1 2021 (instead of end 2020 initially);*
Breast cancer menu – The plan for the Idylla™ IVD Oncotype DX
Breast Recurrence Score® test is under evaluation and timing is
under review. No launch to be expected in 2020.
o INFECTIOUS
DISEASE PARTNER MENU: * The
CE-IVD market release of the SeptiCyte® RAPID test on Idylla™ is
expected in Q3 2020 and the US FDA regulatory process is
ongoing; * Emergency Use
Authorization ('EUA’) (US) and CE-marking (Europe) of the Idylla™
SARS-CoV-2 Test is pending. Financial calendar
2020
- 12 November 2020 Q3 2020 Business
Update
- 12 November 2020 Capital Markets Day 2020
(virtual or physical event, depending on Belgian COVID-19
guidelines)
- 25 February 2021 2020 full
year results
- 1 April
2021
Publication 2020 annual report
Auditor Statement
The condensed consolidated financial statements
for the six-months’ period ended 30 June 2020 have been prepared in
accordance with IAS 34 ‘Interim Financial Reporting’ as adopted by
the European Union. They do not include all the information
required for the full annual financial statements and should
therefore be read in conjunction with the financial statements for
the year ended 31 December 2019. The condensed consolidated
financial statements are presented in thousands of Euros (unless
stated otherwise). The condensed consolidated financial statements
have been approved for issue by the Board of Directors. The
statutory auditor, Deloitte Bedrijfsrevisoren/Reviseurs
d’Entreprises, represented by Nico Houthaeve, has performed a
review, which did not reveal any significant adjustments to the
condensed consolidated financial statements. The interim financial
report 2020 and the review opinion of the auditor are available on
www.biocartis.com.
--- END ---
More information:
Renate Degrave Head of Corporate Communications & Investor
Relations Biocartis e-mail rdegrave@biocartis.com
tel +32 15 631 729
mobile +32 471 53 60 64
About Biocartis
Biocartis (Euronext Brussels: BCART) is an
innovative molecular diagnostics (MDx) company providing next
generation diagnostic solutions aimed at improving clinical
practice for the benefit of patients, clinicians, payers and
industry. Biocartis' proprietary MDx Idylla™ platform is a fully
automated sample-to-result, real-time PCR (Polymerase Chain
Reaction) system that offers accurate, highly reliable molecular
information from virtually any biological sample in virtually any
setting. Biocartis is developing and marketing a continuously
expanding test menu addressing key unmet clinical needs, with a
focus in oncology, which represents the fastest growing segment of
the MDx market worldwide. Today, Biocartis offers tests supporting
melanoma, colorectal and lung cancer. More
information: www.biocartis.com. Follow us on Twitter:
@Biocartis_.
Biocartis and Idylla™ are registered trademarks
in Europe, the United States and other countries. The Biocartis and
Idylla™ trademark and logo are used trademarks owned by Biocartis.
This press release is not for distribution, directly or indirectly,
in any jurisdiction where to do so would be unlawful. Any persons
reading this press release should inform themselves of and observe
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violation of any such restrictions by any person. Please refer to
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individual Biocartis product. This press release does not
constitute an offer or invitation for the sale or purchase of
securities in any jurisdiction. No securities of Biocartis may be
offered or sold in the United States of America absent registration
with the United States Securities and Exchange Commission or an
exemption from registration under the U.S. Securities Act of 1933,
as amended.
Forward-looking statements
Certain statements, beliefs and opinions in this
press release are forward-looking, which reflect the Company's or,
as appropriate, the Company directors' or managements' current
expectations and projections concerning future events such as the
Company's results of operations, financial condition, liquidity,
performance, prospects, growth, strategies and the industry in
which the Company operates. By their nature, forward-looking
statements involve a number of risks, uncertainties, assumptions
and other factors that could cause actual results or events to
differ materially from those expressed or implied by the
forward-looking statements. These risks, uncertainties, assumptions
and factors could adversely affect the outcome and financial
effects of the plans and events described herein. A multitude of
factors including, but not limited to, changes in demand,
competition and technology, can cause actual events, performance or
results to differ significantly from any anticipated development.
Forward-looking statements contained in this press release
regarding past trends or activities are not guarantees of future
performance and should not be taken as a representation that such
trends or activities will continue in the future. In addition, even
if actual results or developments are consistent with the
forward-looking statements contained in this press release, those
results or developments may not be indicative of results or
developments in future periods. No representations and warranties
are made as to the accuracy or fairness of such forward-looking
statements. As a result, the Company expressly disclaims any
obligation or undertaking to release any updates or revisions to
any forward-looking statements in this press release as a result of
any change in expectations or any change in events, conditions,
assumptions or circumstances on which these forward-looking
statements are based, except if specifically required to do so by
law or regulation. Neither the Company nor its advisers or
representatives nor any of its subsidiary undertakings or any such
person's officers or employees guarantees that the assumptions
underlying such forward-looking statements are free from errors nor
does either accept any responsibility for the future accuracy of
the forward-looking statements contained in this press release or
the actual occurrence of the forecasted developments. You should
not place undue reliance on forward-looking statements, which speak
only as of the date of this press release.
1 RoW = Rest of the World. RoW is defined as the world excluding
European direct markets, US, China and Japan
2 Developed in collaboration with Immunexpress. More info
here
3 Immunexpress is a molecular diagnostic company focused on
improving outcomes for suspected sepsis patients
4 RUO = Research Use Only, not for use in
diagnostic procedures
5 An IVD companion diagnostic device is an in vitro diagnostic
device that provides information that is essential for the safe and
effective use of a corresponding therapeutic product. Source: US
FDA, last consulted on 6 August 2020
6 The Idylla™ SARS-CoV-2 Test and the SeptiCyte® RAPID (CE-IVD)
test on Idylla™ are intended for use in microbiology labs
7 Wondfo’, SHE: 300482, a fast growing diagnostics leader in
China
8 More info on
https://investors.biocartis.com/sites/default/files/press-releases/2020/200304_pr_bms_china_eng_final.pdf
9 mCRC = metastatic colorectal cancer
10 The SeptiCyte® RAPID test is a rapid, host-response test that
distinguishes sepsis from non-infectious SIRS (systemic
inflammatory response syndrome) and is expected to provide
actionable results in about one hour. Host-response based tests
focus on measuring biomarkers that are indicative of the response
of a patient’s immune system to an infection rather than measuring
pathogens that are the cause of the infection. Moreover, the
SeptiCyte® RAPID test not only discriminates sepsis from SIRS but
also correlates with viral sepsis infection, versus procalcitonin
(PCT) which increases with severity of bacterial but not viral
infection and is also a non-specific marker of inflammation
11 Part of the Office of the Assistant Secretary
for Preparedness and Response at the U.S. Department of Health and
Human Services (HHS). More info here
12 More info
here
13 The SeptiCyte® RAPID test is a rapid, host-response test that
distinguishes sepsis from non-infectious SIRS (systemic
inflammatory response syndrome) and is expected to provide
actionable results in about one hour. Host-response based tests
focus on measuring biomarkers that are indicative of the response
of a patient’s immune system to an infection rather than measuring
pathogens that are the cause of the infection. Moreover, the
SeptiCyte® RAPID test not only discriminates sepsis from SIRS but
also correlates with viral sepsis infection, versus procalcitonin
(PCT) which increases with severity of bacterial but not viral
infection and is also a non-specific marker of inflammation
14 Including e-publications ahead of print.
Sources: (1) Merlin MS et al. Rapid fully-automated assay for
routine molecular diagnosis of BRAF mutations for personalized
therapy of low grade gliomas. Pediatr Hematol Oncol. 2020
Feb;37(1):29-40; (2) De Luca C et al. Rapid On-site Molecular
Evaluation in thyroid cytopathology: A same-day cytological and
molecular diagnosis. Diagn Cytopathol. 2020 Apr;48(4):300-30. Epub
2020 Jan 6; (3) Lee et al. Reduced sensitivity for EGFR T790M
mutations using the Idylla EGFR Mutation Test. J Clin Path. May
2020; (4) Lassalle et al. Targeted Assessment of the EGFR Status as
Reflex Testing in Treatment-Naive Non-Squamous Cell Lung Carcinoma
Patients: A Single Laboratory Experience (LPCE, Nice, France).
Cancers 2020, 12, 955. April 2020; (5) Delgado-Garcia et al.
Clinical performance evaluation of the Idylla™ EGFR Mutation Test
on formalin-fixed paraffin-embedded tissue of non-small cell lung
cancer. BMC Cancer volume 20, Article number: 275, April 2020. Epub
ahead of print; (6) Al-Turkmani et al. Rapid EGFR mutation testing
in lung cancer tissue samples using a fully automated system and
single-use cartridge. Practical Laboratory Medicine 20 (2020); (7)
Boureille A et al. Rapid detection of EGFR mutations in decalcified
lung cancer bone metastasis. Bone Oncol. 2020 Jan Epub ahead of
print; (8) Chevalier L et al. EGFR molecular characterization in
non-small cell bronchic cancer: comparative prospective study by
NGS and Idylla platform technologies. Annales de Pathologie. Feb
2020; (9) Bocciarelli C. et al. Evaluation of the Idylla system to
detect the EGFRT790M mutation using extracted DNA. Pathol Res
Pract. 2020 Jan;216 (1); (10) Sousa et al. Detection of rare and
novel EGFR mutations in NSCLC patients: Implications for
treatment-decision. Lung Cancer. 2020 Jan;139: 35-40; (11)
Gralewski J et al. Detection of EGFR Exons 18-21 Hotspot Mutations
Using a Fully-Automated, Cartridge-Based Platform with Ultra-Rapid
Turnaround Time: A Comparison Study with Conventional Next
Generation Sequencing. USCAP 2020; (12) Gadde R et al. Validation
of the Idylla™ EGFR Assay for Rapid Assessment of EGFR Mutation
Status in Non-small Cell Lung Cancer. USCAP 2020; (13) Matthews P
et al. The impact of in-house biomarker testing on NSCLS patients.
USCAP 2020; (14) Pécriaux et al. Detection of Microsatellite
Instability in a Panel of Solid Tumours With the Idylla MSI Test
Using Extracted DNA. J Clin Pathol 2020 June; (15) Yaziji H et al.
Validation of a Rapid PCR Assay for Microsatellite Instability
Testing in Colorectal Cancer. USCAP 2020; (16) Dagenborg et al.
Neoadjuvant Chemotherapy Is Associated With a Transient Increase of
Intratumoral T-cell Density in Microsatellite Stable Colorectal
Liver Metastases. Cancer Biol Ther . 2020 May 3;21(5):432-440; (17)
Zwaenepoel K et al. Clinical Performance of the Idylla MSI Test for
a Rapid Assessment of the DNA Microsatellite Status in Human
Colorectal Cancer. J Mol Diagn. March 2020; 22 (3): 386-395. Epub
ahead of Print Dec 2019; (18) Vessies et al. Performance of Four
Platforms for KRAS Mutation Detection in Plasma Cell-Free DNA:
ddPCR, Idylla, COBAS z480 and BEAMing. Sci Rep. 2020 May
15;10(1):8122; (19) Franczak C et al. Evaluation of KRAS, NRAS and
BRAF mutations detection in plasma using an automated system for
patients with metastatic colorectal cancer. PLoS One. 2020 Jan 15;
(20) Tsongalis et al., “Comparison of Tissue Molecular Biomarker
Testing Turnaround Times and Concordance Between Standard of Care
and the Biocartis Idylla Platform in Patients With Colorectal
Cancer”, Am J Clin Pathol. 2020 Jun 11;aqaa044. doi:
10.1093/ajcp/aqaa044. Online ahead of print. See also
www.biocartis.com/publications
15 Led by researchers from Dartmouth’s and
Dartmouth-Hitchcock’s Norris Cotton Cancer Center (Lebanon, New
Hampshire, US). Tsongalis et al., “Comparison of Tissue Molecular
Biomarker Testing Turnaround Times and Concordance Between Standard
of Care and the Biocartis Idylla Platform in Patients With
Colorectal Cancer”, Am J Clin Pathol. 2020 Jun 11;aqaa044. doi:
10.1093/ajcp/aqaa044. Online ahead of print
16 American Society of Clinical Oncology
meeting, took place between 8-10 August 2020
17 R. Gadde et al., ‘Validation of the Idylla™
EGFR Assay for Rapid Assessment of EGFR Mutation Status in
Non-small Cell Lung Cancer’, Dartmouth Hitchcock Medical Center,
Lebanon, NH; H Yaziji et al., ‘Validation of a Rapid
PCR Assay for Microsatellite Instability Testing in Colorectal
Cancer’, Vitro Molecular Laboratories, Miami, FL; J Gralewski et
al., ‘Detection of EGFR Exons 18-21 Hotspot Mutations Using a
Fully-Automated, Cartridge-Based Platform with Ultra-Rapid
Turnaround Time: A Comparison Study with Conventional Next
Generation Sequencing’, University of New Mexico, Albuquerque, NM;
P. Matthews et al., ‘Clinical Impact of Rapid Biomarker Testing in
Non-Small Cell Lung Cancer in a Community Setting’, William Osler
Health System, Brampton, ON, Canada
18 Developed in collaboration with Immunexpress.
More info here
19 Zhou et al., Clinical course and risk factors
for mortality of adult inpatients with COVID-19 in Wuhan, China: a
retrospective cohort study, published online 9 March 2020,
https://doi.org/10.1016/S0140-6736(20)30566-3
20 Sepsis developed at a median of 9 days (7–13)
after illness onset among all patients, followed by ARDS (12 days
[8–15]), acute cardiac injury (15 days [10–17]), acute kidney
injury (15 days [13–19.5]), and secondary infection (17 days
[13–9])
21 In June 2017, Biocartis announced a
partnership with LifeArc to develop selected molecular diagnostic
tests for use on the Idylla™ platform. For each selected test,
LifeArc will act as a development contractor, whereas Biocartis
will be responsible for the commercialization of the tests under
its own label. More info on www.biocartis.com/partners. On 15 June
2017, MRC Technology changed its name to LifeArc. LifeArc has been
involved in helping deliver a number of therapies including
Keytruda® (pembrolizumab, marketed by Merck) which is an important
immunotherapy treatment for various cancers. The collaboration
between Biocartis and LifeArc today is focused on the development
and the commercialization of the Idylla™ ABC (Advanced Breast
Cancer) assay. This assay is positioned to target a multi-gene
panel of predictive and resistance-inducing mutations based on a
FFPE sample type
Grafico Azioni Biocartis Group NV (EU:BCART)
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Grafico Azioni Biocartis Group NV (EU:BCART)
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