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  1. Flatlander 17 februari 2020 23:26

    JPTM > Volume 53(6); 2019 > Article

    Original Article
    Journal of Pathology and Translational Medicine 2019; 53(6): 386-392.

    Published online: October 11, 2019


    Clinical Utility of a Fully Automated Microsatellite Instability Test with Minimal Hands-on Time
    Miseon Lee1, Sung-Min Chun1,2, Chang Ohk Sung1,2, Sun Y. Kim3, Tae W. Kim3, Se Jin Jang1,2, Jihun Kim1,2

    The review of Idylla MSI test by several South Korean authors was quite favorable. See discussion below.

    The positive take away points were. Idylla is:
    1) Fast;
    2) Accurate;
    3) Sensitive;
    4) Requires very little technician sample prep time;
    5) Provides easily interpreted results; and
    6) Requires little room/facility preparation (clean rooms etc.)

    The only negatives were the following:

    1) Idylla is a destructive test procedure. Sample cannot be pulled out and retested by another method;
    2) The throughput is relatively low. Assuming an 8 unit device about 32 analyses can be completed per day. This may be a problem for very high volume testing centers.
    3) The consumable cost was higher for Idylla than Standard PCR.

    I may differ on negative point no. 3 since they do not state how costs were calculated. If reagents, clean space and technician time/salary plus the salary of a qualified genetic scientist to interpret results are included, I would think that Idylla is cheaper. Probably not a problem considering the other advantages listed. I included some of the discussion below:

    In this study, the Idylla MSI assay demonstrated excellent diagnostic performance when we tested the fully automated kit with 115 CRC samples with rigorously confirmed MSI results. In addition, the test successfully detected MSI-H status in samples with very low tumor purity (down to 10%), although the tumor purity estimates were inevitably crude. Our findings suggest that the Idylla MSI assay could be used in the clinic to determine MSI status, at least for CRC samples, and that macro-dissection may not be required in most CRC cases. Since the Idylla MSI assay does not require DNA extraction and reagent loading steps, the hands-on time could be greatly reduced.
    The identification of MMR deficiency is important not only for the identification of the risk for Lynch syndrome but also for the appropriate treatment approach and prognosis for sporadic tumors [10]. MMR deficiency can be diagnosed by PCR fragment analysis, NGS, and MMR protein IHC test [8]. MMR IHC staining is used as a first-line screening method and is used as a good surrogate marker for MSI, but heterogeneity has previously been well described [10,11]. PCR fragment analysis has been widely used as a standard method and NGS-based MSI detection is now increasing, but both methods are time-consuming and labor-intensive. The Idylla MSI assay offers a fully automated workflow from direct FFPE tissue input to a simple final report (Supplementary Fig. S2) and achieved a short turnaround time (about 150 minutes) and minimal hands-on time (less than 2 minutes). When we simulated actual hands-on time in maximum throughput environment (8 samples/run for the Idylla MSI assay, 32 samples/run for the standard MSI PCR assay, and 24 samples/run for the NGS in Illumina NextSeq platform), the hands-on time per sample was 30 seconds for the Idylla MSI assay, 5 minutes for the standard MSI PCR test, and 120 minutes for the NGS. Thus, the Idylla MSI assay may significantly save time and manpower. The downside of the Idylla MSI assay, however, is that only one sample can be processed in each instrument unit at a time. Thus, to increase sample throughput, multiple instruments are required (up to 8 instruments per one console, according to the manufacturer). Requirements for multiple instruments and usage of one sophisticated cartridge per one sample may make this test to be more expensive than the standard PCR assay......

    ...In summary, the Idylla MSI assay is fast, accurate, and reliable, and thus might be clinically applicable. The fully automated workflow may offer a significant reduction in time and labor although the cost for consumables or cartridge is higher than that of the standard MSI PCR test. In addition, colonoscopic biopsy specimens in the case of initially metastatic disease may be easily processed because this test does not require a matched normal tissue sample.

    I think this is important since this assay was just released in the EU last year and BCART has discussed it as a growth driver. Also, tech articles such as this can help with traction in the large Asian markets.

  2. Flatlander 18 februari 2020 04:16
    The January 28 tweet indicates the bridging study has been completed which demonstrates that the Idylla IVD results correlate well with the lab approved Septicyte test. This is certainly a critical step for FDA approval of the IVD.

    I don't see anything that would make me doubt the Oct 3, 2019 statement that Septicyte rapid on Idylla would receive EU Marking in the 1st quarter and FDA approval by Midyear.


  3. MisterBlues 18 februari 2020 18:07

    makyjo schreef op 14 februari 2020 14:56:

    [...]Volgens de website van Euronext iw Novacyt helaas ook in oncologische diagnostica gespecialiseerd.Ze hebben een accuraat en snelwerkend,stabiel diagnosticum species op de Chinese stamvaruant van het Cornavirus ontwikkelt en op de markt gebracht.Ze krijgen massa's orders binnen.Vandaar dat hun koers laatste dagen en dus ook vandaag aan het 'moonshinen' is. Ben deze morgen alsnog (maar helaas te laat maar toch...) nog voor 6280 stuks ingestapt aan 0,985 € en momenteel staan ze genoteerd rond 1,20€.Jammer dat Biocartis de boot 2 m. geleden afhield bij de ontwikkeling van diagnosticum,want toen was de vraag wie er de eerste zou zijn en het antwoord is vandaag gekend,nb. een veel kleinere speler op de markt die hen zeker geen windeieren zal leggen!!En vermoedelijk is het ritje nog niet ten einde want men spreekt luidop van een notering op Nasdaq...

    “Volgens de website van Euronext iw Novacyt helaas ook in oncologische diagnostica gespecialiseerd.”

    Hoe bedoel je: helaas ook? Novacyt kan niet in de schaduw staan van Biocartis als het gaat om haar oncologische testen: niet qua accuratesse en validiteit noch qua gebruiksgemak noch qua hoeveelheid domeinen.

    Het klopt dat Novacyt door de waanzin van de corona epidemie een ongelooflijke koersexplosie heeft doorgemaakt dankzij de ogenschijnlijke beloftes van haar kortdurende ‘corona’ test (2 uur) met RUO status. We weten niet hoe het gaat aflopen met Novacyt maar er zijn wel veel spelers en er is sprake van een ramp, en dus zijn er altijd meer opties en spelers nodig.

    Voor je beeldvorming voeg ik een lijst toe van spelers in de ‘corona-markt.’ Zie volgende kader:

  4. MisterBlues 18 februari 2020 18:07
    Below are the players who have disclosed, to date, they are developing molecular diagnostic tests and reagents for 2019-nCoV:

    Amoy Diagnostics (Xiamen, China) — developed a PCR-based test kit and has entered the NMPA emergency approval channel.

    Altona Diagnostics (Hamburg, Germany) — developing a real-time RT-PCR based assay for the qualitative detection of 2019-nCoV RNA in respiratory samples.

    Biomeme (Philadelphia) — tests called 2019-nCoV Go-Strips that run on Biomeme's mobile handheld qPCR devices are available on the firm's website. The test contains coronavirus RNA target multiplexed with Biomeme's RNA extraction and RT-PCR control (MS2), with each order containing 10 individually packaged Go-Strips that are shelf-stable for up to two years.

    Bioneer (Daejeon, Korea) — submitted a diagnostic test kit for emergency use assessment and listing (EUAL) to the Korea Centers for Disease Control and Prevention (KCDC).

    CerTest (Zaragoza, Spain) — developing a test kit called VIASURE 2019-nCoV Real Time PCR Kit, based on its existing qPCR tests for other coronaviruses.

    Center for Convergent Research of Emerging Virus Infection (CEVI) at the Korea Research Institute of Chemical Technology and Wells Bio (Seoul, Korea) — pursuing joint development and commercialization of molecular and immunological diagnostics to detect a 2019-nCoV gene and a viral antigen.

    Columbia University (New York City) — the lab of Ian Lipkin is reportedly developing a test to detect and differentiate 2019-nCov from influenza.
    Coyote Bioscience (Beijing) — has reportedly submitted its one-hour, sample-to-answer 2019-nCoV Prep Free QPCR Assay to NMPA for emergency authorization. It runs on the firm's CFDA-approved Mini8 Portable Molecular Diagnostic QPCR Station. The test is reportedly being used as an RUO in China in more than 30 hospitals, 16 local CDC offices, and eight airports, and the firm has donated 500 instruments to Hubei province.

    GeneFirst (Oxford, UK) — developing two test kits; a three-hour PCR-based test for 2019-nCoV, and a multiplex PCR assay for 2019-nCoV as well as 17 other common viruses and bacteria.

    Genekam Biotechnology (Duisburg, Germany) — developed singleplex and multiplex test kits to detect 2019-nCoV as well as to distinguish it from other infections, such as influenza, MERS, and viruses commonly found in bats.

    Genomica (Madrid) — developing a 2019-nCoV diagnostic kit to simultaneously analyze 96 patient samples in less than five hours, to be available in five to seven weeks, using the firm's low-density microarray-based platform. Genomica has also had a subsidiary in Wuhan, China, named HuaSin Science, since January 2018.

    GenScript (Piscataway, New Jersey) — has launched a one-step 2019-nCoV quantitative reverse-transcription polymerase chain reaction (qRT-PCR) based on the World Health Organization's protocol. The firm is also marketing plasmids encoding the surface glycoprotein and nucleocapsid phosphoprotein of 2019-nCoV that can be used as positive control for the detection of 2019-nCoV by RT-PCR.

    IDbyDNA (Salt Lake City, Utah) — the firm's Explify Respiratory test uses next-generation sequencing-based metagenomics to detect 2019-nCoV as well as over 900 other viral, bacterial, fungal, and parasitic pathogens. It is a validated LDT currently offered by IDbyDNA's Salt Lake City lab for respiratory pathogens, including human coronaviruses, and its 2019-nCoV detection has been computationally validated using in silico generated samples.

    Kogene Biotech (Seoul, Korea) — submitted a diagnostic test kit to the KCDC for EUAL.

    LabGenomics (Seoul, Korea) — developing a kit and anticipates commercialization in the next two months.

    Lexagene (Beverly, Massachusetts) — developing a test for its one-hour, open-access LX Analyzer system.

    Novacyt (Paris and Camberley, UK) — the firm's molecular diagnostics division, Primerdesign, has launched a two-hour molecular test, available as an RUO test, designed to run on multiple molecular testing platforms, including Primerdesign's genesig q16 and q32 instruments.

    PCL (Seoul, Korea) — in the process of commercializing its multiplex diagnostic kit.

    Roche Diagnostics (Basel, Switzerland) — the firm has partnered with Tib-Molbiol to launch three research-use-only assays for the LightCycler 480 high-throughput real-time PCR instrument, as previously reported.

    Thermo Fisher Scientific (Waltham, Massachusetts) — has developed a real-time PCR kit for the detection of RNA from 2019-nCoV, using Applied
    Biosystems TaqMan Assay technology, which is now available to order. The firm is also developing a multiplexing test that offers a faster time-to-result to further expand laboratory capacity, which will be available within the next few weeks, as well as a syndromic panel it expects to be available in late February.

    TCM Biosciences (Seoul, Korea) — developing a test called TCM-Q Corona III.

    University of Hong Kong (Hong Kong) — researchers have developed two single-step quantitative real-time reverse-transcription PCR assays to detect two different regions of the viral genome, as described in a recent Clinical Chemistry study.

    Firm's with nCoV-related reagents

    Integrated DNA Technologies (Coralville, Iowa) — the firm is now accepting pre-orders for qPCR primers and probes designed to detect 2019-nCoV from the global health and research communities, with shipment to begin next week.

    LGC (Milford, Massachusetts) — the firm's SeraCare Life Sciences subsidiary has developed molecular reference materials for coronavirus utilizing their proprietary AccuPlex recombinant technology. The AccuPlex reference materials mimic wild-type pathogenic viruses, but are safe, non-infectious, and replication-deficient. LGC's Biosearch Technologies subsidiary is also expediting availability of its as Black Hole and Blackberry Quenchers (BHQ and BBQ) and other dyes and components used in diagnostic kits, as these are explicitly mentioned in the publication describing the primer and probe sequences recommended for 2019-nCoV diagnosis.

    Longhorn Vaccines and Diagnostics (Bethesda, Maryland) — the firm has announced its PrimeStore MTM collection medium is the first and only device that is validated for coronavirus and that the FDA created a new category for it: FDA Cleared: New Class II Predicate Device Oral and Nasopharyngeal swab screening. Samples collected into PrimeStore MTM may provide early detection of coronavirus carriers and spreaders prior to symptoms such as fever, and they can be tested in any molecular lab, not just containment facilities.

    Meridian Bioscience (Cincinnati, Ohio) — the firm's freeze-dried Lyo-Ready 1-Step RT q-PCR mix is reportedly being used in the coronavirus outbreak in China.

    Thermo Fisher Scientific (Waltham, Massachusetts) — the firm supplies various master mixes and polymerases for diagnostic testing that have been cited in several publicly available 2019-nCoV real-time PCR protocols.
  5. Flatlander 18 februari 2020 23:09
    Here is the last Idylla discussion from GHDX before things went silent after the EXAS merger.

    Genomic Health's Second Quarter Was So Great It Got the Company Acquired
    Exact Sciences takes out the cancer-test maker for $2.8 billion.
    Brian Orelli
    Aug 7, 2019 at 10:05AM


    What management had to say
    CEO Kimberly Popovits talked about the benefits of the acquisition: "This combination provides significant and immediate cash value for our shareholders and with the stock component creates the opportunity to participate in the upside potential of the combined company. We have great respect for the Exact Sciences team, and we believe we have found a tremendous partner to advance our mission."

    Popovits also highlighted the company's partnership with Biocartis to run Genomic Health's tests on Biocartis' Idylla systems:

    It certainly opens up the global markets for us. With the announcement of the reimbursement decision in Germany, it's just a really incredible starting point to bring that platform to major markets in Western Europe, and we'll see how we can expand it from there. But also it could have implications for the future pipeline of the combination here.

  6. MisterBlues 19 februari 2020 09:38
    Thank you for all your messages about BCART. I always read them diagonally. As mentioned earlier, I only want to be active on this forum if there are any press releases from BCART. In other words: until 5 March.

    I make an exception for people who use gross untruths on this forum or for occasions where there has been an enormous influence on the course.

    Kind regards,

    (One for the money, one for the show, one for the girls cause I like them soooooooo !!!!!!!!!!)
  7. Squeeze 19 februari 2020 15:23

    Op 6 uur tijd nog geen 40.000 aandelen verhandeld. De koers wordt bepaalt door de shorters die de koers liefst zien dalen. Maar bijna iedereen houdt zijn aandelen stevig vast want bij positief nieuws, kunnen de shorters de stijging niet meer tegenhouden, nog 2 weken voor de cijfers.

  8. Flatlander 20 februari 2020 04:04
    From time to time we have discussed the FDA approval process for CDx IVD assays.

    Given that the MSI assay is largely operator independent (i.e., does not require extensive training at each testing facility) and has already completed extensive validation analyses, I believe that the Idylla MSI assay is likely to have been eligible to have received some process exemptions (IDE). Furthermore, assuming that the BMS- Covance agreements correspond to close to the start of the FDA CDx process (i.e., almost a year ago), I believe it is reasonable to expect this approval this year. Hopefully, completing this process paves the way for subsequent assays.


  9. lextamindose 20 februari 2020 11:26

    Laup 4 schreef op 19 februari 2020 15:23:

    Op 6 uur tijd nog geen 40.000 aandelen verhandeld. De koers wordt bepaalt door de shorters die de koers liefst zien dalen. Maar bijna iedereen houdt zijn aandelen stevig vast want bij positief nieuws, kunnen de shorters de stijging niet meer tegenhouden, nog 2 weken voor de cijfers.

    Dag Laup 4 is dit onderbouwd of is er voorlopig weinig belangstelling? Denk wel dat er iets op til is maar wat zullen we moeten afwachten.

    Ik heb alvast meer ingekocht, denk niet dat we hier nog lang zullen blijven hangen.
  10. Squeeze 20 februari 2020 12:34

    lextamindose schreef op 20 februari 2020 11:26:

    [...] Dag Laup 4 is dit onderbouwd of is er voorlopig weinig belangstelling? Denk wel dat er iets op til is maar wat zullen we moeten afwachten.

    Ik heb alvast meer ingekocht, denk niet dat we hier nog lang zullen blijven hangen.

    Hallo lextamindose, een shorter kan een stijging voorkomen door desnoods eigen aandelen te verkopen en lager terug te kopen. Hun shortpositie is ongeveer 4% maar dat zal niet volstaan om bij goede resultaten een stijging tegen te houden. We hoeven zelfs niet te wachten op 5 maart, in deze laatste 2 weken voor de cijfers kunnen we al flink hoger gaan, succes!
  11. Squeeze 20 februari 2020 20:27

    Na het sluiten van de beurs, is een groot deel van de verkopers verdwenen. De "laat" staat weer op 5,96 en de andere zijn weg, tot morgen en dan staat er weer een blok. Dat betekent dat de shorters de zaak controleren volgens mijn bescheiden mening. Het enige minpunt dat ik heb is het coronavirus, dat is voor geen enkel bedrijf een geschenk, maar ook dat zal een oplossing vinden.

  12. joe123 21 februari 2020 12:00
    Ben met belangstelling het koersverloop van Galapagos aan het volgen.Zo zie je maar wat die shorters kunnen veroorzaken.Ze doen het wel in hun broek daar.Hopelijk goede resultaten en outlook voor Biocartis op 5/3. Kan dan ook veel teweeg brengen dat al die shorters hun kar moeten keren.
  13. Flatlander 21 februari 2020 19:39
    A few months ago I raised a lot of questions about the convertible. I found this interview useful in answering my questions. I know it is 8 months old, but it still provides useful information. It also helps to frame the big picture while the S.P. lumbers along at a 5 handle (i.e., the approvals of CDx registrations will enable our big partners to co-market Idylla products).
  14. Flatlander 22 februari 2020 03:44
    This Journal article appears to have provided a lot of the impetus for GHDX to seek out a quicker IVD solution for delivering OncoTypeDx breast cancer results. I predict a few years from now there will be a blockbuster study that demonstrates that Idylla OncotypeDx saves the healthcare system millions in unnecessary chemo and that it expedites appropriate treatment from 40-60 days to less than a week resulting in improved overall survival outcomes.

  15. Falcon16 22 februari 2020 15:26

    CGCDLR schreef op 22 februari 2020 14:48:

    Full year 2019 results/2020 outlook 5 march 2020!Nog 8 beursdagen en we weten meer.

    Ik duim alvast...met hoop op goed nieuws natuurlijk! Ook wel benieuwd wie de nieuwe CFO zal worden in april,normaliter zou dit binnenkort ook gecommuniceerd moeten worden toch?
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