OUR VENTURE AT A GLANCE

» WHY … is it rea­son­able to invest in can­cer diagnostics ?

Treat­ment alone will not win the war on can­cer: pre­ven­tion and early detec­tion are cru­cial, as clearly stated in the WHO World Can­cer Report 2014.

Despite legions of researchers try­ing to find appro­pri­ate diag­nos­tic and cura­tive mea­sures, over­all can­cer mor­tal­ity could not be reduced for decades. Cur­rently, there is an urgent need for reli­able non-​invasive diag­nos­tic tools.

» WHATis Onco­Lab Diagnostics?

Onco­Lab­Di­ag­nos­tics GmbH is a can­cer diag­nos­tics devel­op­ing com­pany. We have devel­oped cer­tain inno­v­a­tive tech­nolo­gies to diag­nose can­cer much ear­lier, and to detect and analyse traces of can­cer in the patient’s body, all through a sim­ple blood draw. This allows mon­i­tor­ing a patient’s response to treat­ment and select­ing the most appro­pri­ate therapy.

» WHATare Onco­Lab Diag­nos­tics’ goals?

Despite enor­mous efforts around the world, for decades over­all can­cer mor­tal­ity could not be reduced. Thus, there is an urgent need for reli­able non-​invasive tools for ear­lier detec­tion of can­cer. Onco­Lab Diag­nos­tics aims to become a lead­ing devel­oper and provider of diag­nos­tic can­cer tests. To achieve our goals we engage in prod­uct devel­op­ment in close coop­er­a­tion with renowned world­wide acad­e­mi­aand indus­try part­ners. Onco­Lab Diag­nos­tics con­tributes sub­stan­tially to enhanc­ing sur­vival time and qual­ity of life of can­cer patients and reduc­ing can­cer mor­tal­ity by devel­op­ing, man­u­fac­tur­ing and mar­ket­ing highly inno­v­a­tive and utmost pre­cise can­cer tests.

» WHATare our strengths and assets?

Excel­lence –Pro­fes­sor R. Zeillinger has more than 30-​years’ expe­ri­ence in aca­d­e­mic and indus­trial research in the field of mol­e­c­u­lar oncol­ogy as well as in the man­age­ment of diag­nos­tic enter­prises. In addi­tion, he has suc­cess­fully coor­di­nated inter­na­tional research projects and is a dis­tin­guished author of a large num­ber of sci­en­tific publications.

Achieve­ments – Early detec­tion tests have been devel­oped for ovar­ian, breast and pan­cre­atic can­cer, dis­play­ing unprece­dented sen­si­tiv­ity and speci­ficity. Ther­apy mon­i­tor­ing tests have been devel­oped for var­i­ous types of can­cer – in par­tic­u­lar for breast can­cer and gynae­co­log­i­cal cancers.

Patents – Intel­lec­tual prop­erty rights forall diag­nos­tic tests are secured.

Access to Patients & Bio­ma­te­ri­als Excel­lent access to patients, bio­ma­te­ri­als, and clin­i­cal infor­ma­tion through the Med­ical Uni­ver­sity of Vienna and other uni­ver­sity & med­ical cen­ters world­wide is a unique asset – an advan­tage other com­pa­nies usu­ally don’t have.

Net­work – Inter­na­tional net­work of basic & trans­la­tional sci­en­tists, clin­i­cians, can­cer cen­ters and universities.

A step ahead –Up to date there is no diag­nos­tic test for can­cer on the mar­ket which is based on RNA expres­sion bio­mark­ers in immune cells. Like­wise, none of the exist­ing meth­ods shows suf­fi­cient sen­si­tiv­ity and speci­ficity for reli­able test results — much less do they have a poten­tial for screen­ing of high-​risk per­sons or even population-​wide screen­ing. Our proven con­cept with excep­tional sen­si­tiv­ity and speci­ficity posi­tions us a step ahead of our competitors.

» WHATis our busi­ness strategy?

Based on recent research results from the Med­ical Uni­ver­sity of Vienna/​Austria and the Uni­ver­sity of Athens/​Greece, we have devel­oped can­cer tests for many dif­fer­ent types of can­cer (breast, ovar­ian, endome­trial, cer­vi­cal, lung and pan­cre­atic can­cer) with out­stand­ing speci­ficity and sen­si­tiv­ity. The can­cer test prod­uct lines will be mar­keted under the brand Dx4U®.

Test (kit) pro­duc­tion facil­i­ties and R&D will be located in Vienna. Test kits will be mar­keted world­wide and sold through an already exist­ing net­work of dis­tri­b­u­tion part­ners. A subsidiary will be etablished in the United Stated.  Dx4U® USA will be a clin­i­cal diag­nos­tic ser­vice lab­o­ra­tory, gov­erned by rel­e­vant United States fed­eral reg­u­la­tory stan­dards (CLIA). This will accel­er­ate reg­u­la­tory approval for the sale of test kits in the US and enable early revenue.

» WHATis Onco­Lab Diag­nos­tics’ mar­ket potential?

The mar­ket poten­tial for diag­nos­tic can­cer tests is excep­tion­ally high. The annual total mar­ket size is cal­cu­lated at USD 11 B for the U.S. and USD 2.7 B for the EU-​27. A major dri­ver of the mar­ket is the demo­graphic age­ing since can­cer risk increases for indi­vid­u­als above the age of 65.

» WHEREdo we stand?

Proof of Con­cept was suc­cess­fully car­ried out. All rel­e­vant IP rights are secured. Early Detec­tion Tests were designed for ovar­ian, breast and pan­cre­atic can­cer. Prognosis, Prediction and Monitoring Tests are being devel­oped for var­i­ous types of can­cer – in par­tic­u­lar for breast can­cer and gynae­co­log­i­cal cancers. The proprietory Speiser Catheter is offered in Europe as a CE-marked product. In the Unites States the FDA has classified the catheter as a non-significant risk device and allowed using it in clinical studies.

» WHAT are the next steps?

Setting-​up of facil­i­ties in Aus­tria and the USA. Tech­ni­cal and clin­i­cal val­i­da­tion stud­ies in order to obtain the nec­es­sary reg­u­la­tory approvals (CE-​IVD, CLIA).

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OncoLab Diagnostics GmbH
Hebbelplatz 5
1100 Vienna
Austria

© OncoLab Diagnostics GmbH, 2017