Disease

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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.”

 

YC startup Felix wants to replace antibiotics with programmable viruses

Right now the world is at war. But this is no ordinary war. It’s a fight with an organism so small we can only detect it through use of a microscope — and if we don’t stop it, it could kill millions of us in the next several decades. No, I’m not talking about COVID-19, though that organism is the one on everyone’s mind right now. I’m talking about antibiotic-resistant bacteria.

You see, more than 700,000 people died globally from bacterial infections last year — 35,000 of them in the U.S. If we do nothing, that number could grow to 10 million annually by 2050, according to a United Nations report.

The problem? Antibiotic overuse at the doctor’s office or in livestock and farming practices. We used a lot of drugs over time to kill off all the bad bacteria — but it only killed off most, not all, of the bad bacteria. And, as the famous line from Jeff Goldblum in Jurassic Park goes, “life finds a way.”

Enter Felix, a biotech startup in the latest Y Combinator batch that thinks it has a novel approach to keeping bacterial infections at bay – viruses.

Phage killing bacteria in a petri dish

It seems weird in a time of widespread concern over the corona virus to be looking at any virus in a good light but as co-founder Robert McBride explains it, Felix’s key technology allows him to target his virus to specific sites on bacteria. This not only kills off the bad bacteria but can also halt its ability to evolve and once more become resistant.

But the idea to use a virus to kill off bacteria is not necessarily new. Bacteriophages, or viruses that can “infect” bacteria, were first discovered by an English researcher in 1915 and commercialized phage therapy began in the U.S. in the 1940’s through Eli Lilly and Company. Right about then antibiotics came along and Western scientists just never seemed to explore the therapy further.

However, with too few new solutions being offered and the standard drug model not working effectively to combat the situation, McBride believes his company can put phage therapy back at the forefront.

Already Felix has tested its solution on an initial group of 10 people to demonstrate its approach.

Felix researcher helping cystic fibrosis patient Ella Balasa through phage therapy

“We can develop therapies in less time and for less money than traditional antibiotics because we are targeting orphan indications and we already know our therapy can work in humans,” McBride told TechCrunch . “We argue that our approach, which re-sensitizes bacteria to traditional antibiotics could be a first line therapy.”

Felix plans to deploy its treatment for bacterial infections in those suffering from cystic fibrosis first as these patients tend to require a near constant stream of antibiotics to combat lung infections.

The next step will be to conduct a small clinical trial involving 30 people, then, as the scientific research and development model tends to go, a larger human trial before seeking FDA approval. But McBride hopes his viral solution will prove itself out in time to help the coming onslaught of antibiotic resistance.

“We know the antibiotic resistant challenge is large now and is only going to get worse,” McBride said. “We have an elegant technological solution to this challenge and we know our treatment can work. We want to contribute to a future in which these infections do not kill more than 10 million people a year, a future we can get excited about.”

GM and Ventec Life Systems partner to ramp up production of ventilators

GM said Friday that it is working with Ventec Life Systems to help increase production of respiratory care products such as ventilators that are needed by a growing number of hospitals as the COVID-19 pandemics spreads throughout the U.S.

The partnership is part of StopTheSpread.org, a coordinated effort of private companies to respond to COVId-19, a disease caused by coronavirus.

Ventec will use GM’s logistics, purchasing and manufacturing expertise to build more ventilators. The companies did not provide further details such as when production might be able to ramp up or how many ventilators would be produced.

GM Chairman and CEO Mary Barra said in a statement that GM is working closely with Ventec to rapidly scale up production.

“We will continue to explore ways to help in this time of crisis,” Barra added.

The need for ventilators is urgent as cases of COVID-19 pop up with increasing frequency as widespread testing begins. While some people with COVID-19 reported more mild symptoms, others have experienced severe respiratory problems and need to be hospitalized.

The shortage has prompted automakers to investigate ways of ramping up ventilator production. Volkswagen and Ford have reportedly either talked to the White House or committed to looking at the problem. Volkswagen said Friday it has created a task force to look into using 3D printing to make hospital ventilators.

Elon Musk tweeted Friday that Tesla and SpaceX  employees are “working on ventilators” even though he doesn’t believe they will be needed. His confirmation on Twitter that both of the companies he leads are working on ventilators comes a day after New York City Mayor Bill de Blasio made a direct plea to Musk to help alleviate a shortage at hospitals gearing up to combat COVID-19.

Musk didn’t provide specifics what “working on ventilators” means, what Tesla factory might be used, the possible capacity or when he planned to begin production.

The Chan Zuckerberg Biohub invests $50 million in its first 47 research initiatives

chan-zuckerberg The Chan Zuckerberg Biohub, a non-profit medical research organization started by Priscilla Chan and Mark Zuckerberg (and not to be confused with the Chan Zuckerberg Initiative, a limited liability corporation to advance human potential) today announced it would be doling out a total of $50 million to its first cohort of disease investigators.
The Biohub brings together Bay Area… Read More

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