Bioinformatics/IT
Pennsylvania Seeks Expansion of its Forensic DNA Database
Jennifer K. Wagner, J.D., Ph.D., is a solo-practicing attorney in State College, PA, a research associate at the University of Pennsylvania’s Center for the Integration of Genetic Healthcare Technology.
Last month, the Pennsylvania General Assembly voted in favor of a bill that would expand the Commonwealth’s criminal database. PA Senate Bill 775 authorizes law enforcement to begin DNA fingerprinting of individuals upon arrest or charge for certain specified crimes (as opposed to only upon conviction) and authorizes familial searching of the state’s forensic database. After third consideration, the amended version of PA Senate Bill 775 passed by a vote of 42-6. The bill has been referred to the judiciary.
The bill had been introduced in March of 2011 by Pennsylvania Senate Majority Leader Dominic Pileggio, who was later joined by a dozen colleagues (including nine Republican and three Democratic sponsors). It immediately garnered the attention of genetics law scholars, including Penn State Dickinson’s School of Law Professor David Kaye, who submitted a thorough statement (pdf) for the Pennsylvania General Assembly’s consideration.
More News on DNA in Forensics
We recently noted that DNA profiling has greater public approval in the UK than in America. The UK presently operates the largest DNA database in the world with over 5 million profiles. Nevertheless, that country has just taken a giant step in the opposite direction. New civil liberties legislation, dubbed “the freedom bill,” will require authorities to remove hundreds of thousands of unconvicted people from the database, following a ruling from the European Court of Human Rights that “the blanket retention of DNA from people arrested but never convicted of any offence [i]s unlawful.” There are 1.1 million people without convictions presently profiled in the database; however, some of these profiles will not be removed as a result of an exception for “unconvicted terror suspects who have been released.”
Here in the U.S., the Supreme Court will consider the post-conviction DNA testing landscape in the Texas case of Henry Skinner. Thousands of convicts are requesting new DNA testing in light of the increasing number of exonerations based on DNA evidence. Skinner was convicted 15 years ago of murdering his girlfriend and her two developmentally disabled adult sons. At the recommendation of his attorneys, he declined DNA testing for his trial. Texas courts said he doesn’t currently qualify under a state law that grants DNA testing to some convicts, and federal courts refused to overrule Texas. The last time the Supreme Court considered this issue, in 2009, a divided court decided to let Congress and the state legislatures make the rules. Therefore, rules vary from jurisdiction to jurisdiction as to how requests for post-conviction DNA testing are handled. Perhaps this time the Supreme Court will decide to lay down some firmer ground rules.
Recent Developments in Forensic DNA
The use of DNA in forensics continues to expand. Last year, James Cass reviewed the current system of forensic DNA profiling in the U.S., including CODIS (the Combined DNA Index System, the FBI’s integrated DNA profiling program), the controversial practice of partial/familial searching, and calls from President Obama and others to collect DNA profiles for all Americans in a national database. He posted follow-up pieces focused on advance DNA collection under Katie’s Law, the growing backlog of DNA samples, and familial DNA database searching, which gained support after it facilitated the arrest of the elusive serial killer in California known as the Grim Sleeper.
A number of newer developments have caught our attention.
2011 Personal Genomics Preview: It’s Déjà Vu…
Last January we kicked off the new year by posing “Five Questions for Personal Genomics in 2010.” Here were the five questions we asked:
1. Will the $1,000 genome live up to the hype?
2. Will personal genomics stay DTC?
3. How will the ongoing gene patent debate affect the progress of personalized medicine?
4. When and where will the next regulatory shoe fall?
5. Who will control the data?
A year later the question that comes first to mind is, has anything really changed?
The short answer is no, not fundamentally, although that is not meant to imply that nothing of note happened in 2010. Far from it, as significant legal, regulatory, policy and technological developments continued to reshape the personal genomics landscape.
With that in mind, we welcome 2011 with a look back at the year that was, and a look ahead at what to expect from 2011 and beyond.
Induced Infringement Heads to Supreme Court Amid Myriad Takeover Speculation
On Monday we wrote about the Salzberg Screen—a do-it-yourself alternative to Myriad’s BRACAnalysis test to identify deleterious mutations in the BRCA genes. We wondered whether the Salzberg Screen, which is intended to allow users to “circumvent [Myriad’s] gene patents,” could expose its designers to indirect patent infringement liability.
In a related development, this week the Supreme Court decided to hear a case (Global-Tech Appliances, Inc. v. SEB S.A.) that asks whether the legal standard for the ‘state of mind’ element of an inducement of infringement claim under Section 271(b) of the Patent Act requires “purposeful, culpable expression and conduct” or merely “deliberate indifference.” The Court’s decision, which will not come until next year, will bear on the degree of knowledge of an alleged infringer required to make out a claim for inducement of infringement.
A Do-It-Yourself Genomic Challenge to Myriad, the FDA and the Future of Genetic Tests
Over the weekend, Steven L. Salzberg and Mihaela Pertea published a short but significant article in the journal Genome Biology. In “Do-it-yourself genetic testing,” Salzberg and Pertea describe the creation of “a computational screen that tests an individual’s genome for mutations in the BRCA genes, despite the fact that both are currently protected by patents.”
The software-based test can be downloaded from the website of the University of Maryland’s Center for Bioinformatics & Computational Biology, where Salzberg is the director and Pertea is on the faculty. The test purports to test genomic sequence data against a set of known mutations in the BRCA genes. In addition to representing a conceptual alternative for those seeking to evaluate their risk of hereditary breast cancer, the so-called “Salzberg Screen” is also a direct challenge to Myriad Genetics, the FDA and the existing legal, regulatory and policy regimes that continue to struggle to keep pace with the science and technology of genomics and personalized medicine.
Below, we examine how the Salzberg Screen fits—or does not—within the current legal and regulatory landscape, as well as what it signals for the future of do-it-yourself genomics, whole-genome sequencing and the law.
The Conversation Begins: Recap from Day One of FDA’s LDT Regulatory Meeting
Welcome to Hyattsville, MD, where we have just completed day one of FDA’s two day “Public Meeting on Oversight of Laboratory Developed Tests” (LDTs). The session was civil, well-organized and largely devoid of surprises. It did, however, mark the official kick-off of the FDA’s highly publicized decision to develop a “risk-based application of oversight” for all LDTs.
If you’re interested in the details of what was said and by whom you’ll find links at the bottom to all of the relevant transcripts, video feeds and Twitter coverage. For my part, here are the three key take-away points from day one:
Timing. Last week I wrote that it was unlikely that this meeting, or any of the other myriad regulatory and legislative proposals for LDT regulation, would produce a significant shift in the legal and regulatory landscape any time soon. One day of FDA meetings has done nothing to change that opinion.
Grim Sleeper Awakens Attention to Familial Searching of DNA Databases
Last week, the Los Angeles Police Department announced that it had captured a man suspected of being the “Grim Sleeper”: a serial killer linked with at least 10 murders over 25 years.1 The case marks the first time in the United States that a DNA search technique known as familial searching has led to an arrest in a homicide case.
As we’ve previously discussed, a partial match between two DNA profiles may indicate that the donors of the corresponding samples may be related. In familial searching, a database is searched for the purpose of identifying partial, rather than exact, matches against the sample of unknown origin. Those partial matches are then used as investigatory leads.
Though familial searching has been used with some success in other countries, few states openly endorse its practice. Those states that permit the use of partial matches at all generally prohibit the intentional search for those matches, requiring instead that they be discovered inadvertently. California began using familial searching in 2008 in a first attempt to identify the Grim Sleeper. At the time, the failure to produce a suspect was seen as a strike against the technique: if familial searching could implicate privacy concerns and subject innocent individuals to excessive genetic surveillance, it certainly could not be justified without being able to point to positive results.2 Since then, one DNA profile of particular interest was added to California’s database: that belonging to the son of the man now identified as the Grim Sleeper.
The Unintended Consequences of Katie’s Law: More DNA Samples Collected, More DNA Samples Untested?
Last month, we discussed a bill nicknamed “Katie’s Law” that would give states financial incentives to collect DNA samples from individuals arrested for certain crimes. At the moment, less than half of the states currently collect DNA samples from these arrestees. If Katie’s Law were enacted, the remainder of the states would likely expand the scope of their DNA collection practices, greatly increasing the number of samples collected.
But once DNA samples are collected, when are they actually analyzed? As discussed by Christopher Heaney and Sara Huston Katsanis in The Contra Costra Times, many states currently have considerable backlogs in testing DNA samples, including those collected from convicts, arrestees and victims. Katie’s Law, by increasing the number of samples that require analysis, is likely to exacerbate these backlogs. Worse yet, Heaney and Katsanis point out that other federal funding awards are determined by the size of a state’s backlog—the larger the backlog, the more funds the state can receive. While the intent of Katie’s Law is to expedite the delivery of justice, there is concern that its practical effect may indeed be just the opposite.
Keeping Up With CODIS and Katie’s Law
A few weeks back, we posted a discussion of the issues surrounding the current system of forensic DNA profiling, with an emphasis on the Combined DNA Index System (CODIS). In that post, we noted that the federal government had enacted a policy of taking DNA samples from individuals arrested for certain crimes and retaining the samples in CODIS. To date, 23 states have enacted similar laws, and the federal government may soon give the other 27 states incentives to follow suit.
On May 18, the House of Representatives passed the Katie Sepich Enhanced DNA Collection Act of 2010, informally known as Katie’s Law.1 Under the bill, those states that collect DNA from individuals arrested for certain serious crimes (murder, voluntary manslaughter, serious sexual offenses or serious kidnapping offenses) and compare the samples to those in the CODIS database at least once receive a 5% bonus on certain federal crime prevention grants.2 States that also collect samples from individuals arrested for less serious crimes and submit all profiles collected from arrestees for inclusion in CODIS would instead receive a 10% bonus. The bill is now with the Senate Committee on the Judiciary.
