Pictorlabs is a California-based startup developing a cloud-based platform that uses artificial intelligence to improve tissue sample analysis through virtual histological staining.

In Episode #34 of the Speed to Data Podcast, Key Tech’s Andy Rogers speaks with Pictorlabs Chief Product Officer Raymond Kozikowski about his company’s all-digital approach to tissue sample testing.

Need to know

· Histopathology — The visual analysis of stained tissue samples to diagnose cancer and other conditions.

· Tests have long turnaround times — Selection, preparation, and imaging can take as long as a day to return one test’s results to the physician.

· Tests are requested sequentially — The results of one test determine the next test in the decision tree, so physicians can’t order all the tests simultaneously.

· Cancer patients must wait — On average, there is a forty-day gap between biopsy and first treatment.

The nitty-gritty

As Dr. Kozikowski explains, “Histopathology has traditionally been a chemistry-based testing paradigm. Every cancer case starts with a biopsy, and those tissues are transformed into data that inform the diagnosis and therapeutic options.”

Pictorlabs’ solution uses one tissue sample to create a virtual stain that simultaneously generates results for dozens of tests within minutes.

“What we’re doing is teaching AI algorithms the relationship between validated test results and the underlying signature from that unstained piece of tissue,” Dr. Kozikowski said. “From a single patient sample, you’re no longer limited to running one chemical-based test. You can run ten, twenty, thirty AI-based tests.”

Although the company thought it faced a long march toward the clinical market, Pictorlabs found an opportunity in a different market.

“There’s a really robust cancer research market, both the academic medical centers and the pharma companies. Where we really got traction wasn’t necessarily as a replacement [technology] but a complement to other kinds of tests.”

Dr. Kozikowski cites spatial biology as an example. Cells express their genes and RNA differently depending on their location in tissue. Understanding this spatial relationship could yield new, more targeted therapies.

“A challenge with interrogating RNA targets,” Dr. Kozikowski explains, “is that you often can’t also run traditional staining-based tests. With virtual staining, we’re actually able to complement those RNA-based tests with a pseudo-staining result. This is perfectly fit for purpose in those workflows.”

Data that made the difference:

The importance of data to AI development isn’t surprising, but Pictorlabs needs more than quantity.

“There’s also a lot of nuance in the design of that dataset and making sure it’s fit for purpose,” Dr. Kozikowski says. “Has it seen the diversity of human disease in that training dataset to really make sure that it generalizes accurately and robustly?”

Partnerships with the research community have helped refine Pictorlab’s technology. One of these relationships is with Dr. Michael Kallen, a pathologist at the University of Maryland’s School of Medicine.

“Diagnosing lymphoma or leukemia can be very, very complex. You have the challenge of managing a complex workflow in the lab and the complexity of making sense of all those test results spread over weeks or maybe even a month.”

“[Dr. Kallen] saw the opportunity. We’ve been partnered with that department for a while now, exchanging data to help train algorithms and get feedback from pathologists. We’ve just received an innovation grant to deploy our technology side-by-side with their existing workflows to look at the value.”

Watch the full video below to learn more about Pictorlabs’ virtual staining solution and to hear Dr. Kozikowski’s advice to product managers and entrepreneurs.

Astek Diagnostics is a Baltimore-based MedTech startup developing a platform for diagnosing urinary tract infections (UTIs) with unprecedented speed and accuracy.

In Episode #33, Key Tech’s Andy Rogers and Lauren Eskew discuss this exciting development with Astek Diagnostics co-founder and CEO Dr. Mustafa Al-Adhami.

Need to know

• UTIs are proliferating — Within thirty years, global cases rose 90% to over 400 million cases[CC1] , with over 8 million hospital visits in the US alone.
• Rapid tests are unreliable — Low-specificity dipsticks have high false-positive rates.
• Clinical tests are slow — Labs take up to three days to return results.
• Incorrect prescriptions are common — Physicians initially choose the wrong antibiotics in half of patients, delaying effective treatment.
• UTI complications are lethal — 25% of sepsis cases start as UTIs, leading to 68,000 deaths in the US[CC2] .
• Slow, inaccurate diagnoses breed resistant bacteria — Delaying the use of effective antibiotics contributes to the severe threat of antimicrobial resistance.

The nitty-gritty

Dr. Al-Adhami’s entrepreneurial journey began with a personal crisis two months before receiving his biomedical engineering Ph.D. when his grandfather developed a UTI.

“It took the doctors four days to tell him what antibiotic he should be using,” Dr. Al-Adhami said. “In the meantime, he was in pain. He was delirious. He fell and broke his hip. I kid you not, he was a young 87-year-old. Within one week, he was a much, much older, bedridden 87-year-old. [While] helping with his care, I was like, if we were able to give him the proper antibiotic right away, we would not be here!”

Such strong motivation led to a one-hour test for use in a urology or OB/GYN clinic. The system has two components: a single-use sample cartridge and a durable microfluidics fluorescent analyzer that characterizes antibiotic susceptibility[CC3] . Astek’s tabletop prototype already achieves 97% specificity and 94% sensitivity — results that would revolutionize UTI treatment worldwide.

Data that made the difference

Working with Key Tech, Dr. Al-Adhami’s team will soon have an alpha product ready to begin feasibility studies. Shortly afterward, the beta design will enter clinical trials with a planned FDA submission by the second quarter of 2025 — a remarkable four years after the company’s founding.

“The patients are waiting, right?” Dr. Al-Adhami pointed out. “Luckily, my grandfather is still with us. The goal here is to help with my grandfather's situation, so I need to get this to market as soon as possible.”

While Dr. Al-Adhami and co-founder Kevin Tran saw the market need, they needed data from their first prototype to show potential investors. “We ran fifteen samples, and the device was spot on with thirteen of the fifteen. It was like, this works! This is not a bad idea! I was confident enough to raise a pre-seed round. To say, ‘Hey, angel investor, can I have 50K?’”

Further market research helped shape pricing and reimbursement models that benefit the company and physicians.

“More importantly,” Dr. Al-Adhami said, “the patient is getting better. That makes it sustainable. The idea here is to shorten the [hospital stay]. We did a health economics study. If we shorten the stay [for all patients] by one day, we’re saving the hospital — per site — a million dollars a day.”

Watch the full video below for more details and to hear Dr. Al-Adhami’s advice for MedTech founders.

[CC1]From Key Tech/Astek press release

[CC2]From Astek’s website

[CC3]From Key Tech/Astek press release

Blackbird Labs is a life sciences accelerator with a mission to develop Baltimore’s biotech startup ecosystem. Funded by the owners of the Baltimore Ravens, Blackbird’s focus is on bridging the gap between research labs and clinical trials.

In Episode #32, Andy Rogers of Key Tech talks with Blackbird Labs CEO Matt Tremblay about Blackbird’s integrated initiative to foster life science and biotech research in Baltimore.

Need to know

Building Baltimore’s biotech infrastructure — The Baltimore area is home to some of the nation’s top biotech research institutions with lots of mid-career talent, but a relatively underdeveloped investor ecosystem compared to Silicon Valley.

Building a thriving ecosystem — With a mission to foster entrepreneurship and reduce Baltimore’s opportunity gap, Baltimore Ravens owner Steve Bisciotti’s family foundation wants to develop the region’s biotech innovation.

Blackbird Labs gets innovations out of the lab — A $100 million founding grant will let Blackbird Labs accelerate life sciences innovation by helping promising research cross the gap separating the lab from the market.

Blackbird Bioventures moves startups towards the market — Making seed-stage investments and cultivating a network of investors, advisors, and leaders will help biotech startups shift from research to clinical trials.

The nitty-gritty

Blackbird Labs and Blackbird Bioventures address a significant hurdle preventing novel therapies and technologies from reaching the market. A laboratory discovery is too risky for investors. There are too many open questions concerning safety and efficacy.

“When a new therapeutic is identified,” Tremblay explains, “we can’t just immediately go into a clinical study.”

Blackbird Labs attacks the problem from one end by funding research at universities and contract labs that no longer fits within the academic systems of publications and grant-making.

“What you may need is another one to two years of very focused research to create the data that will then draw in investors that can support the development of this technology all the way to market.”

That is when Blackbird Bioventures enters the picture. Startups need capital to prepare for and enter clinical trials, which Blackbird’s early seed investments and investor networks help provide. Since its launch last November, Tremblay’s organization has already awarded grants to six research teams and invested in four existing startups.

Data that made the difference:

“An important element of our business model is syndicating with other investors but also strategic partners like Big Pharma,” Tremblay says. “We have a few different layers of challenges to overcome. We’re not just looking at… commercial potential, but we also have to look at the feasibility on a one to three-year timescale.”

The goal is to generate what Tremblay calls “prudent principal data” to excite potential investors. This data must meet two criteria. First, is there a strong mechanistic underpinning for therapy’s efficacy? Second, can the project generate clinical data on a meaningful timescale to show that the therapeutic works?

Blackbird’s data and investments, Trembly explains, “is a signal to the market that this is an important technology. The goal is then to bring investors from within the Baltimore ecosystem — but importantly from outside of the mid-Atlantic —folks that are investing in very high-quality companies in Boston and San Francisco to look at what we’re building here.”