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  • Pages
  • Editions
01 Cover
02 Welcome Letter / Sections
03 Article & Interview Directory
04 Section 1: Introduction
05 Introduction to US Life Sciences
06 Janssen Pharmaceuticals Interview
07 Investment Climate
08 MPM Capital Interview
09 Signet Healthcare Partners Interview
10 Xontogeny Interview
11 Insights from EisnerAmper
12 The Life Sciences Regulatory Climate
13 Buchanan Ingersoll & Rooney PC Interview
14 PhRMA Interview
15 PBOA Interview
16 Ernst & Young LLP Interview
17 LaVoieHealthScience Interview
18 Section 2: Introducing the Hubs
19 East Coast
20 BioNJ Interview
21 MassBio Interview
22 Pennsylvania Biotechnology Center Interview
23 West Coast
24 Biocom California Interview
25 QB3-Berkeley Interview
26 Section 3: Drug Discovery and Development
27 Therapeutic Fields On Fire
28 Insmed Interview
29 Mammoth Biosciences Interview
30 Innovations Enhancing the Patient Experience
31 Arcturus Therapeutics Interview
32 Karius Interview
33 Expert Insights: Targeted Therapeutics
34 First Wave BioPharma Interview
35 Aphios Corporation Interview
36 Section 4: Contract Manufacturing and Chemicals
37 A Shifting Landscape
38 Syngene International Interview
39 Cambrex Interview
40 Lubrizol Life Science Interview
41 Aenova Group Interview
42 Keeping Up With Demands
43 Cureline Interview
44 Interview: Murli Krishna Pharma
45 PsychoGenics Interview
46 Expert Insights: Innovative Technologies
47 AMPAC Fine Chemicals Interview
48 TCG Lifesciences Interview
49 CordenPharma Interview
50 Quotient Sciences Interview
51 A Post-Pandemic World
52 New Vision Pharmaceuticals Interview
53 Adare Pharma Solutions Interview
54 Ascendia Pharmaceuticals Interview
55 Chemicals Producers and Distributors
56 Brenntag North America Interview
57 BASF Pharma Solutions Interview
58 Section 5: Technology Services
59 Life Sciences Go Digital
60 RxS Interview
61 Insights from Markem-Imaje
62 AiCure Interview
63 WhizAI Interview
64 Section 6: Company Profiles
65 Brenntag Company Profile
66 Adare Pharma Solutions Company Profile
67 Quotient Sciences Company Profile
68 SK pharmteco Company Profile
69 AiCure Company Profile
70 Markem-Imaje Company Profile
71 TCG Lifesciences Company Profile
72 Murli Krishna Pharma Company Profile
73 Credits

Alec Ford, CEO,

KARIUS

"Our test helps clinicians non-invasively and rapidly diagnose infections in patients, particularly those enduring arduous forms of cancer treatment, most of whom will experience some degree of immunosuppression."

What are the most exciting advancements of Karius over the past few years?

Karius is growing quickly – the company has expanded from around 50 people in October 2020 to nearly 200 today. We have improved our Karius Test offerings, and whereas we used to have a few dozen hospitals ordering from us, we now have hundreds of hospitals that have used the test. These hospitals are primarily leading oncology, solid organ, and stem cell transplant institutions. Moreover, we are uniquely used in children's hospitals around the country.

In 2022, we will probably achieve one of the most important milestones in Karius’ history, which will be the readout of a prospective study called PICKUP —an observational trial designed to examine the efficacy of the Karius Test in immunocompromised patients with pneumonia. To put this in context, there are over 600,000 cancer-related deaths in the US each year. Up to half of those are from infection, with pneumonia being the main infection. People get very excited about new therapeutics and diagnostics to screen for cancer, but one of the top threats to a cancer patient today is not a malignancy, but an infection. The application of the Karius Test in this way has monumental implications.

Can you speak to the range of therapeutic applications of the Karius Test?

Our test helps clinicians non-invasively and rapidly diagnose infections in patients, particularly those enduring arduous forms of cancer treatment, most of whom will experience some degree of immunosuppression. Our core focus is on cancer and immunocompromised patients, solid organ transplantation, stem cell transplantation, and pediatrics.

We also have another trial in immunocompromised patients with invasive fungal infections, which have some of the highest mortality rates and are very difficult to diagnose and treat. Finally, we have another data set coming out in 2022 relative to both adult and pediatric patients undergoing stem cell transplantation and diagnosing critical infections.

What are the advantages of having a diagnostics test based on microbial cell-free DNA?

The unique advantage of our liquid biopsy test is that it does not require an invasive sample collection of infected tissue or fluid. Instead, it detects small fragments of DNA from the pathogen causing the infection within the bloodstream. In this way, we can find over 1,000 different pathogens from the site of the infection, irrespective of where the infection is in the body. Our internal analysis of data from a recent third party study showed that roughly 60% of invasive diagnostic procedures could have been avoided had the Karius Test been used instead. This is critical, as 30% of people who have one of those procedures could have an adverse event, and the average cost of that adverse event is US$15,000 per patient to the healthcare system.

A second advantage of our test, as evidenced by the clinical validation data, is its ability to often identify the underlying causes of more infections compared to standard of care. We can identify the likely pathogen causing infection typically within 24 hours of receiving the sample.

How has the medical community responded to the Karius Test?

Our test is performed in a CLIA certified and CAP accredited laboratory. Last year, we received approval from the New York State Department of Health's Clinical Laboratory Evaluation Program (CLEP). The decision by CLEP is a first-in-class approval of a clinical metagenomics test for the detection of infectious diseases and will expand patient access to critical testing in New York. Additionally, we have been featured in over 100 publications that provide clinical evidence for our product. We were published in Nature Microbiology in 2019 for a study that illustrated the validation of the Karius Test, examining its ability to identify the likely pathogens causing sepsis in hundreds of patients.

What potential does the power of genomics hold for the future of diagnostics?

Advanced genomics is still a relatively young industry, which had its origins in oncology and prenatal treatment and diagnosis. The industry focus has traditionally been therapeutic-centric, but the pandemic raised public awareness around the importance of rapidly and accurately diagnosing infections. We are excited to help advance the field of diagnostics with a liquid biopsy for infectious diseases.

Next:

Expert Insights: Targeted Therapeutics