diagnostics

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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).

OWL

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.

NetScientific

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.

Angle

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.

Novacyt

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.

Novacyt

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.

VolitionRx

Something innovative in the state of Denmark

Update | Pharmaceutical & healthcare | 20 Mar 2017

VolitionRx recently announced the initiation of a two-phase logistical study for its Nu.Q™ Triage test for colorectal cancer (CRC) in Denmark, which may enable the inclusion of the test in the country's national screening program in conjunction with the standard fecal immunochemical test (FIT). The study is expected to take six months to complete with the potential for a decision by the national screening committee by the end of the year. If included, the Nu.Q™ Triage test would be the first blood-based cancer diagnostic as part of a national screening program for CRC.

Pacific Edge

Launches continue to progress

Update | Pharmaceutical & healthcare | 13 Feb 2017

Pacific Edge continues to make progress in the commercialisation of its bladder cancer diagnostics tests in the US, with three tests currently available in the US market. The company signed a contract with Tricare, which handles the healthcare for uniformed service members and their families, and successfully completed a User Programme with Kaiser Permanente (KP), validating the performance of the Cxbladder Triage and the Cxbladder Detect tests. Additionally, the company’s newest test, Cxbladder Resolve, has been launched in New Zealand.

Immunovia

Getting the immune system to work in diagnostics

Initiation | Pharmaceutical & healthcare | 10 Nov 2016

Immunovia is ready to validate its test for the early diagnosis of pancreatic cancer from its IMMray platform. Pancreatic cancer is rare and difficult to treat, with a five-year survival rate of c 5%; early diagnosis could improve this to c 50%. This would make an accurate diagnostic test cost-effective in higher-risk patient groups. A prospective trial will start in Q416, with first out-of-pocket sales in 2018 before reimbursement is achieved. Screening of patients newly diagnosed with type 2 diabetes provides additional upside. We value Immunovia at SEK2.6bn or SEK155.2/share.

Stratec Biomedical

Digesting acquisitions after Chinese hiccup

QuickView | Pharmaceutical & healthcare | 09 Nov 2016

Stratec, a designer and builder of automated OEM diagnostic systems made two acquisitions during 2016. The first (from April), was Diatron, a leading Hungarian OEM manufacturer of differential haematology analysers; 2015 sales were €34m. The second (from July), was DADC, now Stratec Consumables (SC). SC (which is Austrian) designs and manufactures precision consumables for high-end diagnostic systems; 2016 sales may be €17m. Core Stratec sales in 2016 will be affected by a slowdown in China. Guidance is for total 2016 sales of €175-182m and €205-220m in 2017. 2016 EBIT margin should be 16-17% rising slightly in 2017.

NetScientific

Executive Interview - NetScientific

Edison TV: | Pharmaceutical & healthcare | 08 Nov 2016

NetScientific is a healthcare investment company with a portfolio of digital health, diagnostic and therapeutic investees. In 2015 the company realigned its investment strategy, bringing a new highly experienced CEO on board and rationalising the portfolio and new funding (£18.2m gross from the issue of 15.2m new shares at 120p) to accelerate development in some of its key holdings. A series of value inflection points are expected in what remains of 2016 and 2017 including Series A financing for four holdings, the commercial ramp up of the Wanda digital health platform and the launch of the Vortex liquid biopsy product.