According to Yole Développement, microfluidic-based point-of-care (POC) diagnostic market size will reach $13.2B by 2023 (up from $4B in 2017), growing at a CAGR of 23% from 2017 – 2023. In 2017 emergency testing was the leading segment, and its dominance is expected to continue throughout the forecast period.
Advances in miniaturization, batteries, and molecular diagnostics will see POC tests proliferate beyond traditional care settings (hospitals and doctor’s offices) and into homes, representing a market value of $129M by 2023 (Point-of-Need Testing: Application of Microfluidic Technologies 2018 report).
In 2018 North America will continue as market leader, while a growing number of actors in the POC diagnostic industry will remain highly focused on expanding their business operations via new product launches in emerging, fast-growing countries.
Yole’s MedTech experts Sebastien Clerc and Asma Siari, recently had the opportunity to interview Patrice Allibert, CEO of GenePOC one of the field’s key players. To follow is a summary of their discussion:
Sebastien Clerc (S.C): Can you recap GenePOC’s history, from the company’s founding through to present-day?
Patrice Allibert (P.A): GenePOC was founded in 2007 by Dr. Michel G. Bergeron, a globally-recognized biomolecular scientist. The first employees joined GenePOC in 2012 and worked hard to build the company’s foundations. Only two years later, GenePOC had 35 employees and received its ISO Certification 13485. In July 2016, Debiopharm Group invested several million dollars in the company, allowing GenePOC to continue growing and launch its first assay on the market: GenePOC GBS LB, after obtaining the CE-mark and FDA clearance.
Today, GenePOC has around 100 employees, most of whom are located at our Quebec City headquarters. The rest are distributed between the USA and Belgium to support sales and distribution. GenePOC has launched three assays and an instrument for molecular diagnosis of infectious disease in the US, EU, and Canadian markets, and has contracts with more than 15 distributors in order to achieve broad, successful commercialization.
Asma Siari (A.S): Could you share with us the financial requirements and development time needed to commercialize your platform?
P.A: Finding financing was difficult, but we persevered and in December 2014 I finally convinced the aforementioned Debiopharm Group, a pharmaceutical company based in Switzerland, to invest in our Canadian startup.
The GenePOC assay’s pre-development was done externally and then reinternalized in GenePOC’s labs for final development. The GenePOC team mastered and then conducted pre-clinical and clinical studies within a window of 4 – 7 months per assay, depending on the pathology involved. For the instrument revogeneTM and the first two tests (GBS LB and Cdiff), GenePOC obtained FDA clearance in less than 90 days.
S.C: Can you highlight the technology behind the revogene system and detail the current IVD test menu and upcoming tests? What is the purpose of these tests, and who are the users?
P.A: The revogene system uses real-time polymerase chain reaction (PCR) technology in combination with unique test cartridges called PIEs. Each PIE is a closed microfluidic system, where sample homogenization, lysis/dilution, and DNA amplification steps are done. One PIE contains three independent PCR wells, and the revogene can read four colors, offering the possibility to detect up to 12 genetic targets. The GenePOC system is a powerful tool that can treat almost any specimen type (blood, urine, stool, vagina/throat swabs), while offering unique ease-of-use and flexibility, allowing labs to run 1 – 8 different samples simultaneously.
GenePOC has recently launched three assays on the market:
GenePOC GBS LB, for Group B Streptococcus (GBS) detection in pregnant women. Because GBS remains the world’s leading cause of neonatal sepsis and meningitis, the CDC recommends universal antepartum screening for GBS colonization at 35 – 37 weeks of gestation, along with intrapartum antibiotic prophylaxis.
The second assay (launched in Europe only) was GenePOC GBS DS, also for GBS detection, but this time at the moment of delivery. The nurse takes a vaginal/rectal swab from the woman and performs the test directly in the ward (at point-of-care). This rapid screening provides a quick answer on the woman’s GBS status, confirming whether or not treatment is necessary to prevent an infection in the baby.
The third test is GenePOC CDiff, for the detection of the toxin B gene of Clostridium difficile bacteria. In the United States, this bacteria causes more deaths than car accidents. This bacterium is present on the human intestinal flora and can overgrow after an antibiotic therapy. If this happens it can cause an infection, including diarrhea and severe illness. One of the goals here, besides the treatment, is to quickly identify the infected patient and avoid contaminating other patients in the hospital.
GenePOC will continue developing new assays (two per year) to quickly diagnose infectious diseases, with the aim to fight antimicrobial resistance. The next two assays will be GenePOC Strep A and C/G + GenePOC Carba.
A.S: The field of molecular diagnostics is very dynamic, and the competition looks strong. How must GenePOC position itself in order to gain a competitive advantage? What are the main hurdles?
P.A: Diagnosis represents only a very small percentage of total health costs. In fact, in the hospital setting it represents only 1% – 2% of costs. However, laboratory test results influence 70% of therapeutic decisions. When laboratories are centralized, patients are often forgotten, and although laboratories pride themselves on a quick turnaround time, this often doesn’t include all the steps involved in generating an actionable patient result. Indeed, the choice of laboratory equipment and technology is only rarely derived from the need to add more flexibility in being more patient-centric, since it is perceived to raise cost of acquisition.
Source: Point-of-Need Testing: Application of Microfluidic Technologies 2018 report, Yole Développement
GenePOC’s solution is to simplify processes and accelerate molecular testing at a lower total cost. Advanced PCR methods, along with microfluidics-based emerging disruptive technologies, are driving low-cost, “sample-to-result,” miniaturized device development, providing groundbreaking platforms for applications in infectious disease point-of-care testing (POCT). Anticipating this medical need, GenePOC developed the revogene: a compact, automated, stand-alone instrument that is well-suited for on-the-spot molecular diagnostic testing. It offers good performance and flexibility for an optimal testing workflow.
Source: Point-of-Need Testing: Application of Microfluidic Technologies 2018 report, Yole Développement
S.C: Over the last few years, numerous molecular diagnostics companies have been acquired by bigger companies: IQuum by Roche, BioFire by bioMérieux, Nanosphere by Luminex, Cepheid by Danaher, etc. GenePOC also received a significant investment from Debiopharm in 2016. Can you comment on these companies’ strategies?
P.A: Most of the top 10 diagnostic companies are extending their technology portfolio through external acquisition. In the Molecular Diagnostics area, BD was the “acquisition pioneer” with GeneOhm in 2004. Developing new technologies in startup companies, and using their IP, offers the acquiring company much greater flexibility and efficiency. For all of these companies, the acquisition was driven by a need to extend their penetration in a specific segment. Danaher’s acquisition of Cepheid followed a different strategy than most. In this instance, Danaher acquired a mature business with the goal of significantly increasing Cepheid’s business margin in the ensuing years. On a separate note, it is interesting that GenePOC is the only non-US company on your list!
A.S: In your opinion, how will the molecular diagnostic industry be impacted by the emergence of new POC devices? How will the regulatory landscape evolve?
P.A: I believe that the molecular diagnostic industry will evolve as a consequence of more rapid, easier-to-use technology that’s entering the market for diagnosis of infectious diseases. The reality is that the benefits associated with molecular POC devices are superior to the more traditional molecular testing methods, which are less flexible and take more time to generate results. POC molecular devices have huge potential for improving various healthcare systems by reducing the window of diagnostic impact – especially for infectious diseases.
Why is this important? Because by having a device closer to the patient and reducing result delivery time, we also reduce the risk of infection transmission and patient outbreaks within the community or the hospital. This further allows for reducing the need for contact isolation (and other expensive counter-measures) and shifting the focus to the patient and the proper course of treatment, delivered faster and avoiding costly patient complications. All of this is coupled with the fact that infections are the next big threat to human health, and the fact that the pharmaceutical industry is lagging in bringing novel antimicrobial agents to face this threat. So, having readily-accessible POC molecular diagnostics will shift infectious disease diagnosis away from specialized molecular or microbiology labs and into patient wards, clinics, and even local pharmacies.
Regulatory must also evolve in providing the proper guidelines to favor use of these newer beneficial technologies over less-sensitive methods. The latter are prone to false diagnosis and also increase the misuse of antimicrobial agents, which in turn increases the threat of infectious diseases that compromise human health. The fact that we are talking about molecular technology at the point-of-care will also change the perceived weakness of POC technology as something that doesn’t offer the same quality of results as central laboratory diagnostic tests.
S.C: What are your expectations for GenePOC in 2018? Where do you see the company in five or ten years?
P.A: 2018 will be GenePOC’s first year of sales. We expect to sign a significant number of sales contracts with customers and become a well-known, recognized company. There is a global need for a small-footprint system that stresses affordability and ease of use. This system must be capable of supporting the entire infectious diseases menu, including hospital-acquired infections (HAI), sexually-transmitted diseases (STDs), gastro and respiratory panels, individual as well as multiplex targets, DNA and RNA, etc. The winning companies will be the ones with the technology capable of managing all sample types and lysing of all bug varieties.
GenePOC will obviously be one of the winners because our PIE and revogene include everything required to be successful. This belief has been echoed by Frost & Sullivan, which has twice awarded GenePOC (in 2013 and 2017) for innovative technology.
In the next five years we see GenePOC among the top three for near-patient molecular testing, and in the leading position 10 years from now. Our daily plan is to accelerate our pace and extend our testing menu in order to reach these goals.
A.S: Anything else you would like to share with our readers?
P.A: GenePOC’s revogene platform is the only fully integrated, multiplex sample-to-result system. In addition to a small footprint offering the flexibility to perform molecular testing where it is needed, the GenePOC PIE provides best-in-class sensitivity and specificity; flexibility with room temperature storage; an appropriate kit size that doesn’t require investment in inventory, nor waste too much in lot-to-lot external control; and economical packaging that reduces waste. GenePOC can make single analyte or multiplex tests based on what is appropriate for the disease state and reimbursement.
Courtesy of GenePOC
Patrice Allibert, PhD., CEO and President of GenePOC
With the contribution of Herbert Torfs, Vice President Business Development and Strategy and Mike Blitz, Vice President Marketing of GenePOC
Sébastien Clerc works as a Medical Technologies & Market Analyst at Yole Développement (Yole). As part of the Medical Technologies (MedTech) business unit, Sébastien authored a collection of market and technology reports dedicated to topics such as microfluidics, point-of-care, MEMS for healthcare applications and connected medical devices. In parallel, he is daily involved in custom projects such as strategic marketing, technology scouting and technology evaluation to help academic and industrial players in their innovation processes. Thanks to its technology & market expertise, Sébastien has spoken in more than 10 industry conferences worldwide over the last 2 years.
Sébastien Clerc is graduated from Grenoble Institute of Technology (Grenoble INP – Grenoble, France) with a Master degree in Biomedical Technologies. Then he completed his cursus with a Master degree in Innovation and Technology Management in the same institute.
As a Technology & Market Analyst in the Medical Technologies (MedTech) business unit at Yole Développement (Yole), Asma Siari is involved in the development of technology & market reports as well as the production of custom consulting projects.
After a Master’s degree in Biotechnologies, Diagnostic Therapeutics & Management, Asma served as Research Assistant at the Moores Cancer Center (San Diego, CA).
She is a coauthor in two scientific publications published in the Molecular Cancer Research Journal.
Asma Siari is graduated with an Advanced Master’s degree in International Strategy & Marketing BtoB from EM Lyon Business School (France).
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