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NEA-backed Personal Genome Diagnostics receives FDA clearance for its cancer diagnostic

Personal Genome Diagnostics, the venture-backed developer of a novel diagnostic kit for genomic profiling of different cancers in lab settings, has received clearance from the U.S. Food and Drug Administration for its PGDx elio tissue complete test.

The test’s approval is another step forward for precision therapies that rely on an understanding of the unique genomic profile of an individual patient’s tumor, according to the company.

The test detects single nucleotide variants and the small insertions and deletions known as indels. Single nucleotide variants, indels, and identifying characteristics like the tumor mutation burden can be used by physicians to determine how rapidly a disease like cancer to progress and can provide essential targets for precision therapies to individual tumors.

The information doctors collect from these tests can also be used to help oncologists identify patients for clinical trials.

The new diagnostics test cover 35 different tumor types.

“There has not, until this point, been one standardized test for all kinds of cancer that any lab across the country can perform,” said Dr. Pranil Chandra, Chief Medical Officer of Genomic and Clinical Pathology Services, PathGroup, an early collaborator for PGDx elio tissue complete, in a statement. “With this clearance, labs across the country will for the first time have an option for a regulated, standardized test that examines a broad view of cancer pathways and genomic signatures across advanced cancers.”

To date, Personal Genome Diagnostics has raised over $99 million, according to Crunchbase. The company’s investors include New Enterprise Associates, Bristol Myers Squibb, Inova Strategic Investments, Co-win Healthcare Fund, Helsinn Investment Fund, Windham Venture Partners, Maryland Venture Fund

“We are proud to have led the first institutional round for PGDx,” said Dr. Justin Klein, in a statement when the company raised a $75 million round back in 2018. “Rapid advances in immuno-oncology, targeted agents, and combination cancer therapies are heightening the importance of tumor genome testing that enables treatments to be targeted to those patients most likely to benefit.”

 

Ancestry lays off 6% of staff as consumer genetic testing market continues to decline

Excitement in the consumer genetic testing market continues to show signs of slowing down.

In the past two weeks layoffs have hit two of the biggest consumer genetic testing services — 23andme and Ancestry — with the latter announcing that it would slash its staff by 6% earlier today, in a blog post.

CNBC first reported the news.

In her blogpost announcing the layoffs, Ancestry chief executive Margo Georgiadis wrote:

… over the last 18 months, we have seen a slowdown in consumer demand across the entire DNA category. The DNA market is at an inflection point now that most early adopters have entered the category. Future growth will require a continued focus on building consumer trust and innovative new offerings that deliver even greater value to people. Ancestry is well positioned to lead that innovation to inspire additional discoveries in both Family History and Health.

Today we made targeted changes to better position our business to these marketplace realities. These are difficult decisions and impact 6 percent of our workforce. Any changes that affect our people are made with the utmost care. We’ve done so in service to sharpening our focus and investment on our core Family History business and the long-term opportunity with AncestryHealth.

The move from Ancestry follows job cuts at 23andMe in late January, which saw 100 staffers lose their jobs (or roughly 14% of its workforce.

The genetic testing company Illumina has been warning of softness in the direct to consumer genetic testing market, as Business Insider reported last August.

“We have previously based our DTC expectations on customer forecasts, but given unanticipated market softness, we are taking an even more cautious view of the opportunity in the near-term,” the company’s chief executive Francis deSouza said in a second quarter earnings call.

Consumers seem to be waking up to the privacy concerns over how genetic tests can be used.

“You can cancel your credit card. You can’t change your DNA,” Matt Mitchell, the director of digital safety and privacy for the advocacy organization Tactical Tech, told Business Insider earlier in the year.

And privacy laws in the U.S. have not caught up with the reality of how DNA testing is being used (and could potentially be abused), according to privacy experts and legal scholars.

“In the US we have taken to protecting genetic information separately rather than using more general privacy laws, and most of the people who’ve looked at it have concluded that’s a really bad idea,” Mark Rothstein, a law professor at Brandeis and the director of the University of Louisville’s Institute for Bioethics, Health Policy and Law, told Wired in May.

The investigation into the “Golden State Killer” and the eventual arrest of Joseph James DeAngelo thanks to DNA evidence collected from an open source genealogy site called GEDMatch likely helped focus consumers thinking on the issue.

In that case a relative of DeAngelo’s had uploaded their information onto the site and investigators found a close match with DNA at the crime scene. That information was then correlated with other details to eventually center on DeAngelo as a suspect in the crimes.

While consumer genetic testing services may be struggling, investors still see increasing promise in clinical genetics testing, with companies like the publicly traded InVitae seeing its share price rally and the privately held company, Color, raising roughly $75 million in new capital from investors led by T. Rowe Price.

 

CRISPR scientist in China claims his team’s research has resulted in the world’s first gene-edited babies

In what represents a dramatic and ethically fraught escalation of CRISPR research, a Chinese scientist from a university in Shenzhen claims he has succeeded in helping create the world’s first genetically-edited babies. Dr. Jiankui He told the Associated Press that twin girls were born earlier this month after he edited their embryos using CRISPR technology to remove the CCR5 gene, which plays a critical role in enabling many forms of the HIV virus to infect cells.

The AP’s interview was published after a report by the MIT Technology Review earlier today that He’s team at the Southern University of Science and Technology wants to use CRISPR technology to eliminate the CCR5 gene and create children with resistance to HIV.

He’s claims are certain to cause a huge stir at the Second International Summit on Human Genome Editing, set to begin in Hong Kong on Tuesday. According to the Technology Review, the summit’s organizers were apparently not notified of He’s plans for the study, though the AP says He informed them today. (It is important to note that there is still no independent confirmation of He’s claim and that it has not been published in a peer-reviewed journal.)

During his interview with the AP, He, who studied at Rice and Stanford before returning to China, said he felt “a strong responsibility that it’s not just to make a first, but also make it an example” and that “society will decide what to do next.”

According to documents linked by the Technology Review, the study was approved by the Medical Ethics Committee of Shenzhen HOME Women’s and Children’s Hospital. The summary on the Chinese Clinical Trial Registry also said the study’s execution time is between March 7, 2017 to March 7, 2019, and that it sought married couples living in China who met its health and age requirements and are willing to undergo IVF therapy. The research team wrote that their goal is to “obtain healthy children to avoid HIV providing new insights for the future elimination of major genetic diseases in early human embryos.”

A table attached to the trial’s listing on the Chinese Clinical Trial Registry said genetic tests have already been carried out on fetuses of 12, 19, and 24 weeks of gestational age, though it is unclear if those pregnancies included the one that resulted in the birth of the twin girls, whose parents wish to remain anonymous.

“I believe this is going to help the families and their children,” He told the AP, adding that if the study causes harm, “I would feel the same pain as they do and it’s going to be my own responsibility.”

Chinese scientists at Sun Yat-sen University in Guangzhou first edited the genes of a human embryo using CRISPR technology (the acronym stands for Clustered Regularly Interspaced Short Palindromic Repeats), which enables the removal of specific genes by acting as a very precise pair of “genetic scissors,” in 2015. Though other scientists, including in the United States, have conducted similar research since then, the Southern University of Science and Technology’s study is considered especially radical because of the ethical implications of CRISPR, which many scientists fear may be used to perpetuate eugenics or create “designer babies” if carried out on embryos meant to be carried to term.

As in the United States and many European countries, using a genetically-engineered embryo in a pregnancy is already prohibited in China, though the Technology Review points out that this guideline, which was issued to IVF clinics in 2003, may not carry the weight of the law.

In 2015, shortly after the Sun Yat-sen University experiment (which was conducted on embryos that were unviable because of chromosomal effects) became known, a meeting called by several groups, including the National Academy of Sciences of the United States, the Institute of Medicine, the Chinese Academy of Sciences and the Royal Society of London, called for a moratorium on making inheritable changes to the human genome.

In addition to ethical concerns, Fyodor Urnov, a gene-editing scientist and associate director of the Altius Institute for Biomedical Sciences, a nonprofit in Seattle, told the Technology Review that He’s study is cause for “regret and concern” because it may also overshadow progress in gene-editing research currently being carried out on adults with HIV.

TechCrunch has contacted He for comment at his university email.

Pittsburgh’s Kerf Cases enrobes your phone in fine wood

 One iPhone case is much like the other unless it’s made of figured walnut wood from a retired woodworker in California and feels like the surface of a finely-sanded and well-made piece of antique cabinetry. That’s why Kerf Cases, a Pittsburgh-based manufacturer, is so cool.
The founder, Ben Saks, has been working in wood for most of his life. While working at Carnegie Mellon… Read More

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CRISPR-Cas9 inventor Jennifer Doudna’s plans on moving forward, genetically modifying humans

PARIS, FRANCE - MARCH 24:  Laureate Professor Jennifer Doudna (for reinventing genetic research - she's from USA) attends the  The decision of who owned the rights to a hotly disputed CRISPR gene editing patent came down in favor of the Broad Institute of MIT and Harvard today so you’d think the mood would be sour at the University of California, Berkeley, the other contender in the case. But Berkeley’s Jennifer Doudna tells TechCrunch this is a positive for her. “I’m actually delighted to know… Read More

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This fish hunts by spitting water at its prey

The Archerfish of Southeast Asia and Australia spit at perched insects to knock them into the water for an easy meal. From KQED’s “Deep Look“:

“When the fish fires the shot,” (Wake Forest University biologist Morgan) Burnett explained, citing the work of other researchers in Germany who first used high-speed cameras to observe the projectiles in 2014, “the water leaves the mouth as essentially a very long stream. But during flight, the stream merges into a ball.”

The fish accomplishes this feat of timing through deliberate control of its highly-evolved mouthparts, in particular its lips, which act like an adjustable hose that can expand and contract while releasing the water.

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Women’s health startup Celmatix now offers genetic testing for fertility issues

pregnant Celmatix, a startup with a focus on personalized medicine for women, wants to take some of the mystery out of the science of baby-making with a new type of DNA-based fertility test called Fertilome. Fertilome looks at 49 variants in 32 different genes that give you a likelihood or not for inherited disorders such as endometriosis or PCOS to help women determine the best course of action to… Read More

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