Russ Cohen

Haystacking Progress: Quest Diagnostics’ MRD Deal Haystacking Progress: Quest Diagnostics’ MRD Deal

Quest Diagnostics’ DGX subsidiary, Haystack Oncology, and Lisata Therapeutics,
Inc.
LSTA recently announced a research collaboration for using the
Haystack MRD (minimal residual disease) technology. Under the partnership, Lisata will deploy the highly
sensitive technology to detect the circulating tumor DNA (ctDNA) in a clinical study evaluating certepetide
plus chemotherapy as an investigational treatment for metastatic pancreatic cancer.

DGX completed the validation of the Haystack MRD test in March 2024. The Haystack MRD Early Experience Program
has been oversubscribed, with nearly 20 leading cancer institutions as participants, paving the way for a
nationwide launch of the clinical test later this year.

Discovery in Lisata Therapeutics

As a clinical-stage pharmaceutical company, Lisata focuses on the discovery, development, and commercialization
of innovative therapies for the treatment of advanced solid tumors and other major diseases. The company’s
lead product candidate, certepetide, is an investigational drug designed to activate a novel uptake pathway
that allows co-administered or tethered anti-cancer drugs to target and penetrate solid tumors more
effectively.

Building on its CendR Platform Technology, Lisata has forged noteworthy commercial and R&D partnerships. The
company expects to announce several clinical studies and business achievements over the next two years and
projects that its available capital will fund operations into early 2026.

Delving into the FORTIFIDE Study

The FORTIFIDE study investigates the safety, tolerability, and efficacy of certepetide when given as a
four-hour continuous infusion in combination with standard-of-care treatment in subjects with metastatic
pancreatic ductal adenocarcinoma (mPDAC) who have progressed on FOLFIRINOX, a treatment for pancreatic cancer.
According to the estimates of the American Cancer Society, more than 66,000 individuals nationwide will be
diagnosed with pancreatic cancer in 2024, with mPDAC accounting for more than 90% of these cases. Known for its
highly aggressive form, the disease mainly advances to this stage due to a lack of early diagnosis or limited
patient response to treatments.

Zacks Investment Research

Image Source: Zacks Investment Research

The research will use Haystack’s MRD technology to measure serum ctDNA levels at multiple time points in
patients throughout the study as an exploratory endpoint for analyzing the early therapeutic effect of
certepetide. According to a Haystack Oncology representative, the collaboration underscores the value of the
Haystack MRD technology in helping drive forward the development of novel treatments for solid tumor cancers.

Designed to detect ctDNA with exceptional sensitivity, Haystack’s technology aims to provide crucial insights
into ctDNA kinetics via serial measurements as an important and early indication of therapeutic response.

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Industry Prospects

Per a Markets And Markets research report, the global MRD testing market was valued at $1.2 billion in 2022 and
is expected to witness a CAGR of 14% by 2027. The market continues to be driven by the rising incidence and
prevalence of cancer and hematological malignancies.

Significant Collaborations with MRD Technology

Earlier, in January 2024, Haystack Oncology announced a research collaboration with TriSalus Life Sciences to
evaluate the therapeutic response and provide molecular insights in connection with the clinical development
of TriSalus’ SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist.

Additionally, Quest Diagnostics partnered with Ultima Genomics, involving the latter’s next-generation
sequencing technology in oncology and other clinical areas. DGX aims to deploy the Ultima technology for the
possible development of lab-developed tests involving its Haystack solid-tumor MRD technology for future
clinical and biopharmaceutical MRD applications, supplementing its current whole exome sequencing approach, as
well as for certain future whole genome testing applications, such as rare disease detection in pediatric
patients.

Exploring Price Performances

In the past year, shares of DGX have declined 2.8% against the industry’s rise of 11%.

Zacks Rank and Other Standouts

Quest Diagnostics currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the broader medical space are Globus Medical GMED and Hims &
Hers Health
HIMS. While Globus Medical sports a Zacks Rank #1 (Strong Buy), Hims
& Hers Health carries a Zacks Rank #2 at present.

Globus Medical shares have risen 20% in the past year. Estimates for the company’s earnings have remained
constant at $2.82 in 2024 and at $3.32 in 2025 in the past 30 days.

GMED’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 10.8%.
In the last reported quarter, it posted an earnings surprise of 30.9%.

Estimates for Hims & Hers Health’s 2024 earnings per share have moved upward 5.3% to 20 cents in the past 30
days. Shares of the company have surged 173% in the past year against the industry’s 22.2% fall.

HIMS’ earnings surpassed estimates in three of the trailing four quarters and missed in one, the average surprise
being 79.2%. In the last reported quarter, it delivered an earnings surprise of a staggering 150%.