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BioPorto Diagnostics

NGAL test hits a snag at FDA

Update | Pharmaceutical & healthcare | 09 Oct 2018

BioPorto announced on 3 October 2018 that it had received feedback from the FDA on its outstanding 510(k) application for The NGAL Test for risk use with acute kidney injury (AKI). The agency said that additional data would be required to support a ‘rule-out’ claim (ie that the test can exclude the risk of AKI). The company is engaged in discussions with the agency and has revised its timeline: an FDA decision in mid-2019.

BioPorto Diagnostics

Retrospective paediatric AKI study initiated

Update | Pharmaceutical & healthcare | 03 Oct 2018

BioPorto announced that it would be initiating a pilot study for the detection of paediatric acute kidney injury (AKI). The study will be a retrospective analysis of urine collected from paediatric ICU patients in an earlier study. We expect the results from this analysis to potentially support an additional 510(k) application for this population if The NGAL Test is approved for adults. The results are expected in H119.

BioPorto Diagnostics

Altering the paradigm for kidney injury

Initiation | Pharmaceutical & healthcare | 22 Aug 2018

BioPorto is a commercial-stage diagnostic company with a portfolio of antibodies and other products sold for research and diagnostic purposes. However, its lead strategic goal is development of a test for acute kidney injury (AKI) using the biomarker NGAL. The test should provide superior results to the standard of care (serum creatinine, sCr) in two hours versus 24 hours or more. We initiate at DKK1,078m or DKK6.93 per share.

ReNeuron Group

The rise of the exosome

Update | Pharmaceutical & healthcare | 22 May 2018

ReNeuron introduced its exosome nanomedicine programme at its recent capital markets day. While being a preclinical programme, it has three significant advantages. First, it gives ReNeuron the potential to expand into new therapeutic indications. Second, it opens up the potential for collaborations in diagnostics and drug delivery. Third, it builds on its wealth of experience and IP and on its CTX cell line on which ReNeuron’s existing products and the exosome platform are built.

Curetis NV

Executive interview - Curetis NV

Edison TV: | Pharmaceutical & healthcare | 02 Mar 2018

Founded in 2007, Curetis is a developer of next-level molecular diagnostic solutions. Curetis focuses on the research, development and commercialisation of dependable, timely and cost-effective products that can be used to diagnose severe infectious diseases. The diagnostic achievements and progress the company is making enable rapid, multi-parameter pathogen and antibiotic resistance marker detection. It has designed the Unyvero platform, a fast, comprehensive diagnostics system that analyses severe infectious diseases in hospitalized patients. Using an array of cartridges, infectious diseases such as pneumonia or implant/tissue infections can be easily and rapidly diagnosed. While the current standard of diagnosis can take days or even weeks, Curetis can typically diagnose in four to five hours, either in a hospital laboratory or directly at the "point of need" in the intensive care unit.

Pacific Edge

Anticipating commercial growth

Outlook | Pharmaceutical & healthcare | 09 Jan 2018

Pacific Edge continues to make progress commercialising its suite of bladder cancer diagnostics products, with three tests currently available in the US market. An uplift in sales is expected as TRICARE and the Veterans Administration (VA) are under contract, although the exact timing of a sales ramp is unknown. In addition, the company’s discussions with Kaiser Permanente are nearing a final decision and progress has been made with achieving inclusion in the local coverage determination (LCD) by the US Centers for Medicare and Medicaid Services (CMS).


Massive fatty liver opportunity

Review | Pharmaceutical & healthcare | 15 Dec 2017

One Way Liver (OWL), a private company, sells a non-invasive sophisticated lab diagnostic (OWLiver) to detect liver inflammation. The obesity epidemic means that millions of people across the EU and the US have non-alcoholic steatohepatitis (NASH) that can lead to liver fibrosis. The initial market is seen as private US patients with sales though a marketing partner from 2018. OWL plans direct European sales and has some local reimbursement in Spain. New NASH therapeutics could be approved over the next few years but these need a diagnostic to identify patients; OWL is working with a number of companies on their NASH clinical trials. OWLiver could become the lead diagnostic for this potentially huge new market. A specific fibrosis test (OWLFiber) is in development for 2018 launch.


Executive interview - NetScientific

Edison TV: | Pharmaceutical & healthcare | 11 Oct 2017

NetScientific is a healthcare investment company with a focused portfolio of potentially disruptive biomedical and healthcare technology investments. The current focus is on digital health, diagnostics and therapeutics with the portfolio consisting of four core investments in which it has controlling stakes (Vortex, Wanda, ProAxsis and Glycotest) and one material investment (PDS). The aim is to bring these to commercialisation over the next two years, with the ultimate goal of an exit, realising value for investors.


Milestone in ovarian cancer application

Flash note | Pharmaceutical & healthcare | 05 Jul 2017

This morning Angle reported initial results from its two lead clinical trials with Parsortix, a liquid biopsy system. The two studies ran in parallel in Europe (ANG-001) and the US (ANG-003) and explored Parsortix's efficacy in triaging women with ovarian masses before surgery ie looking at whether the tumour is benign or malignant to estimate the extent of the necessary surgery. Both studies recruited 200 patients each and reported sensitivity was up to 95%, while specificity was much higher than existing tests. Angle has refrained from releasing further data, as it believes that the diagnostic algorithms (combining Parsortix findings, RNA markers and patient data) that were developed during the trials could be patented.

Pacific Edge

A growth year

Update | Pharmaceutical & healthcare | 01 Jun 2017

Pacific Edge continues to make progress in the commercialisation of its bladder cancer diagnostics tests, reporting 35% growth in the number of tests analysed and a 62% increase in operating revenue. The potential for a significant sales ramp exists as TRICARE and the Veterans Administration (VA) are now under contract and expected to come online commercially in FY18. Also, discussions with Kaiser Permanente are nearing conclusion and progress has been made with the Centers for Medicare and Medicaid Services (CMS) on the reimbursement front.


Building momentum toward break-even

QuickView | Pharmaceutical & healthcare | 28 Apr 2017

Novacyt reported FY16 results on 27 April. Headline sales announced in January showed that total FY16 sales grew 25% y-o-y to €11.1m (38% at a constant exchange rate, CER). The acquisition of Primerdesign (consolidated from May 2016) added to total group H216 sales, which grew an impressive 47% (68% at CER) y-o-y. Novacyt's earnings showed that sales growth was accompanied by a substantial expansion in gross margin from 48.1% in FY15 to consolidated 54.9% in FY16 or 59.0% pro forma. All this boosted consolidated EBITDA close to break-even at -€0.7m in H216 versus €1.6m in H116. We find the combination of a continuing high growth trend and near break-even EBITDA comforting and supportive for the share price.


Innovative clinical diagnostics

QuickView | Pharmaceutical & healthcare | 21 Mar 2017

Novacyt is a high growth diagnostics company that has developed innovative technology platforms specifically in liquid-based cytology (LBC) testing and new-generation molecular products based on real-time quantitative polymerase chain reaction (qPCR). Novacyt also has an established manufacturing and global distribution channel, which offers a wide range of profitable infectious disease diagnostic products. 2017 could be a transformative year, as the integration of recent acquisitions helps accelerate sales momentum of its key products NOVAprep (LBC) and Primerdesign's genesig (qPCR). By targeting wider markets the company aims to achieve EBITDA break-even in 2017.