A Diagnostics & Imaging Week

Lab21 (Cambridge, UK) said it has entered into a partnership with deCODE genetics (Reykjavik, Iceland) to offer deCODE's tests for predisposition to a growing number of common diseases.

The license allows Lab21 to offer its clients in the UK and Ireland access to new tests for Type 2 diabetes, myocardial infarction, atrial fibrillation, prostate cancer and glaucoma.

This new agreement means Lab21 now has licenses with three major genetic test providers — deCODE, Myriad Genetics and PGxHealth, and is the only service provider in Europe to offer such an extensive range.

In addition, the license will allow Lab21 to offer a pipeline of new tests as they are developed by deCODE, including one for increased risk of oestrogen-positive breast cancer. All deCODE tests have been validated in thousands of patients and controls from multiple populations; have full regulatory approval; and will be handled through Lab21's clinical service laboratory in Cambridge.

Lab21's line of genetic tests now includes tests for breast, ovarian, skin and colorectal cancer, a comprehensive portfolio of tests for cardiovascular disease and now, with deCODE's tests for Type 2 diabetes, prostate cancer and exfoliating glaucoma, the first ones in new disease areas.

Dr. Berwyn Clarke, chief science and development officer at Lab21, said, "Genetic testing is becoming an increasingly important part of medicine. In many patients, awareness of clinical predisposition can provide critical early warnings of the possible development of disease and vital pre-emptive and precautionary measures such as dietary factors, detailed screening or pharmaceutical intervention can be implemented. This is critical as we work to shift the focus of healthcare from intervention to prevention."

CEO Graham Mullis added, "This deal ... ensures [that] we are able to provide our customers with the widest range of high-quality genetic tests in Europe."

Cervical cancer guidelines issued by DGGG

New cervical cancer prevention guidelines issued by the German Association for Gynecology and Obstetrics (DGGG) recommend testing women 30 and over for (human papillomavirus (HPF), the primary cause of cervical cancer. The guidelines recommend that HPV testing be performed along with a Pap smear for women 30 and older.

The digene HPV Test, developed by Qiagen (Venlo, the Netherlands), is currently the only HPV test approved by regulatory authorities in both Europe and the U.S., the company said.

"Our recommendations recognize the large number of scientific studies that demonstrate greater accuracy in identifying women at risk of having or developing cervical cancer, when a Pap is combined with the HPV test, rather than relying on a Pap smear alone," said Professor Klaus Friese, lead author of the new guidelines and professor of gynecology at the Ludwig-Maximilians-University (Munich). "By using both tests for women 30 and over, when cervical cancer is most common, we hope to greatly reduce the number of women suffering and dying from this disease."

The DGGG guidelines conclude that the sensitivity of the Hybrid Capture II (HC2) technology used by the digene HPV Test is comparable to PCR, the standard technology used in molecular testing. However, according to the guidelines, the specificity (association with actual disease) of HC2 is greater than that for PCR.

Every year, cervical cancer affects nearly 500,000 women worldwide and, after breast cancer, is the second most common malignancy in women. In Germany, 6,200 women are diagnosed with the disease and 1,800 die from it each year.

In most cases, the infection is cleared by the immune system or is suppressed without causing problems. However, in others, the infection persists, leading to abnormal cell changes and disease.

In Germany, the digene HPV Test is reimbursed by most private health insurers for routine screening. Many experts hope that public health insurance will cover HPV testing in the future for primary screening in conjunction with a Pap.

One pilot screening program already initiated is a partnership between public health insurer Deutsche BKK, the Wolfsburg clinical centre and gynecologists in private practice in the city. In the program, Deutsche BKK covers the cost of the digene HPV Test as screening for participants 30 years and older, in conjunction with a Pap.

No Comments