Breast Cancer: Worth its Price at DNAldi

26. April 2016

An American provider is shaking up the market with its genetic tests. For the unbeatable price of 249 US dollars it is able to offer its patients a search for 19 recognised cancer mutations, advice inclusive. A critical look behind the scenes.

Color Genomics is providing plenty of reasons in the USA for headlines. The startup enterprise from Burlingame, California, offers a saliva test for women which is then used in a search for 19 cancer genes. These include ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, EPCAM, MLH1, MSH2, MSH6, NBN, PALB2, PMS2, PTEN, RAD51C, RAD51D, STK11, TP53. The aim is to determine the potential risk of having a mammary or ovarian carcinoma. Unlike the competitors, the test is issued exclusively to physicians. Health professionals receive for the price of 249 dollars a kit for patients, so as to take a probe and have it examined in Color Genomics’ laboratory. Results are delivered in a commentary format directly understandable by lay people.

Knowledge for all

The low price has even astounded our American colleagues. As the breast cancer charity organisation reported to DocCheck, tests in the USA hit the cheque book to the tune of 300 to 5.000 dollars, according to the breadth of the testing – in other words, the number of genes. The respective costs are taken on by insurance companies in only some instances. Blue Cross Blue Shield of North Carolina for instance sets the precondition that cancer-based illness and genetic risks are present in close relatives, which makes screening virtually impossible. In Germany 3000 euro is the usual fee – legal entitlement to coverage of payment via health insurance does not exist. The problematic issue here: “Only 15 percent of carriers are aware of the risk they are carrying and have the possibility, together with their doctor, of working out a solution”, Othman Laraki, founder of Color, explains. Even patients without adequate coverage are able to afford the new tests.

Thrifty sequencing

Othman Larakis’ concept is based on several factors: next generation sequencing has revolutionised the market place. It delivers results in the shortest time frame, and prices sink from year to year. Color Genetics is not satisfied to just leave it at that, but rather goes further by seeking to make “big data” efficient to manage.

“Our focus rests on making use of larger, more performance-capable software systems designed for medical accuracy”, Kelly Tangney of Color Genetics tells DocCheck. Every part of every step is analysed, in order to find out which cost are able to be reduced – for instance by further automation – she says. Ultimately a platform emerges for evaluating bits and bytes in the most efficient manner. Tangney: “The price has sunken by a factor of ten – yet alongside we have higher quality”.

In the hand of the health professionals

The expert uses accreditations in accordance with CAP (College of American Pathologists) and/or CLIA (Clinical Lab Improvement Amendment CLIA) and internal standards. Other approval procedures are not required: “Laboratory tests, just like similar medical products for in-vitro diagnostics, do not fall at present under the auspices of the FDA. This group includes Color and similar providers of microbiology-based diagnostic tests, Kelly Tangney explains. The market is nevertheless not left fully unregulated. Authorities place great weight on the providers to not offer patients tests by the most direct pathways, something which pulled the brakes on “23 and Me” as it was flying at top speed. US media now report that the FDA has already issued warnings to a further three firms for offering direct-to-consumer tests as part of their offers: DNA4Life, DNA-CardioCheck and Interleukin Genetics. Color Genetics due to its business model being one run through physicians does therefore not lose out here, and is now looking to take on the European market.

“Serious business”

“Following studies of information on the web, this seems to be quite the real deal”, says Dr. Ralf Berg, specialist physician in general medicine and anaesthesiology at Ühlingen-Birkendorf, Germany. Negative results lead to no further need for advisor sessions; they could however ease the angst experienced by many women. In the instance of positive results, everything is crucially dependent on the qualifications of the physicians who are advising them. “This assessment demands specialised knowledge”, states Ralf Berg, giving food for thought. “When it is the case that the relevant MDs have the requisite qualifications, by my judgement qualitative advise can be assumed, and when if as stated this really is a cost-free inclusive part of the process, it [can also be said to be] a thrifty offer”. He finds fault nevertheless with the expert discussions from Color Genetics only being conducted in English – only “native speakers” would understand everything.

His summary: “The offer is very good value, given that with positive finding – as is purported – a comprehensive follow-up briefing takes place conducted by medical staff possessing demonstrable qualifications and is understood by the patient”. It remains to be seen whether Color Genetics puts other firms under pressure with its business model, so that they get their own innovations running and re-examine their costing programs.

9 rating(s) (3.11 ø)
Gynaecology, Medicine

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