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Annual Report 2002 - Roche

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Unparalleled product pipeline<br />

Near Patient Testing 9<br />

All business areas expected to contribute<br />

major innovations in the next five years<br />

and its tests for hepatitis B and C and<br />

sexually transmitted diseases delivered<br />

especially robust growth.<br />

The gains in this business area reflect<br />

strong demand for products based<br />

on the highly sensitive polymerase<br />

chain reaction (PCR) technique. Using<br />

PCR technology, it is possible to copy<br />

specific segments of genetic material<br />

millions of times over, including even<br />

the tiniest fragments of bacterial or<br />

viral DNA. PCR-based tests thus afford<br />

a means of diagnosing a number of<br />

conditions rapidly and very reliably.<br />

Diabetes Care 22<br />

Molecular Diagnostics 34<br />

Applied Science 21<br />

Centralized Diagnostics 20<br />

Following successful launches in a<br />

number of markets, a new version of<br />

our highly sensitive Amplicor HIV-1<br />

test was cleared in the United States<br />

in mid-<strong>2002</strong> for use in monitoring<br />

patients’ responses to AIDS therapy.<br />

In December <strong>2002</strong> the FDA also<br />

granted regulatory clearance for our<br />

Cobas AmpliScreen System, further<br />

strengthening our position in the<br />

blood screening sector; FDA approval<br />

of <strong>Roche</strong>’s PCR-based hepatitis C and<br />

HIV tests designed for use with the<br />

system followed later the same month.<br />

<strong>Roche</strong> tests are already used to screen<br />

all donor blood in Japan, the Netherlands<br />

and the United Kingdom.<br />

A broad portfolio of human papillomavirus<br />

(HPV) patents acquired from<br />

the Institut Pasteur has given us a solid<br />

basis for developing and marketing<br />

products for the early detection of<br />

HPV infection. HPV is the leading<br />

cause of cervical cancer, a disease in<br />

which early diagnosis and treatment<br />

are critical for a positive prognosis.<br />

Late in 2003 we plan to market an<br />

HPV test that we expect will supplant<br />

conventional Pap smear testing in the<br />

mid term.<br />

Agreements like the one signed with<br />

the Institut Pasteur and another establishing<br />

a strategic alliance with Qiagen<br />

to develop and commercialise an integrated<br />

nucleic acid diagnostics system<br />

are carefully targeted at reinforcing<br />

our leadership in molecular diagnostics.<br />

In January 2003 <strong>Roche</strong> Diagnostics<br />

and Affymetrix signed an agreement<br />

that grants <strong>Roche</strong> non-exclusive rights<br />

to Affymetrix’s array and instrument<br />

technologies for up to 18 years. One<br />

of the benefits of having access to<br />

GeneChip technology is that it will<br />

enable us to develop specific diagnostic<br />

laboratory tests for a wide range<br />

of diseases. We are confident that the<br />

synergies between Affymetrix’s<br />

GeneChip platform and <strong>Roche</strong>’s PCR<br />

technology will establish new standards<br />

in genetic testing, making it possible to<br />

tailor therapies to individual patients’<br />

profiles, and will further enhance<br />

<strong>Roche</strong> Diagnostics’ attractiveness as<br />

a partner for companies working on<br />

the development of markers to guide<br />

individualised therapies.<br />

40 Diagnostics

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