By Kirell Lakhman

Revenue from genetic tests, including those performed in CLIA labs, is expected to jump 26 percent over the next four years to $4 billion from $1.5 billion, according to a recent market analysis.

Called “Global Genetic Testing Market Analysis,” the report, which includes "several hundred" genetic assays," notes that genetic testing is "witnessing a strong growth pattern" and that it currently accounts for 15 percent of the entire molecular-diagnostics market — a behemoth of a sector that is poised or some significant growth of its own.

Covering "almost all aspects of the global genetic testing market," the analysis, downloadable for a fee here, attributed its 26-percent projection to a "significant increase in the number of available tests."

Authored by RNCOS Industry Research Solutions, the report is another piece of welcome news for clinical labs pummeled by a weak economy that has caused many patients to skip doctor visits.

In fact, it comes two months after I wrote that reinvigorated demand from physicians and hospitals for clinical testing will help the lab community recover some of that lost volume.

It also comes one business day after labs that perform — and especially develop — genetic tests were given reason to rejoice when a federal appeals court gave back to Myriad Genetics the right to patent two genes linked to its BRCA1/2 test.

But first back to RNCOS's analysis. The report said "factors contributing to this growth include increasing demand of newborn screening, high incidences of Alzheimer disease, breast cancer, colorectal cancer, diabetes, etc., and research innovations."

It also analyzes "the state of genetic testing market and developments" worldwide; the availability of gene tests for "key diseases;" and "recent developments [in] product launches and strategic acquisitions."

However, one potential flaw in the report is that it includes DTC genetic tests, which to me is a constituent that likely added too many known-unknowns to the report's arithmetic.

The adolescent segment is going through some severe regulatory changes that remain unclear even after more than two years' worth of threats, negotiations, and compromises between FDA and industry.

Sure, the broader molecular-diagnostics industry is itself steeping in a volatile regulatory stew of proposed controversial CLIA-testing changes and 510(k) procedural alterations — at least one recent proposal for the latter being downright draconian.

But DTC genetic testing is a different animal altogether. There are no existing regulations with which to tinker; the agency would have to create an entirely new trestle or include DTC genetic tests into an existing one.

To me, the report would have been much better and accurate had it focused exclusively on MD-ordered genetic tests performed in CLIA labs. And, as always, I remind readers to consider all market analyses with a satchel of salt; they all have some inadequacies.

Discussing what they call the "controversial" DTC genetic-testing sector, the RNCOS authors are themselves unsure of that market segment — reason enough to have left it out of the picture.

"With the FDA intervention [aimed at prohibiting selling DNA-based tests directly to consumers], the subject has become more significant, and it would be interesting to see whether new regulations do come in or not," the report says. [Emphasis added.]

Back in BRCA

As for the BRCA1/2 patent reversal, the Court of Appeals for the Federal Circuit's 2-1 decision Friday "returned the law to the state it was in" before a lower court last March found Myriad's two patents unpatentable. That decision would have eventually meant bad news by implication for any for gene-based assay-making lab that wanted to patent human genes.

The long-anticipated decision, which was largely expected in molecular-diagnostic and legal circles, affirmed the lower, District Court's decision on "standing, reversed the decision regarding isolated DNA claims, and affirmed the decision of unpatentability for method claims reciting merely 'comparison' steps, on the grounds that these claims failed the machine or transformation test from Bilski."

Not surprisingly, Myriad Genetics welcomed the news, saying it "strongly support[s] the Court's decision that isolated DNA and cDNA are patent-eligible material as both are new chemical matter with important utilities which can only exist as the product of human ingenuity."

"[W]e believe this decision is in the best interests of the agriculture, biotechnology, and pharmaceutical industries, as well as the hundreds of millions of people whose lives are bettered by the products these industries develop based on the promise of strong patent protection," Myriad Genetics CEO Peter Meldrum said.

Not so the American Civil Liberties Union, the chief plaintiff in the case against the BRCA1/2 genes in particular and human gene patenting broadly.

The District Court's ruling "is a blow to the idea that patent law cannot impede the free flow of ideas in scientific research," said Chris Hansen, a staff attorney with the American Civil Liberties Union Speech, Privacy and Technology Project.

"Human DNA is not a manufactured invention, but a natural entity like air or water," he added. "To claim ownership of genetic information is to unnecessarily block the free exchange of ideas."

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