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FCMB receives Frost & Sullivan's "New Product Innovation Award 2010"

Thursday, 01 July 2010 10:19

LONDON - 29 June, 2010 - Frost & Sullivan is pleased to announce that it has awarded its prestigious 2010 Scandinavia New Product Innovation Award to FCMB ApS (“FCMB”) for its breakthrough work in non-invasive prenatal testing. FCMB is developing a suite of non-invasive prenatal diagnostics based on isolating fetal cells from maternal blood samples. FCMB’s diagnostics have the potential to provide results that are as accurate as more invasive procedures, such as amniocentesis and chronic villus sampling (CVS), without the risk of miscarriage or other fetal damage.

The scientific community has known for many decades that fetal cells circulating in maternal blood could be utilized to diagnose genetic abnormalities. However, isolating these cells is difficult given their extreme scarcity. Taking a novel approach to this problem, FCMB has developed a proprietary technology that allows for the collection and preservation of fetal cells from maternal blood samples. These cells can be subsequently analyzed using standard molecular biology procedures to determine genetic abnormalities in a non-invasive fashion.

“We are quite excited about the about the opportunity ahead of us in prenatal testing,” says Dr. Andreas Eckelt, Chief Executive Officer of FCMB. “We believe that our technology has the potential to significantly improve the standard of care, while providing meaningful cost advantages to the healthcare system.”

Under current guidelines, parents of unborn children and the medical community face a dilemma when it comes to prenatal testing. Non-invasive diagnostic techniques, such as ultrasound or maternal serum sampling, can only provide risk stratification, as they lack specificity and can identify only predominant genetic aberrations. Invasive techniques, such as amniocentesis or CVS, provide conclusive results, but also carry a 1-2 per cent risk of miscarriage. Because of this risk, invasive testing is currently limited to approximately 5 per cent of pregnant women.

“Given the unmet need in the multi-billion dollar market for prenatal diagnostics, there is a race to commercialize new technologies,” says Frost & Sullivan Senior Research Analyst, Arun.A.K. “While FCMB’s technology has yet to be commercialized, we believe that it has the potential to offer substantial accuracy advantages over other non-invasive techniques, as well as significant safety advantages over more invasive procedures.”

FCMB intends to offer its diagnostic testing using a service-based model. FCMB believes that the accuracy and risk profile of its diagnostics, combined with competitive pricing and the relative simplicity of a blood draw, will result in rapid adoption by the medical community. FCMB’s first test is for Down’s syndrome (Trisomy 21), which occurs in approximately one in 800 births and is characterized by lifelong intellectual and developmental disabilities. FCMB also has plans to expand its product offering to other genetic abnormalities such as Edward’s syndrome (Trisomy 18), Patau syndrome (Trisomy 13) and Klinefelter syndrome.

Each year, Frost & Sullivan presents this award to a company that has developed an innovative element in a product by leveraging cutting-edge technologies. The award recognizes the value added features and benefits of the product and the increased return on investment it offers customers, which in turn increases customer acquisition and overall market penetration potential.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

About FCMB ApS

FCMB was founded in 2005 with the vision of developing the first non-invasive prenatal diagnostics technology platform based on the capture of fetal cells in maternal circulation. FCMB has raised venture funding from Inventure Capital and Oestjvsk Innovation. FCMB has 15 employees and is based in Vejle, Denmark.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, enables clients to accelerate growth and achieve best-in-class positions in growth, innovation and leadership. The company's Growth Partnership Service provides the CEO and the CEO's Growth Team with disciplined research and best-practice models to drive the generation, evaluation, and implementation of powerful growth strategies. Frost & Sullivan leverages over 45 years of experience in partnering with Global 1000 companies, emerging businesses and the investment community from 40 offices on six continents. To join our Growth Partnership, please visit http://www.awards.frost.com.

::External News Link::

Danske forskere bag gennembrud i fosterdiagnostik

Danske forskere kan finde kromosomfejl hos fostre ved hjælp af en blodprøve tidligt i graviditeten frem for ved en risikabel moderkageprøve. Dermed kan en række ufrivillige aborter undgås

25. May 2009 00:00

Inden for få år vil en blodprøve fra en kvinde tidligt i graviditeten være nok til at vise, om fostret har Downs syndrom eller andre kromosomsygdomme. Sådan lyder det fra det danske biotekfirma FCMB, der har forsket i fosterceller i årevis og nu har fået et stort gennembrud. - colourbox.

Af Line Vaaben

- Alting kan jo gå i fisk, men vi er tæt på 100 procents træfsikkerhed, og jeg føler mig meget, meget godt tilpas. Man har forsøgt det her i 40 år og fejlet og fejlet. Så det er et stort skridt for de tusindvis af kvinder, det vil komme til at hjælpe. Og helt personligt er det en videnskabelig triumf, hvis det lykkes i sidste ende, siger Steen Kølvraa, professor i klinisk genetik ved Syddansk Universitet og videnskabelig rådgiver for firmaet.

Dansk biotekselskab har isoleret fosterceller i gravides blod. Dermed vil kromosomfejl som Downs syndrom kunne afsløres uden risikable fostervandsprøver.

Af This e-mail address is being protected from spambots. You need JavaScript enabled to view it , søndag 24. maj 2009 kl. 10:00

Fostercellerne i blodprøven fra den gravide identificeres ved at tilsætte et antistof, der vha. fluorescens markerer fosterceller. Her er der én – de andre celler er den gravides egne celler i blodet. (Fotos: FCMB)

En enkelt blodprøve fra en gravid kvinde vil i fremtiden kunne afsløre, om hendes foster lider af Downs syndrom eller andre sygdomme. Det er håbet hos Vejle-virksomheden FCMB, der vil erstatte risikable fostervandsprøver og usikre blodanalyser.

Det er lykkedes forskerne hos den lille biotekvirksomhed at isolere celler fra fostret i den gravides blod samt udvikle en test, der på basis af disse celler hurtigt kan afsløre, om fostret har den kromosomfejl, der giver Downs syndrom.

»Enhver gravid kvinde har celler fra fostret i sin egen blodbane, men det er kun en til to celler i hver milliliter blod, så det har hidtil været meget svært at isolere disse celler. Som at finde en nål i tusind høstakke,« siger Andreas Eckelt, der er administrerende direktør for FCMB - en forkortelse, der står for Fetal Cell in Maternal Blood.

P1 Business 18. juni 2009 kl. 13:03 på P1

Hør udsendelsen (55:40)

Virksomheden FCMB i Vejle har udviklet en metode, der kan erstatte den risikable fostervandsprøve med en ufarlig blodprøve.

Men der mangler penge til at færdigudvikle metoden til produktion. Hidtil har danske investorer skudt 28 mill. kroner ind i virksomheden, men nu er danske kilder tørret ud, og FCMB må søge til udlandet for at overleve.

Regeringen må skride ind
Det er desværre billedet for mange af de nye virksomheder, siger Ulla Brockenhuus-Schack fra venturefonden Seed Capital.

Seed Capital har skudt penge i 60 virksomheder.

- Og 14 af de virksomheder vil dø henover sommeren, hvis ikke der kommer flere penge til at fortsætte udviklingen.

De næste to måneder er afgørende - det bliver en spændende sommerferie, oplyser Ulla Brockenhus Schack til P1 Business.

Hun mener, at det er absolut nødvændigt, at regeringen skyder ekstra penge ind i denne sektor. Ellers dør virksomhederne.

Ikke kun venturselskaberne er i krise
Men det er altså ikke bare venturselskaberne der er i krise, mener Colette Brix.

- Hver eneste dag kommer virksomheder til mit kontor med dårlige sørgelige budskaber. Alle er i samme båd. Og vi kan ikke forskelsbehandle brancherne, siger Colette Brix, som understreger at hun har store forventning til, at bankerne igen begynder at låne ud til erhvervslivet, når regeringens Bankpakke 2 når ud til bankerne.

Bankerne kan her låne 75 milliarder kroner i særlig risikovillig kapital.

Bankpakken er ikke nok
- Men bankpakken er slet ikke løsningen for denne type virksomheder, siger adm.dir. Christian Motzfeldt fra Vækstfonden.

- Den her type virksomheder skal have tålmodig risikovillig kapital. De kan ikke låne penge i banken, uddyber han.

Dansk Industri finder det dybt bekymrende at virksomhederne bliver ofrene for at finansmarkederne ikke fungerer.

Direktør i DI, Lars Goldschmidt mener, at staten bør spytte 1,5 milliarder kroner i Vækstfonden, som forvejen støtter den type virksomheder.

En af Danmarks største fagforeninger Dansk Metal støtter nu forslaget.

- Der er i høj grad behov for at samfundet gør noget. Ellers forsvinder disse virksomheder
til udlandet og vi mister beskæftigelsen. Det er netop denne type virksomheder, vi skal leve af i fremtiden, siger formand for Dansk Metal Thorkild E. Jensen.

Og scenariet kan meget vel være en realitet for virksomheden FCMB.

Hvis virksomheden får success er der mulighed for en omsætning på mellem 30 og 40 milliarder kroner.

- Det første vi bliver mødt af hos amerikanske investorer er hvornår kan i flytte til Atlanta, fortæller forretningsudvikler Otto Bjerg Hausgaard fra FCMB, som står for Foster Celler i Moders Blod.

Han ville klart foretrække danske investorer, men mest sansynligt er at virksomhedens fremtid ligger i USA.

2.sektion
I denne uge holdt Forsknings og innovationsstyrelsen en konference om hvordan virksomheder kan forberede sti til den anden side af krisen.

Ideerne skal skabes nu.

Hvordan de bliver realiseret, det inspirerede blandt andre erhvervsmanden Lars Kolind til.

External News Link

Risk-free Prenatal Testing Breakthrough

Danish Biotech Company, FCMB, has discovered a breakthrough in risk-free prenatal diagnostic.

(Press Release)

Vejle, Denmark (MMD Newswire) December 29, 2008 -- Danish Biotech Company, FCMB, has discovered a breakthrough in risk-free prenatal diagnostic. For the first time specific gene expression information from fetal cells isolated from maternal blood samples is available. FCMB has created a cDNA library originating from fetal cells revealing expression patterns different from maternal blood cells.

“This is a major step forward towards our goal to provide a tool for a reliable noninvasive prenatal diagnostic to all pregnant women. We are excited that our risk-free method for diagnostic testing will revolutionize prenatal care,” said Andreas Eckelt, CEO of FCMB, Fetal Cells in Maternal Blood. He continued, “Based on the obtained expression information it will be possible to specifically select such cells from a pregnant woman’s blood sample. Accessing fetal cells for subsequent genetic analysis without the need of invasive methods will lead to a paradigm shift in prenatal disease management.”

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